Questionnaire for preparing GMP-inspections

Beschreibung

This convenient document contains in-depth background information about planning and carrying out audits. The questionnaire with more than 650 questions typically asked during audits or inspections, is arranged by subject-matter. Both parts of the book prepare you in an excellent way for audits (internally and externally) and inspections. The section of the corresponding GMP guidelines is quoted next to each question. This way the background of the question and possible answers can be easily researched in the original guidelines and laws. The questionnaire is a catalogue of typical general questions, which may be asked during an inspection. The questions are referenced to the corresponding GMP regulations. In cases of doubt, the relevant original text can be quickly found. These are the main topics of the questionnaire: I General questions for manufacturers of medicinal products and active pharmaceutical ingredients (API) II Manufacturing and testing of sterile products III Trade of active pharmaceutical ingredients (API) and excipients The GMP Audit Questionnaire works great for both sides - the auditor and the inspected company. It facilitates an efficient preparation for - an audit or an inspection to come - self-inspections - your own GMP audit of suppliers and subcontractors.

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