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Why did the lead time you quoted last week change? Good question — remember, we estimate production lead times as of the day we quote. If the demand for the component grows — say 4 customers place orders the day after we provide your quote, the time it takes to manufacture components for orders in the queue lengthen, and your lead-time will increase — even just 24 hours after we quoted. How many lead times do I need to worry about? In actuality, there could be three or more lead times on most complete package orders, 1 Containers, 2 Closures, and 3 Deco application.

This means that there are multiple processes and components of fulfillment that can affect your lead-time. While container and closure lead-times may not be additive if the components are being manufactured concurrently , deco application is, since no decorating process can begin without receiving the manufactured container or closure.. What can I do to minimize impact from Lead Times Change? As a customer, having accurate usage forecast of all your packaging components will help minimize impacts in your supply chain due to unforeseen lead time changes.

View Inquiry Cart. Containers Glass containers, plastic containers, metal containers, thousands of selections, limitless possibilites. These comments suggest dietary supplement CGMP is focused on ensuring finished products are manufactured using quality procedures, but are not related to preventing adulteration.

Other comments state we should enforce current food CGMP regulations rather than adopt new regulations. Response We disagree that dietary supplement CGMP requirements are not related to preventing adulteration. In fact, under the statutory scheme a dietary supplement is deemed to be adulterated under section g 1 of the act if it fails to meet CGMP requirements we promulgate by regulation. As we discussed in section III of this document, dietary supplement CGMP requirements are necessary to ensure the quality of the dietary supplement; ensuring quality includes ensuring that the dietary supplement has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section a 1 , a 2 , a 3 , and a 4 of the act.

We also disagree with those comments stating that the requirements in part are adequate and that no additional requirements are necessary. The comments do not explain why the specific requirements set forth in the proposed rule that are not also in part are unnecessary. As discussed in greater detail in response to comments on our legal authority in section V of this document, the particular characteristics and hazards of dietary supplements call for CGMP requirements tailored to dietary supplements.

Congress specifically provided independent authority under section g of the act for us to promulgate CGMP requirements for dietary supplements. That authority would have been unnecessary if Congress had concluded that part was adequate. We also disagree that enforcement of part would eliminate a need for dietary supplement CGMP requirements. The dietary supplement CGMP requirements include practices specifically tailored to the characteristics and hazards of dietary supplements and their manufacturers. The comments asserting that current food CGMP requirements in part are sufficient provided no persuasive or compelling reasons for that assertion, or for why we should not implement dietary supplement CGMP requirements under section g of the act.

For these reasons, we are not persuaded by the comments that these dietary supplement CGMP requirements are not needed. Comment 5 Some comments object to the examples of manufacturing problems that we used to support the need for CGMP requirements. Specifically, some comments object to the Prevention magazine citation and also object to the nine examples we presented in the preamble to the CGMP Proposal see 68 FR at through We cited the Prevention magazine survey on consumer use of dietary supplements to show that only 41 percent of surveyed consumers who use vitamins and minerals think those products are very safe, and only 50 percent think the products are somewhat safe; among those using herbal products, only 24 percent thought the products were very safe, and only 53 percent thought the products were somewhat safe.

We noted that 74 percent supported increased government regulation of dietary supplements see, id. As one example of adulterated dietary supplements caused by manufacturing practices, the preamble to the CGMP Proposal mentioned an instance where a young woman suffered a life-threatening abnormal heart function that was traced to a mislabeled or contaminated dietary ingredient 68 FR at Another example involved recalls of super- and subpotent dietary supplements id. Comments objecting to the Prevention survey said it provided no rationale for why CGMP requirements are needed. Other comments said the nine examples we provided represent a failure to conform to an existing regulation and do not demonstrate a need for a new CGMP regulation for dietary supplements.

One comment disagrees that the CGMP requirements would prevent adverse reactions, as one example suggested in the preamble to the CGMP Proposal see 68 FR at because, the comment claims, most adverse reactions are not the result of manufacturing problems. The comment states identity testing is necessary in the final rule. Some comments say the risks cited in the justification for these regulations are hypothetical or theoretical and current statutory or regulatory authority is adequate.

Response We disagree, in most part, with the comments. We cited the Prevention survey to illustrate consumer perception and support for increased government involvement in dietary supplement regulation. We did not describe the survey as illustrating CGMP problems associated with dietary supplements.

We also disagree that the risks cited in the preamble to the CGMP Proposal are merely hypothetical or theoretical. We provided actual examples of failures in the manufacturing of products marketed as dietary supplements. The comments may have misunderstood what the CGMP requirements for dietary supplements are intended to accomplish.

A principal goal of the CGMP requirements is to have those who manufacture, package, label, or hold dietary supplements do so in a manner that ensures the quality of the Start Printed Page dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. It is the manufacturer who needs to establish procedures for its manufacturing operations to ensure, for example, the final product is produced according to its specifications in the master manufacturing record, meets limits on contaminants, and is a quality dietary supplement.

If a product does not meet its specifications, a manufacturer who observes the CGMP requirements should know that and be able to take corrective action before the dietary supplement enters the marketplace. The onus is on the manufacturer, and not simply on us, to take action to prevent the adulterated product from entering the market or, if the product has already been released, to remove the product from the market.

