Title: SOP on Batch Release System

1.0 Objective: To describe the procedure for Release / Rejection of drug products which are intended

for dispatch..

2.0 Scope: This procedure is applicable to the entire finished product manufactured at solrex

pharmaceuticals company

3.0 Responsibility:

Analysis of finished goods : Executive / Officer- QC.

Review of analysis and batch manufacturing

record.

: Executive / Officer-QA

Release / Reject of the Batch : Head-Quality / Manager-QA

4.0 Accountability: The Head-quality shall be accountable for the compliance of the system.

5.0 Procedure :

5.1 Following procedure to be followed for Batch Release:

5.1.1 Batch Manufacturing Records Review and Analytical document Review shall be

carried.

5.1.2 All the product records, including those for packing and labeling and

analytical records shall be reviewed to determine the compliance with the approved

procedures.

5.1.3 Any discrepancy or failure of batch or any of its components to meet any of its

specifications shall be investigated.

5.1.4 The data recorded in batch records shall be signed and certified by the responsible

supervisor.

5.1.5 It shall be ensured that appropriate retain samples of final product have been

retained as per SOP for handling of Control / Retention Samples.

SOP/QA001/F01-00

Title: SOP on Batch Release System

5.1.6 When Batch Records (Production, Packing & Analytical Records) are found

satisfactory after review, the batch shall be released by Head-Quality / Designee..

5.1.7 The release shall be conveyed to Production In-charge / Ware house in charge

through “Batch Release Note”. Batch Release Note shall be attached with

completed batch manufacturing record.

5.1.8 In case of rejection the "Rejected" stickers shall be affixed to every container or

drum holding the rejected material

6.0 Abbreviations:

Abbreviation Expanded Form

F Format

SOP Standard Operating Procedure

QA Quality Assurance

NA Not Applicable

7.0 Forms and Attachments:

Annexure-1 : Batch release note

8.0 Distribution List:

S.No. Department Name No. of Copy1. Quality Assurance 012. Quality Control 01

SOP/QA001/F01-00

Annexure-1

BATCH RELEASE NOTE

TO WHOM SO EVER IT MAY CONCERN

Following Product is Released for dispatch:

Product

Batch No.

Mfg. Date

Exp. Date

Control sample withdrawn:

Quantity Released :

Remarks :

Prepared By :

Date./ Sign:

This is to certify that above product has been manufactured, tested and packed according to the principle and

guidelines of Good Manufacturing Practices as laid down in Schedule M of Drugs and Cosmetics Act 1942

and that requirements of both the product marketing authorization and the manufacturing license has been met.

Checked & Released By:

Head – Quality Assurance / Designee

Signature/Date

SOP/QA033/F01-00