GxP Pharmaceutical: GMP, GCP and GLP for the Pharmaceutical Industry
GxP compliance for pharmaceutical laboratories, CMOs and CROs. IgeraIndustria answers on process validation, equipment qualification, Batch Records and Annex 11 with exact regulatory requirement citations.
EU GMP
European Good Manufacturing Practices: 3 parts + 20 technical annexes. Annex 11 governs computerised systems.
IQ/OQ/PQ
Three mandatory qualification phases for equipment and systems affecting medicinal product quality per EU GMP Annex 15.
100%
Of medicinal product batches must have a complete, reviewed Batch Record before being released to market.
Frequently asked questions — GxP Pharmaceutical
What does GxP mean and what good practices does it include?
GxP is the collective acronym for all regulated "Good Practices" in the pharmaceutical industry and health sciences. The main ones are: GMP (Good Manufacturing Practices) for medicinal product manufacturing; GCP (Good Clinical Practices) for clinical trials; GLP (Good Laboratory Practices) for non-clinical studies; GDP (Good Distribution Practices) for the distribution chain; and GPvP (Good Pharmacovigilance Practices) for post-marketing surveillance. Non-compliance with GxP can result in withdrawal of marketing authorisation, regulatory fines or criminal liability.
What is process validation and when is it mandatory?
Process validation is the documented evidence that a manufacturing process consistently produces a product meeting its specifications and quality attributes. GMPs (EU GMP Annex 15, FDA Process Validation Guidance) require validation of all manufacturing processes affecting final product quality. The modern lifecycle approach distinguishes three stages: Stage 1 (process design, Design of Experiments), Stage 2 (process qualification, PQ) and Stage 3 (continued process verification). Validation must be performed before product commercialisation and upon significant process or equipment changes.
What is the difference between IQ, OQ and PQ in equipment qualification?
IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) are the three phases of equipment and system qualification per GMP. IQ verifies that the equipment is correctly installed per manufacturer design and specifications. OQ verifies that the equipment operates within specified limits under test conditions (without product). PQ verifies that the equipment consistently produces product of acceptable quality under real process conditions. All three phases are an explicit requirement of EU GMP Annex 15 and FDA equivalents for any equipment affecting medicinal product quality.
What is a Batch Record and what must it mandatorily contain?
The Batch Record (or Master Batch Record) is the document recording all manufacturing information for a specific product batch. Per EU GMP Part II and FDA 21 CFR Part 211, it must contain: unique batch identification, master batch formula, detailed description of each process step, material weighing records, process conditions (temperature, pressure, time), in-process control results (IPC), operator and reviewer signatures for each critical operation, and final batch review result (Batch Release). The Batch Record is the primary evidence inspected by the FDA or EMA during a GMP inspection.