Explore the requirements of Part 211 Subpart E for drug manufacturing, including component and container control, testing, compliance, and strategies for continuous improvement.
Quality of drug substances and, containers: The containers that should be used for packing ofdrugs must be aseptic. We must make sure the components employed in producing a drug and for storing the final drug product meets L standards required by regulations per 21 CFR Part 211 Subpart E “CONTROL OF COMPONENTS USED IN MANUFACTURING.. This article will draw on the triggers provided in 211 subpart E to relevance them to drug manufacturing.
Compliance with Part 211 Subpart E
Part 211 Subpart E describes the requirements for control of components used in drug production, and also for containers and closures prepared to store the final drug product. This regulation mandates before using any component, container or closure used in manufacturing drug shall be tested and evaluated for quality. It covers physical, chemical and visual tests of the components and containers to ensure that they comply with the specifications required.
The rule also mandates that manufacturers retain records of all component and container testing and evaluations, as well as records of any variance from established specifications. Such records must be kept for a period of time as required by the regulation and they must be made available to FDA on request.
The regulation also mandates manufacturers to have a system in place that would prevent any mix-ups, contamination, or other errors associated with the components and containers during their handling and storage. The system shall be procedures for the correct identification, storage and handling of components and containers, along with a way to discard any components and/or containers that does not meet w/t requirements.
The Process for Subpart E
Manufacturers should establish a comprehensive quality management system addressing all aspects of component and container control for the purposes of compliance with the requirements of Part 211 Subpart E. The system includes test and evaluation procedures for components and containers as well as identification, storage, handling and disposal of these materials.
Component and Container Testing and Evaluation
The initial step in execution Part 211 Subpart E is the arrangement of systems for testing and assessment of segments and compartments. You should have procedures that include physical and chemical testing, e.g., visual inspection to determine if the materials meet the necessary specifications.
Physical testing may include size, shape, weight or other physical attributes of components and containers. Purity, strength and other chemical properties of components and containers may need to be tested via test for chemical testing. The visual inspection should confirm no cracks, chips or other defects that could make the component and container not worthy of use.
Upon the completion of testing and evaluation, all results plus any deviations from established specifications should be recorded by manufacturers. These records should be retained for the required time and provided to the FDA on demand.
Avoiding Tangles and Cross-Contamination
In addition to testing and evaluation, vendors should also define procedures for the proper handling, storage and disposal of components and containers. Such procedures must prevent any confusion, cross-contamination and mixing of real material and protect it from damage during production, or in transit.
Processes for appropriate identification labels on items and containers, and processes shown to include correct storage area and management per item. Manufacturers should also establish procedures to dispose of any materials/components/containers that do not meet the required specifications and should not be used in the manufacturing process.
Training and Documentation
Manufacturers should also maintain a robust training scheme for handling and storage of parts and the containers, properly train personnel in order to comply with Part 211 Subpart E. This program should be all-inclusive as to component and container control, procedures for testing and evaluation, correct identification and labeling, storage and handling procedures. The coaching also needs to encompass strategies to get rid of materials that do not meet your requirements.
For the record, to show compliance with Part 211 Subpart E, manufactures must have specific records of all testing and examination they perform, as well as documentation any deviation from standard specifications. Each of these records must be kept for the required time period and be available upon appropriate request.
Continuous Improvement
A continuous improvement program is essential for manufacturers to ensure they remain in compliance with 21 CFR Part 211 Subpart E. This shall be through a program which provides for regular audits of the quality management system, at intervals not exceeding one year, as well as on-going verification that all component and container control procedures under 21 CFR part 211 are being followed.
Manufacturers should use these audits and monitoring activities to look for ways to develop their processes further and areas for improvement to make the system powerful. This could be anything from re-writing testing and evaluation procedures, updating storage or handling practices, incorporating different technologies (including new materials) which can help to enhance the quality of the final drug product.
Conclusion
Part 211 Subpart E requirements are necessary to ensure the quality of the components and containers used in the manufacturing process of a medicinal product. In order to manage all these requirements, manufacturers shall maintain a quality management system that includes control of components and containers through appropriate testing, evaluation and supply activities, identification, Labeling, storage procedures and procedures for rejecting goods not meeting specifications.
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