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- Pharma Manufacturing Recruitment in 2013—and Beyond
- PDA Comments on Draft Regulation—The Impact is Clear
- Risk and Statistics Serve as Tools for Solving Variation Riddles and Creating Robust Processes
- Will FDA Combo Rule Help Pharma with Quality Systems?
- PDA Metro Chapter Learns the Fine Art of Investigations
June PDA Letter
Our second podcast is now available! Listen to Mark Sebree discuss his company's plans to develop generic injectables using prefilled syringes.
Free Articles to All PDA Members and Non-Members.
Should Scientific Data Determine Cytotoxic Limits?
Over the past few years, regulatory bodies have explored the issue of exposure limits during the manufacture of cytotoxic drugs in multipurpose facilities. A recent draft EMA guideline and the proposed revisions to chapters 3 and 5 of the EU GMPs appear to propose the use of toxicological data along with some rather stringent and apparently not scientifically based criteria to determine exposure limits when working with potent/highly potent drugs.
Over the past few years, regulatory bodies have explored the issue of exposure limits during the manufacture of cytotoxic drugs in multipurpose facilities. A recent draft EMA guideline and the proposed revisions to chapters 3 and 5 of the EU GMPs appear to propose the use of toxicological data along with some rather stringent and apparently not scientifically based criteria to determine exposure limits when working with potent/highly potent drugs.
Important Considerations for Aseptic Processing Validation
The key to successful validation of the sterility of aseptic processing lies in the analysis of a number of core considerations. For the uninitiated, aseptic processing validation is the complete set of key validations, such as component sterilization, cleaning, disinfection, HVAC systems, water systems, operator training, environmental controls, and others which together contribute to the aseptic process. An essential element is the process simulation (media fill tests) which is a required tool to demonstrate the effectiveness of contamination control. While manufacturers of aseptically processed materials can label their product to be sterile, the very nature of aseptic processing is not a guarantee of sterility, only achievement of meeting validated criteria of the aseptic process. Knowing this, terminal sterilization can be attributed to a sterility assurance level, while aseptic processing incorporates further controls to reduce risk to the end user.
The key to successful validation of the sterility of aseptic processing lies in the analysis of a number of core considerations. For the uninitiated, aseptic processing validation is the complete set of key validations, such as component sterilization, cleaning, disinfection, HVAC systems, water systems, operator training, environmental controls, and others which together contribute to the aseptic process. An essential element is the process simulation (media fill tests) which is a required tool to demonstrate the effectiveness of contamination control. While manufacturers of aseptically processed materials can label their product to be sterile, the very nature of aseptic processing is not a guarantee of sterility, only achievement of meeting validated criteria of the aseptic process. Knowing this, terminal sterilization can be attributed to a sterility assurance level, while aseptic processing incorporates further controls to reduce risk to the end user.
Missouri Valley Chapter Explores Process Validation Topic
The Spring Meeting of PDA’s Missouri Valley Chapter was held April 15 in Overland Park, Kan. Close to 70 attendees gathered to hear presentations from U.S. FDA and industry representatives associated with the implementation of the FDA’s process validation guidance.
The Spring Meeting of PDA’s Missouri Valley Chapter was held April 15 in Overland Park, Kan. Close to 70 attendees gathered to hear presentations from U.S. FDA and industry representatives associated with the implementation of the FDA’s process validation guidance.
Read the full June Issue (Member's Only)
In this month’s issue of the PDA Letter, Hank Rahe looks at EMA’s proposed guidelines on cytotoxic limits. Mark Sebree discusses BD’s plans to manufacture a new line of prefilled sterile injectables. Plus, this month’s infographic showcases key events in the history of sterile manufacturing.
In this month’s issue of the PDA Letter, Hank Rahe looks at EMA’s proposed guidelines on cytotoxic limits. Mark Sebree discusses BD’s plans to manufacture a new line of prefilled sterile injectables. Plus, this month’s infographic showcases key events in the history of sterile manufacturing.