Audit Plan
Audit Number
Company Name
Audit Site
Scheduled Date of Audit
Scheduled Auditor Name
Auditor Contact
Information
I. Purpose:

To review the project management, process development, analytical, and
manufacturing processes that will be used to make products under Good
Manufacturing Practices

Confirm applicable policies and standard operating procedures are
followed.

Ensure procedures and practices comply with cGMP Title 21, parts 210
and 211 and applicable ICH Guidelines.

Process development, stability, analytical and manufacturing
II. Scope:
III. Date of Audit:

Confidential
Day/Month/Year
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IV. Agenda
List items you expect to review during the audit - for example, Current Organizational
Charts, previous FDA/Regulatory Inspections, EIRs, FDA-483’s, Warning Letters etc.
Example List:
 Introduction
o Orientation
o Company Overview
 Pharmaceutical Development History
 FDA/Regulatory Inspections (e.g, Health Canada, EMEA) History
 EIR’s, FDA-483’s, Warning Letters, including Health Canada, EMEA, Responses
 Tour of Facility: Materials Handling Area(s), Development Laboratory, Sterile
Manufacturing Suite (e.g., Lyophilizer Area), Analytical Laboratories and
Stability Chambers
 Media Fills – How they are handled? History/Results
 Review of CAPAs
 Review of Change Change Controls
 Review of Lyophilizer Validation, including Protocol
 Calibration and Qualification Package for Vial Crimper
 Vial Filler Qualification/Validation Package
 Review of Training Records
 Closing Discussion
o Review of documents
o Interviews
o Summarized findings
o Next steps
V. Documents Requested prior to Audit
List any documents you would like the audit site to send prior to the audit.
Examples List:




Equipment List
Regulatory Inspection History
EIR’s, FDA-483’s, Warning Letters, including Health Canada, EMEA, Responses
SOPs
o Gowning (1016)
o Description of Plant 1 (1010)
o Change Control Procedure (1005)
o Out-of-Specifications Investigations (1021)
o CAPA (1029)
o Training (2002)
o Cleaning Validation (9001, 9004, 9007, 9008, 1015, 1020)
o Monitoring of Particulate Matter, Microorganisms, and Airflow Velocity
(1014)
Confidential
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