QAS-012 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 279

SOP No. Val. 100.10 Effective date: mm/dd/yyyy
Approved by:
8. During the early stage of an audit program, it will seek to define absolute fundamental
problems that affect manufacturing and QC operations. As these are resolved, a more criti-
cal awareness of potential problems will be highlighted.
9. The tentative audit checklist will be circulated before audit. It is certainly capable of fur-
ther development and must not be considered as absolute.
31.5 soP audit
SOP audit should cover all SOPs parameters separately step by step, such as subject, approval,
purpose, scope, procedure, and reason for revision.
System SOPs audit is the responsibility of a senior QA officer or designate for all plants except
QA system SOPs to maintain the independence of the auditor.
Attachment D should be used as a system audit checklist. In case of nonconformaties, corrective
and preventive action report Attachment E will be used. Attachment E will clearly identify the
problem (after checking the compliance) mentioning the root cause along with the solution; the solu-
tion implementation plan should be written after discussion with the QA manager. The auditor will
take signature on Attachment E by the relevant auditee. Follow-up of corrective action implementa-
tion will be performed by the SOP auditor on the follow-up date mutually agreed.
31.6 attachments
Attachment A: Checklist for audit
Attachment B: Internal QA audit form
Attachment C: General GMP inspection record
Attachment D: System SOP audit checklist
Attachment E: SOP audit/corrective and preventive action report
31.7 reason for revision
First time issued for the ABC Pharmaceutical Industries.