GXP ACADEMY · GXP INSIGHTS
Practical analysis of GMP, Pharmaceutical Quality Systems, deviations, CAPA, change control, audits and risk management. Built to support sound interpretation, defensible decisions and stronger evidence.
ANALYSIS & PRACTICAL GUIDES
Quality systems, audit readiness and GMP processes explained through concrete criteria, examples and practical points of attention.
A GDP audit checklist for the storage and transport of pharmaceuticals, based on the EU Guidelines 2013/C 343/01: temperature mapping, temperature monitoring, carrier qualification and returns management.
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EU GMP Chapter 4 defines how GMP documentation is created, controlled and retained. This guide covers the required document types, good documentation practices for entries and corrections, minimum...
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How to build a compliant IQ OQ PQ template: the structure of the qualification protocol per EU GMP Annex 15 and PIC/S PI 006-4, minimum contents of Installation,...
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A GMP audit checklist turns self-inspection into a defensible process: areas to cover per EudraLex Chapter 9, evidence to collect and PIC/S-style finding classification. A complete template with...
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How cleaning validation acceptance criteria calculation works in practice: from HBEL and PDE to MACO, down to the swab limit corrected for recovery. Formulas, a worked example and...
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How to write a GMP quality manual that truly describes your pharmaceutical quality system: contents required by ICH Q10, a proven structure, differences from the Site Master File,...
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How to write a GMP deviation report that stands up in audit: a template with the 10 key sections, a worked example and the mistakes inspectors cite most...
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What is the difference between GMP and GLP? GMP governs the manufacturing and quality control of medicinal products, while GLP governs nonclinical safety studies. A practical guide with...
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Updated and expanded version of the batch record article: structure under EU GMP Chapter 4 and 21 CFR 211.188, a complete four-step batch record review checklist, review by exception in...
Updated and expanded version of the batch record article: structure under EU GMP Chapter 4 and 21 CFR 211.188, a complete four-step batch record review checklist, review by exception in...
How to set up a defensible GMP deviation classification: risk-based criteria to distinguish critical, major and minor deviations, practical examples and escalation rules. With references to EudraLex Chapter 1, ICH...
How to set up a defensible GMP deviation classification: risk-based criteria to distinguish critical, major and minor deviations, practical examples and escalation rules. With references to EudraLex Chapter 1, ICH...
A GDP audit checklist for the storage and transport of pharmaceuticals, based on the EU Guidelines 2013/C 343/01: temperature mapping, temperature monitoring, carrier qualification and returns management.
A GDP audit checklist for the storage and transport of pharmaceuticals, based on the EU Guidelines 2013/C 343/01: temperature mapping, temperature monitoring, carrier qualification and returns management.
EU GMP Chapter 4 defines how GMP documentation is created, controlled and retained. This guide covers the required document types, good documentation practices for entries and corrections, minimum retention periods...
EU GMP Chapter 4 defines how GMP documentation is created, controlled and retained. This guide covers the required document types, good documentation practices for entries and corrections, minimum retention periods...
How to build a compliant IQ OQ PQ template: the structure of the qualification protocol per EU GMP Annex 15 and PIC/S PI 006-4, minimum contents of Installation, Operational and...
How to build a compliant IQ OQ PQ template: the structure of the qualification protocol per EU GMP Annex 15 and PIC/S PI 006-4, minimum contents of Installation, Operational and...
A GMP audit checklist turns self-inspection into a defensible process: areas to cover per EudraLex Chapter 9, evidence to collect and PIC/S-style finding classification. A complete template with the mistakes...
A GMP audit checklist turns self-inspection into a defensible process: areas to cover per EudraLex Chapter 9, evidence to collect and PIC/S-style finding classification. A complete template with the mistakes...
PRACTICAL GMP TOOLS FOR PHARMA
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