Enter the first customer review for this item
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 perfekt working tool: compact and practice-oriented!
2 PDF- and 1 Word file, 99 pages
4th edition 2016
Delivery immediately after receipt of payment
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
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.
Reading Sample "Questionnaire for preparing GMP-inspections"
Please enter these characters in the following text field.
This file is in PDF and Microsoft Word „.docx" format!
Filesize: 2,54 MB
To view PDF files, we recommend using the Adobe Reader.
The download is password protected to prevent copying and modification of content.
Please note the following procedure guidelines:
For payment by invoice:
When paying by credit card:
for the Transport and Storage of Medicinal Products for Human Use, Active Substances and...
Ask your supplier the right questions - this questionnaire will help you!Standard draft to...
SOP "GMP-Questionnaire: Contract Manufacturing / Contract Analysis"Standard draft to adapt...
With this GMP newsletter you will be regularly informed on the latest developments in GMP.
Please select your currency
This includes cookies which are necessary for the operation of the website
and to manage our corporate commercial objectives, as well as other cookies
which are used solely for anonymous statistical purposes, for more comfortable website settings,
or for the display of personalised content. You are free to decide which categories you would like to permit.
Please note that depending on the settings you choose, the full functionality of the website may no longer be available.
These cookies are necessary to run the core functionalities of this website, e.g. security related functions.
With these cookies we can also detect if you want to stay logged into your profile to provide you with fast access
to our services after revisiting our website.
In order to continuously improve our website, we anonymously track data for statistical and analytical purposes.
With these cookies we can, for example, track the number of visits or the impact of specific pages of our web presence and therefore optimize our content.