IPEA Pre-audit Questionnaire

Submitted by teddy on Fri, 07/08/2011 - 16:21

1. Name: *

Street Address:

City:

State:

Zip Code:

Country:

2. Site Contact Name:

Phone Number:

3. Email Address: *

4. What is the number of employees in the company:

5. What is the number of employees at this site:

6. What is the principle language spoken by plant personnel:

7. What is the language in which procedures are written:

8. What are the types of products or product lines made at the site:

9. Please provide the excipient's compendia, chemical and trade name (if applicable):

10. Is the excipient manufactured under IPEC-PQG Excipient GMPs?:

Yes

If no, what quality system is used (e.g. ISO 9001, or Q7):

11. Please provide an index of the SOPs pertaining to the excipient to be audited.

12. Please list the date of the last excipient regulatory inspection and the name of the agency:

Date of last inspection:

Name of Agency:

13. Are there any subcontractors or other locations used in the manufacture of the excipient such as for production, Quality Control testing, packaging, or warehousing? :

Yes

Please list the type of operation, subcontractor name, and their location:

14. Is there a US Drug Master File for the excipient? (if yes, please list the number):

15. A process flow diagram would facilitate planning for the audit. This diagram should clearly indicate the point at which full GMPs are applied. If one is available, please mail or fax a copy to our office.

16. Is the excipient manufactured in a batch or continuous process?

How is an excipient lot or batch defined?

17. Please provide a description of the lot numbering system with explanation of the coding:

18. Is the equipment dedicated to the manufacture of the excipient and its related non-pharmaceutical grades?:

Yes

If not, what other types of materials are manufactured using this equipment?:

19. Please provide a copy of the organization chart showing the reporting relationship of the Quality Unit. (Please email document separately to info@ipeainc.com)

20. When was the excipient facility commissioned?:

21. Does this facility produce any types of the following bulk materials? (check those applicable):

Penicillin

Steroids

Cephalosporine

Hormones

Cytotoxics

Pesticides

22. Please describe any special safety or dress requirements or other restrictions that may affect the ability to audit the excipient facility (i.e. facial hair, clothing, shoes):

23. Please briefly describe the pest control program (outside contractor, frequency of visits etc).:

24. Are either re-evaluation or shelf life dates assigned to the excipient? If so, what is the duration?:

25. Are excipient retain samples kept?:

Yes

How long are they kept?:

What are the storage conditions?:

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IPEA Inc. is a wholly owned subsidiary of the

International Pharmaceutical Excipients Council of the Americas.

IPEA's Excipient GMP Certification Program is accredited by the

American National Standards Institute.

IPEA offers:

Excipient GMP Conformance Certification
Excipient GMP Audit Program
Excipient GMP Conformance Gap Assessments
Qualification of Excipient Auditors
Auditing Workshops
On Site cGMP Training