The examples we used in the preamble to the CGMP Proposal included adverse event reports associated with contamination with Digitalis lanata , the possible contamination of botanical ingredients with toxic compounds, the use of non-food grade chemicals, the manufacture of super- and subpotent dietary supplements, the presence of undeclared ingredients, and the variability of ingredients from what is declared on the label Refs.

These were all examples where products were manufactured, labeled, and sold to the consumer as dietary supplements. The dietary supplement CGMP requirements ensure adequate controls are in place to identify many of these types of manufacturing errors before the product is in the marketplace and not through postmarketing adverse event reports or consumers' illnesses.

The dietary supplement industry is diverse, as are the number and types of products marketed as dietary supplements. As we stated in the preamble to the CGMP Proposal 68 FR at , given the wide range of public health concerns presented by the manufacturing practices for dietary supplements, a comprehensive system of controls is necessary. This final rule will set the standards for CGMP for dietary supplements that, if followed, will help ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

The establishment of production and process controls and adherence to these and other CGMP requirements of this final rule will help to prevent the types of events and others we described in the nine examples presented in the preamble to the CGMP Proposal. Comment 6 Several comments suggest that dietary supplements are no different in safety or physiologic effect and require no different requirements than conventional food with respect to CGMP. One comment disagrees with us that dietary supplements require different requirements than conventional food because dietary supplements are ground up or in powder form and may not be easily recognized or differentiated; the comment says the same is true of many food ingredients as well.

Response We disagree with the suggestions by these comments that dietary supplement CGMP requirements need not differ from those for conventional foods. By definition, a dietary supplement is in a category of food separate and distinct from the category of conventional food. The definition of dietary supplement in section ff of the act, in part, essentially describes a dietary supplement as a type of food that differs from conventional food. The definition refers to section c 1 B i and c 1 B ii of the act 21 U.

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Congress included separate additional provisions under section of the act see section f and g of the act for when a dietary supplement may be adulterated. Congress considered that dietary supplements may warrant CGMP requirements that are different than those for conventional food. Although dietary supplements may include substances that are used as ingredients in conventional foods, the amounts consumed as a dietary supplement and as a conventional food product may not be the same and, in fact, may be more concentrated, and in higher amounts, when taken as a dietary supplement.

The forms in which dietary supplements are consumed differ e. The uses of dietary supplements also differ from use as conventional food. Consequently certain manufacturing practices considered to be a part of CGMP for dietary supplement manufacturing may not be necessary for all types of food.

We also stated that, to limit the burden to manufacturers, we were not proposing to require written procedures for all the requirements. We stated that if comments assert that written procedures are necessary, comments should include an explanation of why the requirement is necessary to prevent adulteration including how such a requirement would ensure the identity, purity, quality, strength, and composition of the dietary supplement. Conversely, if comments assert that written procedures are not necessary, we asked for an explanation of why and how, in the absence of the requirement, one can prevent adulteration and ensure the identity, purity, quality, strength, and composition of the dietary supplement.

Comment 7 Many comments stress the most critical aspect of a successful CGMP system is effective process control, which requires conducting key operations using written procedures. Several comments assert that written procedures are an important part of manufacturing operations to ensure uniform practices in production operations, from receiving through final operations.


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Several comments assert written procedures provide a sound basis for employee training and supervision. Several comments state that without a written training program, it is very likely that some employees may not receive sufficient training, or in some cases, any CGMP training at all.

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One comment specifically suggests that companies develop written procedures for the minimum CGMP training common to all departments. One comment points out that all well-recognized quality systems require establishment of written procedures to ensure consistent process control, and cites examples such as the International Organization for Standardization, the American National Standards Institute ANSI , and the Malcolm Baldridge National Quality Award criteria.

Other comments state that written procedures are necessary for the definition, operation, and documentation of a process control system, and that without such procedures it would be virtually impossible for any company, regardless of size, to consistently manufacture products that meet established requirements for identity, purity, quality, strength, and composition. The comments note that written procedures contain the necessary instructions for all employees to successfully execute their respective functions.


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Another comment supports a requirement for conducting key operations using written procedures and states that records document that operations were performed, but that written procedures show how the task is to be performed and at what frequency it should be performed. One comment states effective communication is essential to build quality into a process, and written procedures provide that throughout all levels of an organization. Many comments which present one or more of these general reasons for requiring written procedures also list operations that they believe should be conducted using written procedures.

The operations that one or more comments list as key operations are:. Many comments assert an effective process control system that includes extensive written procedures would justify a decreased testing burden with respect to the finished product. One comment suggests we exempt manufacturers from the requirement to test each finished batch of product if they have a qualified manufacturing process that meets certain basic criteria, including a requirement for written procedures for each stage of the process.

One comment notes it would be clearer to all parties if specific written procedures were listed as required and stresses the importance of having all companies know exactly what is procedurally expected of them. In addition to these general reasons for requiring that key operations be conducted using written procedures, several comments provide specific reasons for requiring that specific operations be conducted using written procedures. Another comment states utility areas such as effluent treatment, boilers, cooling towers, and water Start Printed Page treatment plants also should have documented procedures for cleaning in order to create a general awareness of cleanliness throughout the plant.

