Certification-Quality Documents and SOPs

 

IPEA Quality Documents
Document Number Revision Number Title Effective Date
QM 4 Quality Manual 7/26/2012
1 0 Application for Certification 6/19/2009
2 2 Evaluation and Certification Procedures 3/11/2011
3 0 Requirements for Certification 6/19/2009
4 0 Rights and Duties 6/19/2009
5 1 Certification Pre-audit questionnaire 6/19/2009
6 0 Audit Observations 3/13/2009
7 0 IPEA Certification Agreement 10/2/2009
IPEA Standard Operating Procedures
Document Number Revision Number Title Effective Date
0 4.1 Document Management System 4/3/2012
1 2 Audit Process Overview 5/27/2011
2 2 Auditor Qualification 7/8/2011
7 2 IPEA Certification Board 9/15/2011
8 2.1 IPEA Certification Criteria 2/17/2011
9 4 Certificate of Excipient GMP Conformance 3/3/2012
11 2 Conflict of Interest 1/26/2012
14 1.2 Application for Certification 3/11/2011
16 2 Appeals, Complaints, and Disputes 10/19/2009
17 2 Post Certification Review 7/24/2012
19 1 Quality System Change Notification 11/27/2009
20 2 Conducting the Certification Audit 8/18/2011
22 1 Confidentiality 3/25/2011
24 1.1 Documenting the Certification Audit 2/17/2011
25 1 Authorized Use of the Certificate and Mark 5/24/2011
28 0 Certification Agreement 7/7/2011
29 1 Audit Report Sale 3/11/2011
31 0.1 Certification Lead Auditor Qualification 4/6/2010
32 0 The Surveillance Certification Audit 10/12/2011