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GMP Documentation and Record-Keeping Audit Checklist

A specialized audit checklist focusing on GMP documentation and record-keeping practices in pharmaceutical manufacturing, ensuring compliance with regulatory requirements and maintaining data integrity.

GMP Documentation and Record-Keeping Audit Checklist

by: audit-now
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About This Checklist

Effective documentation and record-keeping are cornerstones of Good Manufacturing Practice (GMP) compliance in the pharmaceutical industry. This GMP Documentation and Record-Keeping Audit Checklist is an indispensable tool for ensuring that all aspects of pharmaceutical manufacturing are properly documented, from raw material receipt to finished product release. By focusing on the critical area of documentation, this checklist helps pharmaceutical companies maintain data integrity, traceability, and compliance with regulatory requirements. It addresses common pain points such as incomplete records, data inconsistencies, and inadequate document control, ultimately contributing to improved product quality and patient safety.

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Industry

Healthcare

Standard

Good Manufacturing Practices (GMP)

Workspaces

Pharmaceutical Manufacturing Facilities

Occupations

Quality Assurance Specialist
Documentation Specialist
GMP Auditor
Regulatory Compliance Officer
Records Manager
1
Are all Standard Operating Procedures (SOPs) current and accessible to relevant personnel?
2
Are batch records completed accurately and in a timely manner?
3
What is the frequency of document control reviews (in months)?
Min: 1
Target: 6
Max: 12
4
Has a recent data integrity assessment been conducted?
5
What compliance issues have been identified in the last audit?
6
Are all personnel trained on the relevant SOPs and documentation practices?
7
What was the date of the last document review?
8
What is the record retention period for batch records (in years)?
Min: 1
Target: 2
Max: 10
9
Is the document control system being used effectively?
10
What recommendations do you have for improving documentation practices?
11
Have all previous audit findings related to documentation been addressed?
12
Is documentation easily accessible to all relevant personnel?
13
What is the average error rate in documentation (percentage)?
Min: 0
Target: 5
Max: 100
14
When is the next scheduled training for documentation practices?
15
What challenges have been encountered in maintaining documentation?
16
Is there a documented change control process in place for SOPs?
17
How often are documentation audits conducted (in months)?
Min: 1
Target: 3
Max: 12
18
Are electronic signatures used for critical documentation?
19
When was the last training session on documentation conducted?
20
What best practices for documentation are currently followed?
21
Is there a formal document review process established?
22
How frequently are documentation updates made?
23
What is the current training completion rate for documentation practices (percentage)?
Min: 0
Target: 90
Max: 100
24
Is version control implemented for all critical documents?
25
What lessons have been learned from past documentation challenges?

FAQs

The checklist covers various GMP-related documents including standard operating procedures (SOPs), batch records, equipment logs, training records, and quality control documentation.

It includes specific items to verify the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) in both paper and electronic records.

Yes, the checklist is designed to audit documentation practices in both traditional paper-based systems and modern electronic document management systems.

It's recommended to conduct a thorough documentation audit at least bi-annually, with more frequent spot-checks on critical documentation processes.

Typically, the audit is conducted by quality assurance personnel, internal auditors, or designated documentation specialists within the pharmaceutical company.

Benefits of GMP Documentation and Record-Keeping Audit Checklist

Ensures comprehensive review of all GMP-related documentation practices

Helps identify gaps in record-keeping processes and data integrity

Facilitates compliance with regulatory requirements for documentation

Improves traceability and accountability in pharmaceutical manufacturing

Supports data-driven decision making and continuous improvement