SOP for Batch Releas Procedure

Prepared by： X X
Department Name Date

Approved by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date

1. Purpose

The purpose of this SOP is to explain procedures for evaluation of batch documents and
release for sale.
2. Scope

This SOP is to be followed by the Quality Assurance manager for checking batch
documents and release products for sale.

3. Validity

This SOP is valid up to the next revision date and only if it bears the control seal.

4. Responsibility

It is the responsibility of Quality Assurance Manager to check the full implementation of

this SOP.

5. Materials and Equipment

Filled Batch Manufacturing records (BMR), Product release stamp(RELEASED,

REJECTED),

6. Procedure

6.1. Check all phases/required procedures are completed and signed off by authorized
production person. Check for correctness and completeness of the Batch Manufacturing
Records (BMR) and relevant entries are made in accordance with Good Manufacturing
Practices documentation rules.
6.2. BMR must be readable and understandable.
6.3. Check the following entries are matching with the respective Finished Product
Specification
 Batch number (BN)
 Batch number format and coding on all packing components.
 Expiry Date format and coding on all packing components.
 Correct product name and product number
 Line clearance and cleaning entries are made properly and signed off.
 All in-process checks are carried out according to procedure and signed off.
  Check whether all quality control tests such as Assay, Sterility and pyrogen tests
are performed and complied for the finished products.
6.4. Check the packaging Artworks are matching with the respective Packaging Material
Specification.
 Correct product name on the packaging samples.
 Correct storage condition and temperature is printed.
 Other relevant artworks are matching with the customer specification.
6.5. Check the Reconciliation Sheet is correctly filed up with quantity received, quantity
used and quantity returned for each raw material and packaging component. Check the
reconciliation calculation for the raw material, finished product and packaging
components are correct and within the limit.
6.6. Check all in -process and finished product testing were done according to Finished
Product Specifications and Test Report.
6.7. Retention samples are correctly checked and managed.
6.8. Batch documentation checklist is correctly checked, filled up and signed by both
authorized production staff and QA
6.9. Staff.
6.10. IPQA Inspection Sheet is correctly filled up, signed and no data has inconsistency or
no test result is outof specification.
6.11. All Deviation Reports raised were successfully completed, corrective actions are
implemented and preventative actions are listed.
6.12. If all the actions are meeting the in -house and regulatory requirements, the quality
assurance manager will sign the Batch Document Checklist to release the batch.
6.13. The Quality assurance manager will inform the warehouse the list of products
approved for sales using Released Products Notification Formand retain a copy.
6.14. For any unsuccessful inspection or nonconformance, Quality assurance manager will
hold the batch before the non-conformance is investigated and the assignable cause will
be determined.
6.15. For any critical or serious defect or non –conformance, Quality assurance manager
will reject the batch by stamping a “RED reject stamp” on the check list and sign the
 form. Appropriate number of reject stickers will be produced and signed and send to
warehouse to stick those onto rejected pallets.

7. Abbreviations:
 SOP Standard Operating Procedure
8. Related Documents /Applicable document/
None
9. Revision History

Version
Revision Description
No.
1 New