Quality Assurance Compliance: Procedures for Pharmaceutical and Biotechnology Manufacturers

Covering key areas of GMP compliance and QA, this text provides sample documentation and systems in use in pharmaceutical, biotechnology, and active pharmaceutical ingredient companies worldwide. Sixty-eight procedures with forms are grouped into eight critical areas: documentation, raw material control, in-process material control, corrective action, deviations and complaints, production cleaning, processing and documentation, QC lab documentation, product quality, and training and health. Fifty-eight forms, reports, and label formats enhance the practicality of the text. Most of the forms presented in the book are included on a diskette in ASCII format.