Documentation for Audit in Pharma

-For audit successful audit proper documentation play an important role.
-Before, during and after an audit different types of documents are utilised.
-The list given below may not be all-inclusive but consists at least of the major documents:
      -Documentation before audit (Pre-audit documents)
      -During the Audit
      -After the Audit

Pre Audit Documents:
-The collection, collation and analysis of relevant information is an essential prerequisite for successfully planning a quality audit.
-In pre Audit document following documents are involved.
-Pre Audit Reports
-Agreed corrective action
-Product specific information
-General information about the company to be audited (external),
Pre-Audit Questionnaire
-Document requesting general information for the preparation of the auditors according to audit plan
-Audit schedule

During the Audit
-During audit all documents shall be easily available.
-The document includes products related, system and facility related documents, documents related to quality management system.

After the Audit
-After completion Audit report will be prepared by the auditor.
-Auditee has to respond to the audit findings by how the observations will be dealt with.
-It also may be possible that the auditee disagrees with an observation in which case the auditee management must take a decision.

No comments:

Post a Comment