PHARMACEUTICAL QUALITY & CAREERS

Practical pharma quality knowledge for real-world work.

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21 CFR Part 11 in Pharma: Requirements, Audit Trails & Electronic Signatures

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  Published by: Pharma Quality System Editorial Team • Editorial basis: 21 CFR Part 11, FDA Part 11 Scope and Application guidance, and FDA CGMP records guidance ELECTRONIC RECORDS • ELECTRONIC SIGNATURES • DATA INTEGRITY 21 CFR Part 11 is one of the most important FDA regulations for electronic records and electronic signatures. In pharmaceutical environments, it matters when regulated records are maintained electronically and fall within Part 11's scope. Quick answer 21 CFR Part 11 is the FDA regulation that establishes criteria for certain electronic records and electronic signatures so they can be considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. It works together with the underlying FDA recordkeeping requirements, often called predicate rules . Important scope note: Not every electronic file in a pharmaceutical company is automatically a Part 11 record. FDA's current guidance interprets Part 11 sc...
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Good Documentation Practices (GDocP) in Pharma: Rules, ALCOA+ & Examples

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  Published by: Pharma Quality System Editorial Team • Editorial basis: WHO GMP, FDA CGMP/data-integrity guidance, and ICH Q7 documentation principles GMP • DOCUMENTATION • DATA INTEGRITY Good Documentation Practices are the everyday rules that make pharmaceutical records reliable, traceable, reviewable, and inspection-ready. A strong documentation system shows what was done, who did it, when it was done, and whether the activity followed approved procedures. Quick answer Good Documentation Practices (GDocP) are the controls used to create, review, correct, approve, issue, retain, and retrieve pharmaceutical records so that activities are documented accurately and can be reconstructed. GDocP supports GMP and data integrity and should be applied to both paper and electronic records. Terminology note: In this article, GDocP means Good Documentation Practices. We avoid using on...
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Data Integrity in Pharmaceutical Industry: ALCOA+ Principles, FDA Guidance & Examples

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  Published by: Pharma Quality & Careers Editorial Team • Editorial basis: FDA data-integrity guidance and WHO pharmaceutical data-integrity principles GMP • QUALITY SYSTEMS • LABORATORY & MANUFACTURING DATA Pharmaceutical decisions are only as reliable as the data behind them. Data integrity means that records remain complete, consistent, accurate, attributable, and trustworthy throughout their lifecycle—from the moment data are generated until they are reviewed, reported, retained, and retrieved. Quick answer In the pharmaceutical industry, data integrity is the assurance that data are reliable and remain trustworthy throughout their lifecycle. WHO describes the expected characteristics using ALCOA+ : Attributable, Legible, Contemporaneous, Original or a true copy, Accurate, Complete, Consistent, Enduring, and Available. FDA expects firms to use meaningful, risk-based controls to prevent and detect data-integrity problems under CGMP. Table of Content...
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OOS in Pharmaceutical Industry: Investigation, Phase I & II, Examples

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Published by: Pharma Quality & Careers Editorial Team • Editorial basis: FDA OOS guidance and current GMP quality-system principles Pharmaceutical Quality Control & Laboratory Investigations An Out-of-Specification (OOS) result is not simply a failed number to retest until it passes. It is a quality signal that requires a scientifically sound, documented investigation to determine whether the result reflects laboratory error, manufacturing variability, material failure, or another assignable cause. Quick answer In pharmaceutical testing, OOS means a test result falls outside an established specification or acceptance criterion. FDA expects the result to be investigated rather than ignored or averaged away. The investigation generally begins with a focused laboratory assessment and expands to a full-scale investigation when a conclusive laboratory cause is not established. Table...
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