Annex 1 Pre Audit Questionnaire
Annex 1 Pre Audit Questionnaire
Annex 1 Pre Audit Questionnaire
Annex 1–
Pre-Audit Questionnaire
_________________________________________________________________________
This template has been developed by APIC/CEFIC. You may use the templates for your internal auditing purpose but for the
purpose of a Third Party Audit, please note that only APIC Certified Auditors are authorised to perform an official APIC Audit
that is coordinated by the API Compliance Institute. While efforts have been made to assure the accuracy APIC/CEFIC cannot
be held liable for any errors or omissions. You are not allowed to delete this disclaimer when using this template.
ACI : Auditing Guide – Annex 1 Page 2/9
When used as part of the APIC Audit Programme, the following section applies:-
Anne Günster
E-mail: guenster@api-compliance.org
Tel: +49 6221 8444 50
Fax: +49 6221 8444 34
The questionnaire together with the accompanying information should be sent back to the API
Compliance Institute (addressee above) after completion.
________________________________________________________________
Name, Function
________________________________________________________________
Date, Location, Signature
ACI : Auditing Guide – Annex 1 Page 3/9
Preamble
It is the purpose of this questionnaire to facilitate the preparation of the auditors for the audit at your
company and to make it as efficient as possible. It is neither intended for self-assessment nor for vendor
rating or qualification.
All information provided in this questionnaire will be treated strictly confidential. Nevertheless it is
acceptable if your company chooses not to answer some of the questions listed below.
In case your company agrees to submit some/all of the requested documents these will be returned to
your company after the Audit Report is signed and issued.
1. Company name
2. Address of Company
Name of production plant to be
3. audited and address if different
from no. 2
Telephone (Switchboard)
4. and Fax number
where the audit takes place
Name of the “audit
5. representative” of the company
for the audit (contact person)
E-mail address and telephone
6.
number of the contact person
Name of product(s) subject to
7.
the audit
8. Approximate size of the plant
Approximate number of
9.
employees
Is this a pure production site or
are there other Headquarters
10.
functions (e.g. Research)
located at the site?
Are there other companies
11. located on the same area as the
company to be audited?
If so, which companies are
12. these and what types of
products are produced?
ACI : Auditing Guide – Annex 1 Page 4/9
Please provide any additional information your company feels the auditors should be aware of before the
audit:
ACI : Auditing Guide – Annex 1 Page 9/9
F. Requested Documents
To facilitate proper preparation of the auditors we encourage you to provide the following documents in
advance.
Documents are provided on a purely voluntary basis, but we guarantee that the submitted documents will
be treated strictly confidential. All documents will be returned after the audit report is issued. If not
provided please ensure these documents are available at the opening meeting of the audit
2. CEP(s) if applicable
6. Site Master File or at least a site map and drawings of production areas
9. Index of Quality Manual and / or Index of SOP’s covering ICH Q7 Chapters relevant to your operations.