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Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - Syed Imtiaz Haider, Erfan Syed Asif (CRC, 2012) pdf

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 							ISBN 9781439886922
  
  
  
  To stay in
compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the
regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing
steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-ROM take into
account all major international regulations, such as FDA, EU GMP, cGMP, GLP, PDA technical monographs, PDA technical
reports, PMA concepts, journals of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation
guidelines. No other resource deals exclusively with the key elements of quality control and quality assurance
procedures for pharmaceutical operations and provides hands-on templates to be tailored to achieve global regulatory
compliance.
  
  
  The book provides instant answers about what to include in critical quality assurance
and quality control SOPs and how to enhance productivity. The CD-ROM contains nineteen quality control and thirty-three
quality assurance SOPs designed so that users can input them into their computers and use their Microsoft Word programs
to edit and print these documents. The book ensures minimization of the number of documents, helping to reduce the
nightmare-like aura that surrounds an FDA audit. The SOPs exclusively refer to the documents specially required for
compliance; however, specific formats are not included to ensure that the electronic templates can be easily used by
pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries. 						

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