According to these comments, such procedures would provide us with a written record that is sufficient to evaluate the adequacy of the company's calibration procedures and would provide the necessary controls to meet the underlying intent of the rule. These comments assert that written procedures will lessen the risk that adulterated products will be produced. These comments claim that written procedures promote consistency, clearly lay out expectations for employees, facilitate training, and provide a reference for individuals in performing their job functions.

One comment states that written procedures for maintaining, cleaning, and sanitizing equipment are an industry standard. Another comment states written procedures are a critical element for ensuring consistent implementation of proper corrective action. Other comments state they do not support a requirement for written procedures for preparing the master manufacturing record; and one comment suggests such a written procedure is not necessary because the proposed regulations for preparing the master manufacturing record already delineate the requirements for what information must be included in the master manufacturing record.

Some comments emphasize written procedures would create a standard for testing of products or groups of products and establishing parameters for passing or failing products. Another comment states written procedures can improve quality and consistency in a manufacturing operation. Another comment states a company cannot be considered to be a CGMP operation without having written procedures for every product manufacturing activity, including holding and distributing. This comment states mixups and adulterations will be more likely to occur if there are no written procedures for control of storage locations, manner of storage, and container and storage location identification codes.

In response to our request for comment on whether written procedures should be required for complying with the proposed requirements for returned dietary supplements, one comment states written procedures should govern all return and salvage operations to create a standard for quarantine and salvage and to establish parameters for proper salvage conditions. Responding to our request for comment on whether written procedures should be required for complying with the proposed requirements for handling consumer complaints, some comments state written procedures will encourage companies to handle consumer complaints in a uniform manner.

One comment asserts written procedures should be required for handling consumer complaints because some complaints could relate to serious illness or injury. The comment states that written procedures would set out exactly what steps need to be taken when complaints are reviewed, and are the best way to ensure the essential information is captured. Response We agree with the comments that effective process control, using written procedures, is an important aspect of a successful CGMP program. We also agree requiring written procedures will help to ensure consistent practices in operations i.

We also agree that written procedures provide a sound basis for employee training and supervision, are an effective communication tool, and enable quality control personnel to carry out the responsibility to approve or reject all processes, specifications, controls, tests, and examinations, and deviations from or modifications to them. In addition, written procedures establish expectations for each covered operation so the operation does not proceed in an ad-hoc manner. Written procedures provide specific guidance if there is an unanticipated occurrence and, thus, can play a key role in ensuring a quality product, because actions to correct the unanticipated occurrence can take place swiftly and with confidence in the outcome.

This final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, and holding dietary supplements to ensure a quality Start Printed Page product. The operations required by this final rule must be conducted in a consistent manner, regardless of who is conducting an operation or when the operation is conducted.

As discussed in the following paragraphs, with a few exceptions, we are requiring that you establish and follow written procedures to fulfill the requirements for the operations covered by this final rule. The exceptions include final subpart A, which addresses the scope of the rule, rather than operations covered by the rule; final subparts E, H, and I, in which we conclude that a requirement for written procedures would be redundant to other requirements; and final subpart P, which establishes requirements for making and keeping records, rather than for conducting operations.

By establishing and following written procedures, you will focus your production and process control system on ensuring the quality of the finished product at each stage in the production process, rather than relying entirely on testing at the end of the process. Written procedures for personnel final subpart B. We believe that successful programs for process control are directly connected to appropriate training programs.

Employee training must be conducted in a consistent manner, regardless of who conducts the training or when it is conducted. Failure to conduct employee training in a consistent manner could lead to a failure in ensuring product quality. For example, an employee who has not received appropriate training on how to conduct a specific physical examination to verify the identity of a dietary ingredient may erroneously report that the correct ingredient was received when, in fact, the received dietary ingredient is related to, but different from, the ingredient that is specified in the master manufacturing record.

We also believe the requirements that apply to preventing microbial contamination due to sick or infected personnel and that apply to proper hygienic practices must be conducted in a consistent manner. For example, it is well known that foodborne illness can be transmitted by workers who are sick. For example, volunteer food workers at an outdoor music festival were found to be the source of contamination for an outbreak of Shigellosis Ref. Written procedures for cleaning the physical plant, including pest control final subpart C. We agree with the comments that written procedures for cleaning the physical plant would reduce the potential for cross-contamination and that such written procedures must include written procedures for pest control.

Cleaning operations and pest control must be conducted in a consistent manner, regardless of who conducts the operation or when it is conducted. Failure to conduct cleaning operations and pest control in a consistent manner could lead to failure in ensuring product quality. For example, application of a chemical such as a fumigating agent or rodenticide in a production area must be performed correctly to avoid contaminating dietary supplements.

Therefore, we disagree that written procedures would not directly prevent contamination or ensure the identity, purity, strength, and composition of the dietary supplement even if a manufacturer maintains the physical plant in a clean and sanitary condition. Written procedures for calibrating instruments and controls and for calibrating, inspecting, and checking automated, mechanical, or electronic equipment final subpart D.

