Pharmaceutical Process Validation, Second EditionIra R. Berry, Robert A. Nash The second edition of this text has been updated and enlarged to reflect current good manufacturing practice (CGMP) regulations and the increased interest in, and applicability of, process validation. "Pharmaceutical Process Validation" offers up-to-the-minute coverage of: regulations and validation; sterile process validation; organization in validation processes; solid dosage forms validation; raw material validation; analytical methods validation; and prospective and retrospective validation. Providing the contributions of leading experts in the field, the text also supplies examinations of current concepts in validation and new topics, such as: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation. |
Contents
Preface | ix |
The Regulatory Basis for Process Validation | 1 |
Organizing for Validation | 9 |
Copyright | |
18 other sections not shown
Common terms and phrases
acceptable achieve active addition analysis application approach appropriate approved assay batch blend calibration challenge chamber characteristics chart cleaning complete components concentration considered container critical cycle demonstrate described determine distribution documentation dosage form drug drying effect ensure equipment established evaluation example facility Figure filter final flow formulation function granulation heat important indicator individual ingredient installation laboratory limits liquid listed load manufacturing means measured medium method microbial monitoring necessary operation organization parameters particle performed personnel pharmaceutical phase possible prepared presented pressure problems procedures process validation protocol qualification range raw material records reference removed responsible sampling selected solution specifications standard statistical steps sterilization studies surface Table tablet temperature tion treatment uniformity unit usually valve variables