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…
Tag Archive for pharmaceutical
GAMP5 Definitions: Assigning Categories for Software Validation and Documentation
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Q: Under GAMP5 definitions, I’ve found that assigning a category to a software product is a bit confusing — particularly distinguishing between Category 3 and 4. My understanding is that Category 3 software allows the user to make selections (configure) the…
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,…
Internal Audit Reports: Best Practices for Shielding Findings from FDA Eyes
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Q: My company has an SOP that defines which documents are considered Non-Disclosure Information. The SOP includes findings in our internal audit reports. Does FDA have the right to see these confidential documents anyway? A: We get this question frequently, and the…
Annex 11: Does It Apply to Medical Device Companies?
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Q: In a previous EduQuest-ions & Answers post, you discussed how the European Union’s Annex 11 compares with FDA’s Part 11. It’s my understanding that the EU rule applies only to pharmaceutical companies. Is that correct, and, if so, are there any…
Validating Purity: Problems in Meeting the EMA Reference Standard
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Q: I’ve got a question about validating purity according to Section 7 of the EMA Guidelines for Method Validation (effective February 2012). In the Reference Standards section for Ligand Binding Assays (7.1.1.1.), the guideline says, “Macromolecules are heterogeneous and their…
CAPAs from Internal Audits: 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 CAPAs from internal audits — but if you’re a medical device company, it can’t. Is that correct? Also, can the FDA request to see the…
Role of the Responsible Person Under EU’s New Good Distribution (GDP) Practices Guidelines
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Q: I understand the EU’s new Good Distribution Practices (GDP) for medicinal products require that an individual must be named as the primary responsible person for GDP compliance. Could you elaborate on this requirement? A: The new EU GDP Guidelines — which went…
Internal Audit Report: Can FDA Request Yours?
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Q: Does FDA have the legal right to request an internal audit report or an annual product review report? I’ve heard that in most cases FDA won’t request those kind of reports, but instead may ask to review our Standard Operating…