Calibrating instruments and controls, and calibrating, inspecting, and checking automated, mechanical, or electronic equipment must be conducted in a consistent manner, regardless of who conducts the operation or when it is conducted. Without a consistent approach, the performance of these operations could lead to equipment that produces inaccurate results.

For example, if a scale is out of calibration, the wrong amounts of components could be added to a mixer. We note that the manufacturers of equipment often provide written procedures for calibrating equipment. Depending on your circumstances and applications, you may be able to rely on written procedures provided by the manufacturer of the equipment with little or no modification.

Written procedures for maintaining, cleaning, and sanitizing equipment and utensils final subpart D. Maintaining, cleaning, and sanitizing equipment and utensils must be conducted in a consistent and appropriate manner, regardless of who conducts the operation or when it is conducted. Failure to clean and sanitize equipment and utensils in a consistent and appropriate manner could lead to a product that is adulterated because, for example, equipment and utensils that are not properly cleaned and sanitized could be a source of microorganisms, or could lead to cross-contamination of products.

In addition, failure to maintain equipment in a consistent manner could lead to the failure to ensure product quality. For example, equipment that is properly maintained is less likely to malfunction than equipment that is not maintained, and using equipment that malfunctions could lead to errors in production, such as dispensing an incorrect amount of each ingredient.

Although the factors you must consider for maintaining, cleaning, and sanitizing equipment used for labeling operations likely are different from those for equipment used in manufacturing or packaging operations, you nevertheless must determine the appropriate steps to take to ensure that labeling equipment is appropriately maintained and does not become a source of contamination Start Printed Page for dietary supplements.

For example, equipment used for labeling operations has a greater potential to contaminate a dietary supplement when labeling operations are carried out in concert with packaging operations, because the dietary supplement could be exposed to one or more contact surfaces during the packaging operations.

Comment 8 Some comments suggest that written procedures for maintaining, cleaning, and sanitizing equipment require visual inspection of equipment when more than one product is manufactured using the same equipment, and that the presence of residual components from one product in a different product could be harmful. The comments also suggest the written procedures include residual limits of components from different product lines to guarantee the safety of the dietary supplement. Response The final rule gives you flexibility to develop written procedures appropriate to your products and equipment.

As for the residual limits, the comment provides no data or other information that would provide a basis for setting residual limits for any particular components. When considering the specifications you must establish to ensure the quality of the dietary supplements, you must take into account the need to ensure that components or dietary supplements are not contaminated as a result of using the same equipment. Written procedures for quality control operations, including written procedures for conducting a material review and making a disposition decision and written procedures for approving or rejecting reprocessing final subpart F.

Quality control operations must be conducted in a consistent manner. Failure to carry out quality control operations in a consistent and appropriate way could lead to failure to ensure product quality and to ensure the dietary supplement is packaged and labeled as specified in the master manufacturing record.

For example, you could use a component that should not have been released for use in manufacturing, or you could distribute a packaged and labeled dietary supplement that should not have been released for distribution. We agree with the comments that there should be written procedures for investigating failures in manufacturing operations.

The review must be conducted in a consistent manner, and the criteria for making a disposition decision must be consistent, regardless of who is conducting the material review or when it is conducted, and regardless of who makes the disposition decision and when the decision is made.

For example, if you do not have written criteria for determining whether a deviation from specifications has resulted in, or could lead to, adulteration, different individuals who conduct a material review could reach different decisions regarding the appropriate disposition of the affected dietary supplement, including decisions that incorrectly result in the release of an adulterated product.

As discussed more fully in sections X and XI of this document, the final rule requires that quality control personnel conduct all required material reviews and make all required disposition decisions. We considered the comments that suggest that there should be a requirement for you to establish and follow written procedures for reprocessing from two perspectives: 1 Determining whether reprocessing should be approved or rejected and 2 performing the reprocessing. In general, reprocessing is performed when there is a problem with the manufacturing process, such as when a specification is not met or any step in the master manufacturing record is omitted.

Depending on the nature of the dietary supplement, the manufacturing process, and the problem, reprocessing may or may not be able to correct the problem. The decision to approve reprocessing must be made in a consistent manner, regardless of who conducts the operation or when it is conducted. For example, if it is not possible to test the product at the finished batch stage to determine whether the reprocessing corrected the problem because, for example, there is no scientifically valid method available to test for a specification that is directly related to the reason for reprocessing , you must have a clear basis to decide that reprocessing will actually correct the problem or you will not know if all required specifications can be met.

Without written procedures for approving reprocessing, different individuals who approve or reject any reprocessing could make very different decisions on when reprocessing can correct a problem and when it cannot. Therefore, we are specifically requiring that the written procedures for quality control operations include written procedures for approving or rejecting any reprocessing.

From the perspective of performing the reprocessing, we agree that any procedure for reprocessing must be written because, for example, quality control personnel may need to rely on the procedure that you followed to determine whether all specifications are met for the reprocessed material. Written procedures for components, packaging, labels, and product that is received for packaging and labeling as a dietary supplement final subpart G. We agree with the comments that the Start Printed Page receipt, examination, quarantine, and release from quarantine of components, packaging, labels, and product that are received for packaging and labeling as dietary supplements must be conducted in a consistent manner, regardless of who conducts the operation or when it is conducted.

