FDA Updates Drug cGMPs Requirements: Revised Standards for Water Quality, Verification, Aseptic Processing
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ALERT: On Dec. 4, 2007 the FDA issued proposed changes to the drug cGMPs (21 CFR 210/211). The revised standards affect three major areas: water quality, verification by a second individual and aseptic processing.
Water quality — The rules remove the defined EPA water standard and replace it with "water fit for human consumption." But the standard of fit for human consumption can vary from one country to another. Do you know what it is for your outsourced suppliers? Could your product be tainted, yet cGMP-compliant?
Verification — The changes state that when operations are performed by automated equipment, only one person is needed to verify that the automated equipment is functioning accurately. But do you really want to have just one person verifying cleanliness of equipment or adding materials to a batch?
Aseptic processing — The new rule makes numerous updates to equipment cleaning and maintenance, testing and approval or rejection of components, drug product containers and closures, sampling and testing of in-process materials, and control of contamination.
How will these new revised standards affect your company and how do they fit within your overall cGMP compliance program? What are the FDA's cGMP priorities and what can you expect should you face an inspection this year?
Compliance expert Barbara Immel delves into these changes and updates you on the current state of cGMP compliance. She'll examine recent FDA inspection trends for drugs, devices and biologics, recent serious compliance cases and current cGMP enforcement. Plus, Barbara will analyze several of the more than 70 cGMP-related warning letters issued during the last 12 months.
Order now for your entire team to listen and discover:
- Point-by-point analysis of the proposed GMP changes and new draft guidance
- Recommendations for how your company can submit comments to affect the Direct Final Rule
- Potential unintended consequences of the proposed Direct Final Rule as written
- Analysis of the more than 70 GMP-related warning letters issued during the last 12 months
- Where FDA investigators are focusing their attention regarding GMPs
- Review of recent serious compliance cases and strategies for not making the same mistakes
- 10 Dos and don'ts for creating and maintaining compliant GMP operations
Order now and you'll have a clear picture of what these proposed new rules will mean to you.