GXP ACADEMY · PHARMACEUTICAL SOPS
Practical insights for designing, writing, implementing and maintaining procedures that turn GMP requirements into responsibilities, controls, instructions and verifiable records. Built to reduce ambiguity, deviations and the gap between documents and real work.
SOPS & OPERATING METHODS
SOP writing, analytical method validation, self-inspections, specifications and document processes explained through practical examples and criteria.
The reference SOP format for the pharmaceutical industry: the sections of the template, the requirements of EudraLex Chapter 4 and 21 CFR 211.100, and the most common mistakes...
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A solid SOP numbering system is the first requirement of a GMP documentation system: every procedure must be uniquely identifiable. This guide covers the recommended code structure, SOP...
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How to manage out-of-specification (OOS) results in the QC lab: Phase I and Phase II investigations per FDA and EU GMP, rules on retesting, resampling and averaging, plus...
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How to write a GMP-compliant standard operating procedure (SOP): document structure, EudraLex Chapter 4 requirements, operational steps from draft to approval, the most common mistakes to avoid and...
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Practical Method for Defining and Justifying Impurity Limits (ICH Q3A/B/C/D, M7, Q6A). Typical errors, templates, and inspection defense.
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Master Analytical Method Validation (AMV) according to ICH Q2(R2) and Annex 15. Avoid common errors and prepare your QC for audits.
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Master GMP self-inspection. From risk-based planning (ICH Q9) to CAPA management. The definitive guide for QA, QP, and production managers.
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The reference SOP format for the pharmaceutical industry: the sections of the template, the requirements of EudraLex Chapter 4 and 21 CFR 211.100, and the most common mistakes inspectors catch....
The reference SOP format for the pharmaceutical industry: the sections of the template, the requirements of EudraLex Chapter 4 and 21 CFR 211.100, and the most common mistakes inspectors catch....
A solid SOP numbering system is the first requirement of a GMP documentation system: every procedure must be uniquely identifiable. This guide covers the recommended code structure, SOP numbering examples...
A solid SOP numbering system is the first requirement of a GMP documentation system: every procedure must be uniquely identifiable. This guide covers the recommended code structure, SOP numbering examples...
How to manage out-of-specification (OOS) results in the QC lab: Phase I and Phase II investigations per FDA and EU GMP, rules on retesting, resampling and averaging, plus the key...
How to manage out-of-specification (OOS) results in the QC lab: Phase I and Phase II investigations per FDA and EU GMP, rules on retesting, resampling and averaging, plus the key...
How to write a GMP-compliant standard operating procedure (SOP): document structure, EudraLex Chapter 4 requirements, operational steps from draft to approval, the most common mistakes to avoid and practical tips...
How to write a GMP-compliant standard operating procedure (SOP): document structure, EudraLex Chapter 4 requirements, operational steps from draft to approval, the most common mistakes to avoid and practical tips...
Practical Method for Defining and Justifying Impurity Limits (ICH Q3A/B/C/D, M7, Q6A). Typical errors, templates, and inspection defense.
Practical Method for Defining and Justifying Impurity Limits (ICH Q3A/B/C/D, M7, Q6A). Typical errors, templates, and inspection defense.
Master Analytical Method Validation (AMV) according to ICH Q2(R2) and Annex 15. Avoid common errors and prepare your QC for audits.
Master Analytical Method Validation (AMV) according to ICH Q2(R2) and Annex 15. Avoid common errors and prepare your QC for audits.
PRACTICAL GMP TOOLS FOR PHARMA
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