Failure to carry out these operations in a consistent way could lead to failure to ensure product quality if, for example, you use a component that should not have been released for use in manufacturing. Written procedures for laboratory operations final subpart J. Testing and examination of components, packaging, labels, and product that are received for packaging or labeling as a dietary supplement, or packaged and labeled dietary supplements, must be conducted in a consistent manner, regardless of who conducts the operation or when it is conducted. The reason a firm conducts these tests and examinations is to ensure that a dietary supplement meets established specifications.

Failure to conduct tests and examinations in a consistent manner could lead to failure in ensuring the quality of the dietary supplement. For example, a test designed to determine the concentration of a product before it is diluted to the appropriate concentration could provide different results if it is conducted in a different manner by different individuals. In addition, laboratory operations such as use of criteria for establishing appropriate specifications and use of sampling plans for obtaining representative samples must be conducted in a consistent manner, regardless of who conducts the operation or when it is conducted.

For example, failure to consider that specifications are needed to ensure that a dietary supplement derived from a botanical source does not contain contaminants, such as an unlawful pesticide, could result in a dietary supplement that contains unsafe levels of a contaminant. Written procedures for manufacturing operations final subpart K. We agree with the comments that written procedures for manufacturing operations would be an effective way to train personnel, provide a means to hold operators accountable to a quality standard, and improve quality and consistency in a manufacturing operation.

The final provisions for manufacturing operations require you to design or select manufacturing processes to ensure that dietary supplement specifications are consistently achieved, conduct all manufacturing operations in accordance with adequate sanitation principles, and take all necessary precautions to prevent contamination of components and dietary supplements. These manufacturing operations must be conducted in a consistent manner, regardless of who conducts the operation or when it is conducted. Failure to perform these operations in a consistent way could lead to failure to ensure the quality of the dietary supplement.

For example, surfaces that come in contact with a dietary supplement are potential sources of microbial contamination if consistent procedures are not in place to ensure good sanitary practices. Written procedures for packaging and labeling operations final subpart L. We agree with the comments that written procedures for packaging and labeling operations are an effective means to hold operators accountable to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

The final provisions for packaging and labeling operations require that you fill, assemble, package, label, and perform other related operations in a way that ensures the quality of the finished product, including practices such as cleaning and sanitizing all filling and packaging equipment, utensils, and containers; protecting manufactured dietary supplements against airborne contamination, using sanitary handling procedures; taking actions to prevent mixups; and suitably disposing of obsolete packaging and labels.

These packaging and labeling operations must be conducted in a consistent manner, regardless of who conducts the operation or when it is conducted. Failure to perform these operations in a consistent way could lead to a failure to ensure the quality of the dietary supplement and that the dietary supplement is labeled and packaged as specified in the master manufacturing record. For example, if you do not have procedures for identifying filled, but unlabeled, containers of dietary supplements, mixups could occur before the labels are applied.

The final product could contain ingredients other than those identified on the label specified in the master manufacturing record. Written procedures for holding and distributing operations final subpart M. We agree with the comments that written procedures for holding and distributing operations are an effective means to hold operators accountable to CGMP standards, and that mixups and other problems that affect the final product will be more likely to occur if there are no written procedures for operations such as control of storage locations, manner of storage, and container and storage location identification codes.

The final provisions for holding and distributing operations require, among other things, that you hold components and dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the components and dietary supplements are not affected; that you hold components, dietary supplements, and in-process materials under conditions that do not lead to the mixup, contamination, or deterioration of components or dietary supplements; and that you distribute dietary supplements under conditions that will protect them against contamination and deterioration.

These holding and distributing operations must be conducted in a consistent manner, regardless of who conducts the operation or when it is conducted. Failure to follow these requirements for holding and distributing in a consistent manner could lead to a failure to ensure the quality of the dietary supplement product.

For example, if employees do not know how to store an in-process batch of a botanical dietary supplement to control humidity, the growth of mold could be promoted. Furthermore, if a distributor does not refrigerate a dietary supplement that requires refrigeration to ensure its strength, the dietary supplement may not meet its specification for strength. Written procedures for returned dietary supplements final subpart N.

We agree with the comments that written procedures for returned dietary supplements would help to ensure appropriate handling of such supplements prior to a disposition decision. The final rule requires you, among other things, to identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a disposition decision. You must destroy, or otherwise suitably dispose of, any returned dietary supplement that quality control personnel do not approve for salvage or reprocessing.

These operations for returned dietary supplements must be conducted in a consistent manner, regardless of who conducts the operation or when it is conducted. Failure to comply with these requirements for quarantine, salvage, and disposition in a consistent way could lead to a failure to ensure the quality of the dietary supplement.

For example, if an investigation leads to a conclusion that a dietary supplement requiring refrigeration to ensure its strength was not refrigerated while held at a customer's warehouse, and this dietary supplement was not quarantined while quality control personnel conducted a material review, the dietary supplement could be inadvertently co-mixed with other containers of that same lot of product and then inadvertently redistributed. Written procedures for product complaints final subpart O.

