033- SOP on Batch Release System

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 : Review of analysis and batch manufacturing :

Executive / Officer- QC. Executive / Officer-QA

record. Release / Reject of the Batch

Head-Quality / Manager-QA

4.0 Accountability: 5.0 Procedure

5.1

:

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

: 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.

5.1.6 SOP/QA001/F01-00

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

Title: SOP on Batch Release System

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:

7.0

Abbreviation

Expanded Form

F

Format

SOP

Standard Operating Procedure

QA

Quality Assurance

NA

Not Applicable

Forms and Attachments: Annexure-1 : Batch release note

8.0

Distribution List: S.No. 1. 2.

SOP/QA001/F01-00

Department Name Quality Assurance Quality Control

No. of Copy 01 01

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 Date Control sample withdrawn: Quantity Released : Remarks :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