SOP for Documentation and Data Control : Pharmaceutical Guidelines

SOP for Documentation and Data Control

Standard operating procedure for approval and control of the documents in the quality assurance and other departments.

1.0 OBJECTIVE

To provide the guidelines for the Documents & Data Control.

2.0 SCOPE

Applicable in the QA department for the Documents & Data Control.

3.0 RESPONSIBILITY

QA Executive/ QA Chemist

4.0 ACCOUNTABILITY

QA Manager

5.0 PROCEDURE

5.1 "Controlled" Document: The stamp on the 'Controlled' document shall actually read as "CONTROLLED WHEN IN RED" as included in the specimen stamp. This shall rule out the possibility of a photocopy being used as "Controlled" documents.
5.2 "Master Copy": 
1) Original copy of the documents shall be signed in original by concerned.
2) It shall bear "Master Copy" stamp and it shall remain in the custody of QA Manager.
5.3 NATURE OF CONTROL
The controlled document shall have the following details:
  1. The effective date of SOP/ Revision status.
  2. Signature of the approving personnel/ authorized by.
  3. "CONTROLLED WHEN IN RED" stamp.
5.4 Document and Data Approval and Issuance:
  1. Each document or data shall be verified / checked for correctness and approved by authorised personnel prior to their issue and implementation.
  2. Controlled circulation list for each "Controlled" document shall be maintained.
  3. Master list of all "Controlled" documents showing their latest revision status shall be maintained with Quality Assurance Manager with a copy to the concerned managers Master Copy of each controlled document shall be maintained in the safe custody of QA Manager at Quality Division.
5.5 Documents and Data changes pertaining to production, process and control procedures :
These changes shall be implemented through "Change Control System" SOP :
Changes to the document and data shall be reviewed and approved by the change control committee as per SOP.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 QA: Quality Assurance





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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