We agree with the comments that written procedures for handling consumer complaints now called product complaints will encourage companies to handle product complaints in a consistent manner and help ensure the essential information is captured during investigation of a product complaint.

The final rule requires you, among other things, to review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications; investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications; and extend the review and investigation of the product complaint to all relevant batches and records. These operations must be conducted in a consistent manner, regardless of who conducts the operation or when it is conducted.

Failure to comply with these requirements for review and investigation of a product complaint in a consistent way could lead to a failure to ensure the quality of the dietary supplement. For example, if you do not have a procedure in place to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, you may not recognize that a particular product complaint is indicative that a problem has occurred with one of your manufacturing processes.

That undiscovered problem may lead to continued distribution of product that is contaminated or otherwise not consistent with your specifications in the master manufacturing record. Given the strong support in the comments for the use of written procedures in a production and process control system, we nonetheless considered whether the requirements that we establish in final subpart E, Requirement to Establish a Production and Process Control System , would require written procedures.

In considering whether we should require that you establish and follow written procedures to fulfill the requirements of final subpart E, we evaluated whether requirements in other subparts that address specific operations for the production and process control system substitute for the requirement of written procedures in final subpart E. Final subparts F through M establish specific requirements for manufacturing, packaging, labeling, and holding dietary supplements, including requirements for quality control operations final subpart F ; components, packaging, labels, and product that is received for packaging and labeling as a dietary supplement final subpart G ; establishing a written master manufacturing record and batch record final subparts H and I ; laboratory operations final subpart J ; manufacturing operations final subpart K ; packaging and labeling operations final subpart L ; and holding operations final subpart M.

We require you to establish and follow written procedures to fulfill the requirements of final subparts F, G, J, K, L, and M. Final subpart M establishes requirements for holding reserve samples. We conclude that it would be redundant to require you to establish and follow written procedures for each of the requirements established in final subpart E. We, therefore, do not require you to establish and follow written procedures to fulfill the requirements established in subpart E.

Written procedures for preparing the master manufacturing record final subpart H and for preparing the batch record final subpart I. As discussed in the CGMP Proposal 68 FR at , a master manufacturing record is analogous to a recipe that sets forth the ingredients to use, the amounts of ingredients to use, the tests to perform, and the instructions for preparing the quantity the recipe calls for. This master manufacturing record helps ensure that you manufacture each ingredient or dietary supplement in a consistent and uniform manner.

If you neglect to follow the master manufacturing record, you might not add all of the necessary components in the appropriate strength or amount, and this could result in a final product not consistent with the master manufacturing record. Thus, you must follow a written master manufacturing record in a consistent manner, regardless of who conducts the operation or when it is conducted.

However, we agree with the comments that the specific requirements for what must be in the master manufacturing record make it unnecessary to require written procedures for preparing the master manufacturing record. Under final subpart H, the master manufacturing record must include written instructions, including specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; procedures for sampling, testing, and examinations; specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; special notations and precautions to be followed; and corrective action plans for use when a specification is not met.

With all of this detail specified for the written instructions the master manufacturing record must include, we believe a written procedure for developing a master manufacturing record can be optional. Therefore, we do not require you to establish and follow written procedures for preparing the master manufacturing record. A batch is prepared by following the written instructions provided in the master manufacturing record. The master manufacturing record functions as a written procedure for the production of the batch.

Therefore, we do not require you to establish and follow written procedures for the batch production record because such practices would be redundant to the requirements for the master manufacturing record in final subpart H. Written procedures for records and recordkeeping final subpart P. Final subpart P establishes general requirements for making and keeping records required in other subparts.

We did not request comments on written procedures, nor did we receive any comments that supported such a requirement. Because we believe that requiring written procedures to fulfill subpart P requirements would be redundant or unnecessary, we do not require such written procedures. Written procedures for product recalls. We acknowledge that a product recall by persons who manufacture, package, label, or hold dietary supplements must be conducted in a consistent manner, regardless of who conducts the operation or when it is conducted. However, the final rule does not establish any requirements for product recalls.

Therefore, we do not require you to establish and follow written procedures for product recalls. Comment 9 One comment stresses the need for flexibility in requiring written procedures, based on differences between individual activities and companies.

Electronic Components, Technology and Materials

The comment suggests companies should be required to review and determine the need for written procedures at each critical step of their operations and be prepared to defend those determinations as necessary. Response To the extent the comment suggests we do not require any written procedures specific to a particular function or requirement, and allow firms to decide when and when not to include them, we disagree.

We believe that written procedures for the specific operations we have identified should not be optional. We have no objection if firms decide to establish and follow additional written procedures, beyond those we require in this final rule. Although we require written procedures for entire subparts, or specific requirements within certain subparts, we provide flexibility for firms to establish those written procedures that will ensure the requirements are met.


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  7. Comment 10 Some comments stress the importance of written procedures in enabling FDA to ensure compliance with the dietary supplement CGMP requirements. Response We believe written procedures will help us to ensure compliance with these CGMP requirements because they will clearly communicate the steps the firm must take to satisfy the requirements.

