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Excerpts from the GMP Compliance Adviser
How to Meet the GMP Requirements of Annex 16 EU GMP Guide Batch release is complex and challeging due to requirements, responsibilities and the global product flow. Make sure to safely circumvent the multiple pitfalls that lie in wait – Order now!NEW ++ NEW ++ NEW
How can occured failures be avoided in the future? Start to treat the root cause, not the symptoms! Learn how to set up a failure management system and how to use root cause analysis methods and tools correctly! NEW ++ NEW ++ NEW
A number of different approaches can be taken when it comes to the qualification of analytical instruments. But which one should you take?This pdf download will help you mastering all phases of qualification and calibration! incl. form for a requalification report, samples of a qualification plan and report, sample calibration SOP NEW ++ NEW ++ NEW
Step-by-step through the whole qualification process of water treatment systems including sample documents for all stages! The qualification of pharma water systems has never been so easy!NEW ++ NEW ++ NEW
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.Your perfekt working tool: compact and practice-oriented!NEW: Now modifiable!
for the Transport and Storage of Medicinal Products for Human Use, Active Substances and Medical DevicesNEW: now also for active substances and modifiable!More than 700 questions with references to GMP/GDP regulations and EN ISO 13485 on the preparation and implementation of Good Distribution Practice (GDP) auditsYour perfect working tool: compact and practice-oriented!
Does your cleaning validation meet the current requirements of Annex 15 to the EU GMP Guidelines?This report offers you practical strategies to implement an up-to-date cleaning validation and meet regulatory requirements.
A qualification serves to prove that equipment is fit for its given purpose. So far, so good. But what are the actual fundamental requirements for a successful equipment qualification and what are the core elements of qualification work?
Nowadays all regulatory authorities focus on data integrity and have their own data integrity guidelines - however, their regulations don’t always agree. With this pdf download you will understand all the requirements! This report details the ins and outs of all three documents of EMA, MHRA and WHO and explains how the FDA regulations fit in.
This pdf download lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ and PQ - that satisfies US and EU requirements.incl. checklists for carrying out a qualification plan and instructive diagrams
A comprehensive step-by-step guide, which covers all aspects of selecting and managing contractors.
This pdf download is the ultimate guide to preparing your company for compliance with GDP. Step by step, it walks you through the planning and implementation process, including the six key requirements included in the EU GDP Guidelines!
Discover the tools you need to develop your trans-national validation program.Use this step-by-step guide to implement a computer validation program that will satisfy U.S. and EU regulations!