WHO GMP matters far beyond any one country. It is the standard used in WHO prequalification inspections of medicines supplied through international procurement, and many national medicines regulators — across Africa, Asia and other emerging markets — adopt WHO GMP or base their national GMP on it. India’s Revised Schedule M was itself aligned with WHO GMP. For a manufacturer exporting to these markets, WHO GMP is often the common language of every inspection.
The main principles cover
- Pharmaceutical quality system, with management responsibility, quality risk management and product quality review.
- Sanitation and hygiene, qualification and validation, and complaints and product recalls.
- Contract production and analysis, and self-inspection, quality audits and supplier audits and approval.
- Personnel and training, premises, equipment and materials — including quarantine, sampling, testing and release of starting materials.
- Documentation — specifications, master formulae, batch processing and packaging records, SOPs and records — kept accurate and controlled.
- Good practices in production and in quality control — process controls, deviations, yields, in-process testing, release, stability and laboratory records.
WHO data integrity guidance
WHO’s data integrity guideline expects the same ALCOA+ attributes that FDA, MHRA and PIC/S describe: data that are attributable, legible, contemporaneous, original and accurate, and also complete, consistent, enduring and available. It asks for risk-based controls across the data lifecycle, audit trails and their review, controlled access, and a quality culture where data integrity problems are reported and addressed.
