It gives practical advice on a subject that is being actively discussed throughout the industry. This monograph is intended for all those involved in validating the cleaning of pharmaceutical equipment, whether they are employed in development, production or packaging. This has been developed from a distillation of the approaches to packaging equipment validation from a number of UK based pharmaceutical companies and offers a practical approach to this complex subject. Pharmaceutical Premises and Environment - New Revised Edition, May 1998 Location, construction and environmental requirements of pharmaceutical factories. Provides practical advice on design and maintenance of premises.
Additional guidance is given including cross contamination, process validation and change control.
Elements and Philosophy of Pharmaceutical Quality Assurance Deals with the concept, current practice and future development of Quality Assurance in pharmaceutical manufacture. This mongraph is applicable to all sectors of the distribution network worldwide. The scope is deliberately limited to finished medicinal products for human use, but similar principles will apply to medicinal products for veterinary use. Bulk Pharmaceutical Chemicals Details practical GMP guidelines for Bulk Pharmaceutical Chemicals. Pharmaceutical Documentation Provides guidance on the documentation requirements for the successful manufacture and control of medicinal products.