Review System for Documents

1.0 OBJECTIVE

To lay down a procedure for review system of documents. 

2.0 SCOPE

This procedure is applicable review system of documents at XXX, Company. 

3.0 RESPONSIBILITY

3.1 Heads- all departments   

4.0 PROCEDURE  

4.1 All the documents produced during manufacturing shall be review by quality assurance department and relevant departments.  

4.2 SOPs, Specifications & Test Procedures, Master Formula Records, BMR preparation, Site Master File, Master Validation plan, Qualification Documents shall be reviewed by the Quality assurance department and other respective departments as per document control SOP.

4.3 Validation protocols namely process validation, cleaning validation and method validation protocols are reviewed by the Quality assurance department and other respective departments as per document control SOP.

4.4 Completed Batch manufacturing records shall be reviewed by quality assurance executive as per SOP.

4.5 Data generated during the chemical analysis of the samples namely work sheets shall be review by quality assurance. 

4.6 Data generated during the microbiological analysis of the samples namely work sheets shall be review by quality assurance. 

4.7 All log books generated during production shall be counter signed by IPQA personnel. 

4.8 Log books for water plant shall be counter signed by QA personnel.

4.9 Log books for AHU’s shall be counter signed by QA personnel 

5.0 ABBREVIATIONS

5.1 SOP-Standard Operating procedure

6.0  ANNEXURE : Nil

7.0  CHANGE HISTORY