The importance of quality assurance in the production, storage and use of manufactured preparations is widely recognized. This book encapsulates the issues involved in the manufacture of non-steriles, such as creams, ointments, herbal remedies, shampoos, soaps and toiletry products (as opposed to sterile drugs and injectible products). Knowledge of the microbial limits is expanded, new standards are included, and coverage of the preservation issues of dosage forms is widened to include semi-solids and liquid preparations. This edition also contains new regulations regarding preservative efficacy testing and covers pharmacopoeial and industry regulations and guidelines. Rapid methods are also discussed, now more common in cosmetic and toiletry practice, in their pharmaceutical capacity.The pharmaceutical industry led the way in the change from the QC to the quality assurance (QA) approach. ... The principles and guidelines of GMP are stated in the two almost identical EC Directives, 91/356/EEC (Anon. 1991a) for medicinalanbsp;...
|Title||:||Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries|
|Author||:||R. Baird, Sally F. Bloomfield|
|Publisher||:||CRC Press - 1996-05-01|