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Mastering Part 211 Subpart E: Control of Components & Containers

Updated: Feb 15


In drug manufacturing, the quality of components and containers and closures used to store drug products is crucial. The FDA has established regulations under Part 211 Subpart E of the Code of Federal Regulations (CFR) to ensure that the components used in drug manufacturing, as well as the containers and closures used to store the final drug product, are of high quality and meet the required standards. In this blog, we will explore how to implement the requirements of Part 211 Subpart E in drug manufacturing.

In drug manufacturing, the quality of components and containers and closures used to store drug products is crucial. The FDA has established regulations under Part 211 Subpart E of the Code of Federal Regulations (CFR) to ensure that the components used in drug manufacturing, as well as the containers and closures used to store the final drug product, are of high quality and meet the required standards. In this blog, we will explore how to implement the requirements of Part 211 Subpart E in drug manufacturing.


Requirements of Part 211 Subpart E


Part 211 Subpart E outlines the requirements for the control of components used in drug manufacturing, as well as the containers and closures used to store the final drug product. The regulation requires that all components, containers, and closures used in drug manufacturing be tested and evaluated for quality before they are used in the manufacturing process. This evaluation includes both physical and chemical testing, as well as visual inspection, to ensure that the components and containers meet the required specifications.

The regulation also requires that manufacturers maintain records of all testing and evaluation of components and containers, as well as records of any deviations from established specifications. These records must be maintained for a period of time specified by the regulation, and must be made available to the FDA upon request.


In addition to testing and evaluation, the regulation requires that manufacturers have a system in place to prevent mix-ups, contamination, and other errors in the handling and storage of components and containers. This system should include procedures for the proper identification, storage, and handling of components and containers, as well as procedures for the disposal of any components or containers that do not meet the required specifications.


Implementing Part 211 Subpart E


To implement the requirements of Part 211 Subpart E, manufacturers should develop a comprehensive quality management system that covers all aspects of component and container control. This system should include procedures for the testing and evaluation of components and containers, as well as procedures for the proper identification, storage, handling, and disposal of these materials.


Testing and Evaluation of Components and Containers


The first step in implementing Part 211 Subpart E is to establish procedures for the testing and evaluation of components and containers. These procedures should cover both physical and chemical testing, as well as visual inspection, to ensure that the materials meet the required specifications.


Physical testing may include tests for size, shape, weight, and other physical characteristics of the components and containers. Chemical testing may include tests for purity, strength, and other chemical properties of the components and containers. Visual inspection may include checks for defects, such as cracks, chips, or other imperfections, that could compromise the integrity of the components and containers.


Once the testing and evaluation is complete, manufacturers should maintain records of all testing and evaluation results, as well as any deviations from established specifications. These records should be maintained for the required period of time, and should be made available to the FDA upon request.


Preventing Mix-Ups and Contamination


In addition to testing and evaluation, manufacturers should also establish procedures for the proper handling, storage, and disposal of components and containers. These procedures should be designed to prevent mix-ups, contamination, and other errors in the handling and storage of these materials.


Procedures for the proper identification, storage, and handling of components and containers should include clear labeling of all materials, and procedures for the proper storage and handling of each material. Manufacturers should also establish procedures for the disposal of any components or containers that do not meet the required specifications, to prevent these materials from being used in the manufacturing process.


Training and Documentation


To ensure that the requirements of Part 211 Subpart E are properly implemented, manufacturers should also establish a comprehensive training program for all personnel involved in the handling and storage of components and containers. This program should cover all aspects of component and container control, including procedures for testing and evaluation, proper identification and labeling, and storage and handling procedures. The training program should also include procedures for the disposal of any materials that do not meet the required specifications.


To document compliance with Part 211 Subpart E, manufacturers should maintain detailed records of all testing and evaluation, as well as records of any deviations from established specifications. These records should be maintained for the required period of time, and should be made available to the FDA upon request.


Continuous Improvement


Finally, to ensure ongoing compliance with Part 211 Subpart E, manufacturers should establish a program of continuous improvement. This program should include regular audits of the quality management system, as well as ongoing monitoring of all component and container control procedures.


During these audits and monitoring activities, manufacturers should look for opportunities to improve their procedures, and to identify any areas where the system may be improved. This may include revising procedures for testing and evaluation, improving storage and handling procedures, or implementing new technologies or materials that may improve the quality of the final drug product.



The requirements of Part 211 Subpart E are essential for ensuring the quality of components and containers used in drug manufacturing. To implement these requirements, manufacturers must establish a comprehensive quality management system that covers all aspects of component and container control, including testing and evaluation, proper identification and labeling, storage and handling procedures, and procedures for the disposal of any materials that do not meet the required specifications.


Contact  BioBoston Consulting today or visit our  website to learn more about how we can support your organization.


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