Référentiel santé et accréditation ANAESIndustrialisation et qualité en production (ERE)

Know the normative requirements in the field of health, especially in pharmaceutical establishments manufacturers

General introduction on quality and quality control • The quality of a drug: legislative and regulatory aspects • The various quality control tools within the pharmaceutical industry: GMP and the "six M" rule, quality control, self-inspection, calibration, qualification

Hygiene and cleanliness • Special and microbial contamination • Control of micro-organisms (cleaning, disinfection and sterilization) • Dressing rules

Premises and equipment • General information on material flow with emphasis on possible cross-contamination • Filtered air, overpressure and ZAC

Staff • The organization chart and the assignment of functions • General information on key positions in the pharmaceutical industry

Documentation • Traceability and responsibility through: o Lot records (manufacture and packaging) o Procedures and records

Table control (Duration 1h)

"Good Manufacturing Practices" version 2015/12 bis