    During an inspection, we observe the practices that employees follow. However, to ensure that a firm is consistently complying with CGMP requirements, our investigators need access to records that both describe a firm's processes and procedures and demonstrate whether the firm has been following them. Under the final rule, we require you to make and keep records of the written procedures in each applicable subpart. Such records would be available to us under the requirements of final subpart P, Records and Recordkeeping. Comment 11 Many comments object to FDA's stated reasons for not requiring written procedures for most activities, including concerns about cost control and burden reduction.

    The comments contend that written procedures Start Printed Page actually save time and other resources because they greatly facilitate employee training and ensure that activities are performed consistently and correctly. Some comments assert most companies already have written procedures in place, so start-up costs associated with such requirements would be minimal. One comment notes written procedures would be among the least costly of all the procedural requirements proposed by FDA.

    Response We agree that requiring that operations be conducted using written procedures can save time and other resources by facilitating employee training and ensuring operations are performed consistently and correctly. Because following written procedures can help ensure uniformity in the process and ensure the quality of the dietary supplement at every step, periodic end product testing can be sufficient to determine whether your manufacturing process is controlled.

    CGMP is premised upon quality assurance at every step of the process. It is less costly to establish and follow written procedures than it would be to test each finished batch for conformance with specifications. As suggested by these comments, our analysis section XXIV of this document shows that the overall costs are reduced, in part, because requiring that certain operations be conducted using written procedures enables us to reduce requirements for testing at the finished batch stage.

    Comment 12 One comment states training employees on the required hygienic practices prior to their first day of handling product is critical to ensuring product safety. Response The requirement to establish and follow written procedures to fulfill the requirements of subpart B does not establish any fixed requirement for when an employee must receive such training relative to when the employee handles product.

    We therefore assume that employees will have the necessary education, training, or experience for each operation that they perform before they perform it. Comment 13 Some comments make recommendations for what written procedures should contain, including general parameters that should be included in all written procedures and specific parameters that should be included in specific written procedures.

    The general parameters include identification of the company; title that reflects the activities to be performed; identification or control number with a revision level code; effective date; the number of pages in the procedure e. In the specific case of written procedures for cleaning equipment and utensils, some comments suggest the written procedures include descriptions of appropriate cleaning agents, methods of cleaning, and the intervals and schedules for cleaning equipment.

    Response We agree the suggestions provided by these comments are useful to include in any written procedures. However, to provide the flexibility necessary to address diverse dietary supplement manufacturing processes, we are leaving details such as these to the judgment of the company rather than prescribing them within the final rule.

    Comment 14 Some comments request the final rule include requirements for managing changes to written procedures. One comment states changes to written procedures should be reviewed, justified, documented, approved, and implemented in a defined manner. Response As discussed in final subpart F, the final rule requires that quality control personnel approve all written procedures. As discussed in this section, the final rule requires you to establish and follow written procedures for quality control operations. We believe that procedures for managing changes to written procedures can be addressed within the written procedures for quality control operations.

    Comment 15 Some comments assert the final rule should not require written procedures for key operations because the rule should stay focused on end results and not process. Response We disagree. The essence of good manufacturing practice that is established by this final rule is a production and process control system that is designed to ensure the quality of the dietary supplement.

    We address SBREFA's regulatory flexibility issues by staggering compliance dates so that certain businesses would have 24 and 36 months, respectively, to comply with the final rule. The industry draft that we published in the ANPRM had multiple written procedures, including written procedures for:. Although this issue arose as a discussion of regulatory options that we had considered and rejected, we received several comments on this subject.

    Some comments state we should not create different CGMP standards based upon the type of dietary ingredient. These comments state that one set of appropriately flexible standards would be more efficient and less confusing to industry than separate standards for each portion of the industry. Other comments supported the concept of differing standards. Some comments assert, in order for the CGMP regulations to set minimum quality standards for all dietary supplements, we would have to regulate each facet of the manufacture, packaging, and storage of a dietary supplement independently of product type.

    These comments state reducing the requirements for vitamin and mineral manufacturers would not allow the development of minimum quality standards across the entire dietary supplement industry. Response The concept of fewer requirements for vitamins and minerals was simply one regulatory option we considered as part of the CGMP Proposal's analysis of impacts see 68 FR at through We rejected it id.

    We disagree with the comments that there should be fewer CGMP requirements for vitamins and minerals. Neither the CGMP Proposal, nor this final rule, imposes fewer requirements on vitamin or mineral firms compared to firms that make other types of dietary supplements. Many comments were submitted from individuals, companies, and trade groups concerning our legal authority for this rule.

    Most of the comments question the scope of the rule based on the language in section g of the act 21 U. Some comments assert that certain provisions of the proposed rule are unconstitutionally vague, and therefore violate the Fifth Amendment. A few comments disagree with our rationale for why dietary supplements are different than conventional food and need separate CGMP requirements. We address these comments immediately below in this section. Comment 18 Some comments support our approach of proposing requirements that are more comprehensive than the CGMP requirements for food.

