Q: What is FDA’s perspective on contracts or quality agreements with sister sites — sites owned or operated by the same parent company — that supply the primary manufacturer with materials or components? When using a sister site as a…
Tag Archive for Audit
FDA Outsourcing Rules: Do They Cover More than Contract Manufacturers?
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Q: Question about FDA outsourcing rules: ISO 13485 requires that when an organization chooses to outsource a process that affects product conformity with requirements, the organization must ensure control over such processes. It also says that control of outsourced processes should…
Latest FDA Enforcement Hot-Spots and Targets: The View from the Trenches
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Q: I’m a Quality Auditor and looking for information on the latest FDA enforcement focus. From your perspective as an ex-FDA investigator who now helps industry avoid trouble, what is FDA enforcement “going after” these days? A: Supplier management — how carefully…
ER Analogy: When to See the CAPA “Specialist”
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Q: My company continues to struggle with deciding when to elevate a complaint to the level of a CAPA. And at times we disagree about how to differentiate complaints, non-conformances, and CAPAs. Can you help us sort it all out? A:…
CAPA Data Sources; What Makes a Compliant CAPA System
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Q: My question is about what makes a compliant CAPA system, including appropriate CAPA data sources. We recently received a 483 notice citing inadequacies in our CAPA system. Could you review for me FDA’s basic requirements for CAPA? Moreover, what are…
Internal Audits: Are They Really Necessary?
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Q: Question regarding internal audits: is it acceptable for a manufacturing site to NOT have an established internal audit program? In place of internal audits, the manufacturing site uses the results of external audits conducted by regulatory authorities, standards assessment organizations,…
Re-Audits: When and Why Should You Conduct Them?
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Q: What is industry practice — or more importantly, FDA’s viewpoint — regarding re-audits? Do we need defined and documented criteria for when to conduct re-audits? If so, what would such criteria include? A: My experience is that industry rarely does what is…
CAPA Data: What Can FDA Request to See?
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Q: It’s my understanding that during an FDA audit of a pharmaceutical company, the Agency can request to see CAPA data from internal audits — but if you’re a medical device company, it can’t. Is that correct? Also, can the FDA request to see…
FDA Inspection: What’s Available from FDA to Help You Prepare?
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Q: I’m preparing a plan for what to do when an inspector shows up at our site for our next FDA inspection, including who will be the contact person, what information to give the inspector at the start of the inspection,…
Quality System Records: What Evidence Do FDA Inspectors Expect to See in Them?
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Q: Within our company and others, there are varied interpretations of FDA’s expectations of 21 CFR 820.186 — Quality System Records. Can you provide me with guidance on what’s expected to meet this requirement? Also, during an FDA inspection, what are…