• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Shopping cart
Your shopping cart is empty

Show shopping cart...

Image

Stay informed!

If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices

 

>>> REGISTER for our free GMP Newsletter LOGFILE

GMP Audits and Inspections

GMP Audit Checklist (Download)
Choose product version:
GMP Audit Checklist (Book) GMP Audit Checklist (Download)
€ 199.00
net
€ 236.81
  19% VAT included
US$
299.00
PDF-Download
for Pharmaceutical and API Manufacturers
138 Pages
ISBN: 978-3-943267-38-9
Excerpt from the GMP MANUAL

This convenient document contains in-depth background information about planning and carrying out audits. In addition it contains a checklist with more than 700 questions typically asked during audits or inspections.
It is worth using checklists to deal with the questions that a GMP inspection may typically bring up. These can be considered carefully beforehand, e.g. which internal documents need to be kept at hand for a certain question – this will save some moments of panic during the inspection.

The checklist 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. The information sources include the 21 CFR 210/211/11 as well as the EU-GMP-Guide Parts I and II.

The GMP Audit Checklist 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.

Click & View: GMP Audit Checklist

Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

If you choose payment by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • The invoice will be sent by postal mail as soon as possible.

Technical Requirements

This file is in PDF format! To view these files, you need Adobe Reader installed on your computer. If you don't, you will need to download and install it.

>>> Adobe Reader - free download

- auditors
- pharmaceutical manufacturers
- suppliers
Recommendations
Preparing for the EU GMP Inspection
GMP Supplier Assessment Questionnaire
GDP Audit Checklist (Download)