    Several comments state that the requirements for dietary supplement CGMP do not need to be identical to the requirements in existing food CGMP regulations, that appropriate manufacturing controls are needed for dietary ingredients contained in dietary supplements to protect the public health, that some borrowing of drug CGMP concepts may be necessary, and that we should balance effective control with necessary flexibility in the dietary supplement CGMP rule.

    IEEE Transactions on Components Packaging and Manufacturing Technology

    Several comments express concern about not deviating too drastically from the requirements in existing food CGMP regulations. Although several comments recognize that additional CGMP provisions for dietary supplements, such as those related to identity, purity, strength, quality, and composition, are needed, the comments say that we should not regulate dietary supplement manufacturing in the same manner as drug manufacturing because it would entail overly burdensome methods for production and process controls.

    Some comments contend that some of the proposed rule requirements exceed the drug CGMP requirements. The reasons for this assertion vary. Some assert that certain provisions in the proposed rule were not found in, or differ from, the provisions in part Examples of proposed requirements that comments indicate exceeded food CGMP included batch testing, packaging and labeling, recordkeeping, consumer complaints, and the use of validated methods.

    Other comments state that the proposed requirements exceeded those for food because the proposed rule provided for finished testing of certain substances when used as dietary supplements, such as garlic and ginger, whereas no such testing is required under existing food CGMP regulations when those same substances are used as conventional food.

    Some comments assert that the proposed requirements exceed the existing food CGMP regulations because certain proposed provisions contained a level of detail that is not in the food or the drug CGMP regulations, or because elements of a provision in the proposed rule were similar to a provision in part 21 CFR part drug CGMP regulation.

    Other comments disagree with our rationale that the proposed rule was designed on the same principles as the existing food CGMP regulations to address the characteristics and hazards specific to dietary supplements, or to prevent adulteration in preparing, packaging, or holding dietary supplements. Natural Resources Defense Council , U. One comment states that, even if the language is ambiguous and our interpretation merits deference, our interpretation is too expansive and not based on a permissible construction of the statute. Another comment states that we did not explain why our interpretation was consistent with our congressional mandate.

    Response We agree with the comments stating that the dietary supplement CGMP requirements in this final rule need not be identical to the existing food CGMP regulations and that a system of manufacturing controls specific to dietary supplements is needed. We do not agree that we exceeded the scope of our authority under section g of the act in issuing the proposed requirements for dietary supplement CGMP or these final requirements.

    First, has Congress directly and unambiguously spoken to the precise question at issue? To find no ambiguity, Congress must have clearly manifested its intention with respect to the particular issue see Young v. Community Nutrition Institute , U. If Congress has spoken directly and plainly, we must implement Congress's unambiguously expressed intent see Chevron , U. Congress has also spoken to the precise question of whether the dietary supplement CGMP requirements must be identical to the requirements in existing food CGMP regulations. Indeed, if Congress had intended for CGMPs for dietary supplements to be the same as food CGMPs, there would have been no need for Congress to have addressed the issue at all; as a type of food, dietary supplements would otherwise be governed by the food CGMPs.

    See section ff of the act 21 U. Thus, the additional, independent authority to promulgate CGMP regulations for dietary supplements that Congress provided in section g of the act, without delineating what requirements such a regulation could or could not include, left us with considerable authority to fill in the gaps in ways that recognize the differences between dietary supplements and other foods that warrant different manufacturing controls. Thus, it is Start Printed Page consistent with our statutory authority for us to look to all of our food CGMP regulations—including infant formula, low-acid canned foods, acidified foods, and bottled water, as well as our general food CGMP regulations—after which to model our dietary supplement CGMP regulations.

    Given this ambiguity, therefore, under Chevron step two, we may determine what requirements to include in this final rule for dietary supplement CGMP, provided that our interpretation is not arbitrary, capricious, or manifestly contrary to the statute Chevron , U. Accordingly, we considered the types of requirements in the existing food CGMP regulations and used those as models for the dietary supplement CGMP requirements.

    We considered both the objectives and the means of achieving the objectives in the existing food CGMP regulations.

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    Just as the precise requirements of the other food CGMP regulations are tailored to the particular characteristics and hazards of the foods and manufacturing processes being addressed, the dietary supplement CGMP requirements are also so tailored. The infant formula CGMP regulation also includes numerous requirements that manufacturers maintain records, e. For example, like the infant formula regulation, the dietary supplement CGMP regulation is designed to establish a quality control system to make sure that dietary supplements are properly manufactured. Promulgated primarily under the adulteration provisions of section a 3 and a 4 of the act, as well as section of the Public Health Service Act the PHS Act 42 U.

    The detailed requirements of the umbrella food CGMP regulation accomplish these objectives through a variety of means. Because of the particular hazards associated with low-acid canned foods and with acidified foods, the CGMP regulations for these foods contain detailed provisions to ensure safe manufacturing.

    Functions of Pharmaceutical Packaging

    Specifically, the CGMP regulations for these foods protect the public health against microbial contamination from these foods. Part sets out safe manufacturing, processing, and packaging procedures for low-acid foods in hermetically sealed containers.