Questionnaire for preparing GMP-inspections
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For auditors and manufacturers of drugs and APIs.
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.
Your perfect working tool: compact and practice-oriented!
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2 PDF- and 1 Word file, 99 Seiten
ISBN: 978-3-95807-052-3
4th edition 2016
Excerpt from the GMP Compliance Adviser
This convenient document contains in-depth background information about planning for and carrying out audits. With more than 650 questions typically asked during audits or inspections, the questionnaire 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.
Now modifiable: Print your checklist out, delete redundant sites or add new sites – use the document in your own convenient way.
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 in 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.
The book contains the following chapter from the GMP Compliance Adviser:
A perfect workingtool in a compact format with a plenty space to write down your notes.
Weitere Informationen
Reading Sample "Questionnaire for preparing GMP-inspections"
- auditors
- pharmaceutical manufacturers
- suppliers
Technical Requirements
This file is in PDF and Microsoft Word „.docx" format!
Filesize: 2,54 MB
To view PDF files, we recommend using the Adobe Reader.
https://get.adobe.com/de/reader/
The download is password protected to prevent copying and modification of content.
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