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Excerpts from the GMP Compliance Adviser
More than 650 typical questions related to audits and inspections.Each question with reference to the current EU GMP Guide Part I/II and the 21 CFRs 210/211/11.For auditors and manufacturers of drugs and APIs.NEW: Now modifiable!
for the Storage and Transport of PharmaceuticalsMore than 700 questions with reference to regulations on preparing for and carrying out Good Distribution Practice (GDP) audits
This report is a "must have" guidance for all those who are involved in qualification and validation: It provides information about regulatory requirements, risk management, life cycle concepts and much more. NEW ++ NEW ++ NEW
Excerpt from the GMP Compliance AdviserRequirements for Quality Management Systems - learn more about the principles of data integrity, systems to monitor data integrity and the storage and archiving of records.NEW ++ NEW ++ NEW
Excerpt from the GMP Compliance AdviserA Guide for Drug and Device Manufacturers - learn more about the four phases of qualification.NEW ++ NEW ++ NEW
A comprehensive step-by-step guide, which covers all aspects of selecting and managing contractors.NEW ++ NEW ++ NEW
A Model to Implement and Run a Compliant Freeze Drying ProcessExcerpt from the GMP Compliance Adviser
Guide to prepare a company for compliance with Good Distribution Practice (GDP)
This management report spells out how U.S. and EU manufacturers must handle sterile processing.
This handbook tells you what you need to know about the similarities - and subtle differences - between FDA and EU GMP inspections.
Just when you think you’ve got the FDA’s requirements figured out, the EU issues its own. Do you know how they differ? Here you'll find a step-by-step guide to implementing a computer validation program that will satisfy U.S. and EU regulations.
Strategies for Successful Company-Wide ImplementationEvery page offers practical strategies to implement a company-wide change control program and meet FDA regulatory requirements.
Instructions for preparing a Site Master File according toPIC/S PE 008-4Without an up-to-date Site Master File, you are not authorized to market pharmaceuticals to European customers.