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Guide to Good Validation Practice, 3rd Edition
Drug and Market Development Publishing, Aug 2007, Pages: 213
The Guide to Good Validation Practice, 3rd Edition is devoted to considering in greater detail the ways of complying with validation requirements at all stages of drug research, development and manufacture. The particular problems associated with the newer biopharmaceutical products are given special consideration. To complete this comprehensive guide to validation and its problems, full texts are provided of the major guidelines issued by National and International regulatory authorities, along with the relevant abstracts from the GLP, GMP, and GCP regulations. Other references include web sites for the retrieval of the text of regulations and guidelines, a list of useful publications, and of some well-known firms specializing in validation consulting.
Validation is now considered not to be a one-time event in the development and finalization of a particular process or analytical method. A proper program for validation, especially of processes, must include a 'life cycle' approach. The ongoing monitoring of manufacturing processes is a key element in this process. Priorities in validation must be based upon an accepted risk evaluation process, with those processes posing the greatest potential for risk to the integrity of the product being given the highest priority. This will involve the application of the concept of Quality by Design, emphasized in new guidance on Quality Management Systems and Process Analytical Technology.
For these reasons, the Guide to Good Validation Practice, 3rd Edition is devoted to considering in greater detail the ways of complying with validation requirements at all stages of drug research, development and manufacture. The particular problems associated with the newer biopharmaceutical products are given special consideration.
To complete this comprehensive guide to validation and its problems, full texts are provided of the major guidelines issued by National and International regulatory authorities, along with the relevant abstracts from the GLP, GMP, and GCP regulations. Other references include web sites for the retrieval of the text of regulations and guidelines, a list of useful publications, and of some well-known firms specializing in validation consulting.
Questions Answered
-What should be validated in manufacturing processes and analytical test methods?
-When should validation be applied?
-Who should be responsible for validation?
-What happens if you don't validate?
Target Audience
This Guide will prove beneficial to the following professionals involved in Pharmaceutical, Biopharmaceutical, Biotechnological, and Biological development and manufacturing specifically working within Quality Assurance, Engineering, Process Validation, Product Development, Quality Control and Analytical Test Validation
About the Author
Dr. Alex Kanarek has operated his own consultancy (originally Bio- Development Consulting Services, now AK Consulting) for the past 14 years. Based upon more than 30 years' experience in the biopharmaceutical industry, his consultancy has specialized in technology transfer, biopharmaceutical development and regulatory compliance in development and manufacturing laboratories. Dr. Kanarek is now on the Editorial Advisory Board of the BioProcess International journal
Product samples
Good Validation Practice - Sample
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