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.
ICH Q2(R2) replaced Q2(R1) as the reference for analytical method validation: scope extended to multivariate methods and bioassays, robustness moved into development and a direct link with ICH...
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The cleanroom gowning procedure under EU GMP Annex 1 (2022 revision): garment requirements for Grades A/B, C and D, the Grade B gowning sequence, and personnel qualification and...
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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...
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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 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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What is the difference between GMP and SOP? GMP are the manufacturing standards issued by regulators; SOPs are the standard operating procedures a company writes to implement them. Practical guide...
What is the difference between GMP and SOP? GMP are the manufacturing standards issued by regulators; SOPs are the standard operating procedures a company writes to implement them. Practical guide...
ICH Q2(R2) replaced Q2(R1) as the reference for analytical method validation: scope extended to multivariate methods and bioassays, robustness moved into development and a direct link with ICH Q14. Practical...
ICH Q2(R2) replaced Q2(R1) as the reference for analytical method validation: scope extended to multivariate methods and bioassays, robustness moved into development and a direct link with ICH Q14. Practical...
The cleanroom gowning procedure under EU GMP Annex 1 (2022 revision): garment requirements for Grades A/B, C and D, the Grade B gowning sequence, and personnel qualification and requalification. With...
The cleanroom gowning procedure under EU GMP Annex 1 (2022 revision): garment requirements for Grades A/B, C and D, the Grade B gowning sequence, and personnel qualification and requalification. With...
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 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...
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