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Pharmaceutical Document Control Checklist

Ensure compliance and maintain impeccable records with our Pharmaceutical Document Control Checklist. Streamline your processes, minimize errors, and confidently meet regulatory requirements. Download now and strengthen your pharmaceutical documentation practices!

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Document Creation & Approval

1 of 8

Ensuring proper authorization and version control during document creation.

Document Title

Document Purpose/Scope

Document Type (SOP, Form, Report, etc.)

Document Classification (Confidential, Public, etc.)

Date of Creation

Document Version Number

Author Signature

Reviewer Signature

Document Review & Revision

2 of 8

Verification of accuracy and completeness by designated personnel.

Review Date

Reviewer Role

Review Comments/Observations

Revision Number (if applicable)

Review Result

Reviewer Signature

Approval Date (if approved)

Document Distribution & Access

3 of 8

Controlled distribution and limited access to approved documents.

Distribution Method

Recipients (Document Distribution List)

Distribution Notes/Comments

Date of Distribution

Distribution Acknowledgement

Document Storage & Retention

4 of 8

Secure and compliant storage of all documents for the required retention period.

Total Number of Documents Stored

Last Storage System Review Date

Physical Storage Location (if applicable)

Description of Storage Conditions (e.g., temperature, humidity)

Retention Period (Years)

Document Destruction Start Date (if applicable)

Storage Media Type (Electronic/Physical)

Document Retrieval & Availability

5 of 8

Ensuring readily available access to necessary documents when required.

Date of Last Document Retrieval

Document Retrieval Purpose/Reason

Retrieval Method (e.g., Electronic, Paper)

Number of Documents Retrieved

Location of Document Retrieval (e.g., Server, Archive)

Time of Retrieval

Obsolete Document Control

6 of 8

Proper identification and removal of obsolete documents from circulation.

Date of Document Identification as Obsolete

Reason for Document Obsolescence

Description of the reason for obsolescence

Upload Document for Review (Optional)

Document Status Post-Obsolescence

Reviewer Signature

Document ID

Change Management (Documents)

7 of 8

Tracking and documenting all changes made to controlled documents.

Change Request Date

Reason for Change

Detailed Description of Change

Affected Document(s)

Document Revision Number (Before Change)

Document Revision Number (After Change)

Supporting Documentation

Preparer Signature

Reviewer Signature

Document Master Record (DMR) Review

8 of 8

Verification and approval of DMRs for manufacturing processes.

DMR Review Date

DMR Version Number

Review Status

Review Comments/Observations

Reviewer Signature

Deviation Identified?

Supporting Documentation (if applicable)

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