Restricted Circulation
Ipca Laboratories Limited, Unit-II (Dehradun)
Standard Operating Procedure
Dept: Quality Assurance
SOP No. : DDC/QAD/021/2008/R00
TITLE: BATCH RELEASE
Supercedes :Nil
Page No. : 1 of 11
Issue Date Effective Date Review Date
22/05/2008 25/05/2008 24/05/2010
1.0 OBJECTIVE:
To lay down the procedure to be followed for release of a batch of the product.
2.0 SCOPE:
This procedure is applicable to all the products manufactured at the location.
3.0 RESPONSIBILITY:
3.1 Officer/Executive - QA is responsible for the preparation of Batch Release.
3.2 Manager- QA or his authorized nominee is responsible for batch release.
4.0 ACCOUNTABILITY:
Head-Q.A
5.0 PROCEDURE:
5.1 BATCH RECORD AUDIT:
5.1.1 Manager Quality Assurance / Quality Assurance Officer/Q.A. Inspector shall
review and check the following records for their correctness and compliance:
5.2 BATCH MANUFACTURING RECORD.
5.2.1 Issue of batch Manufacturing records formats by Quality Assurance with signature
and date of issue.
5.2.2 Batch Manufacturing records issued are appropriate and in accordance with the
current and approved Master copy of Batch manufacturing record.
5.2.3 Each significant step in the manufacturing, processing is accomplished including
Prepared By Checked By Approved By
Sign
Date
Name Amit Kumar Santosh Gupta Anurag Gupta
Department QA QA Head QA
Format No.DDC/QAD/001/001/R00
Restricted Circulation
Ipca Laboratories Limited, Unit-II (Dehradun)
Standard Operating Procedure
Dept: Quality Assurance
SOP No. : DDC/QAD/021/2008/R00
TITLE: BATCH RELEASE
Supercedes :Nil
Page No. : 2 of 11
Issue Date Effective Date Review Date
22/05/2008 25/05/2008 24/05/2010
dates and identity of major equipment’s meet.
5.2.4 Specific identification of each Material of the batch.
5.2.5 Components used during the processing or manufacturing are weighed correctly
and weighing operation witnessed by the other person.
5.2.6 In process Quality Control checks and results.
5.2.7 Process control checks and results.
5.2.8 Calculations of yields at appropriate phases of manufacturing or processing and the
percentage of theoretical yield and limits established and indicated in BMR.
5.2.9 The other person as indicated in Batch Manufacturing Records witnesses each
critical step in the manufacturing and processing.
5.2.10 If any Deviation done in the process, it shall be documented and investigated.
5.3 BATCH PACKING RECORDS:
5.3.1 Issue of batch packing record by Quality Assurance with the signature and date of
issue.
5.3.2 Batch packing record formats issued are appropriate and in accordance with the
current and approved Master copy.
5.3.3 Inspection of the packing and labeling area before use & line clearance by QA.
Prepared By Checked By Approved By
Sign
Date
Name Amit Kumar Santosh Gupta Anurag Gupta
Department QA QA Head QA
Format No.DDC/QAD/001/001/R00
Restricted Circulation
Ipca Laboratories Limited, Unit-II (Dehradun)
Standard Operating Procedure
Dept: Quality Assurance
SOP No. : DDC/QAD/021/2008/R00
TITLE: BATCH RELEASE
Supercedes :Nil
Page No. : 3 of 11
Issue Date Effective Date Review Date
22/05/2008 25/05/2008 24/05/2010
5.3.4 Actual yield and percentage of theoretical yield at appropriate phases of operations
as indicated in batch packing records.
5.3.5 Reconciliation records.
5.3.6 Specimens of all packing components used in packing and signed by packaging
supervisor and Quality Assurance Inspector.
5.3.7 Description of product containers and closures used with their identification.
5.3.8 Signature of persons performing and supervising or checking each significant step in
the operation.
5.3.9 Results of examinations made as per "Product Inspection" report.
5.3.10 Any investigation made there of.
5.4 If any Deviation done in the process, it shall be documented and investigated.
5.5 After auditing the Batch Manufacturing Records, Batch Packing Records, analytical
records, and inprocess samples, Manager Quality Assurance or his designated
nominee shall release / reject the batch and sign with date on the batch records.
5.6 Investigation record shall be prepared if any unexplained discrepancies or the failure
Prepared By Checked By Approved By
Sign
Date
Name Amit Kumar Santosh Gupta Anurag Gupta
Department QA QA Head QA
Format No.DDC/QAD/001/001/R00
Restricted Circulation
Ipca Laboratories Limited, Unit-II (Dehradun)
Standard Operating Procedure
Dept: Quality Assurance
SOP No. : DDC/QAD/021/2008/R00
TITLE: BATCH RELEASE
Supercedes :Nil
Page No. : 4 of 11
Issue Date Effective Date Review Date
22/05/2008 25/05/2008 24/05/2010
of a batch or any of its components to meet any of the specification with conclusion
and follow up.
BATCH ANALYTICAL RECORDS:
Batch Analytical Records shall be randomly reviewed for the following:
5.8.1 All the analytical reports with protocols from relevant sections are enclosed.
5.8.2 All the analytical reports with protocols are duly signed by analyst and certified by
Manager Quality Control with his opinion / remarks on the tests carried out.
5.8.3 All the supporting analytical documents are enclosed with the respective analytical
reports.
5.8.4 Dates are entered at appropriate places with signatures.
5.8.5 Certificates of analysis with remarks / opinion of Analyst and signature of analyst and
Manager Quality Control.
5.9 It shall be ensured that appropriate control samples of Final Product, shall be retained
as per SOP of control samples.
5.10 It shall be verified that a cross-reference to environmental monitoring data is available.
5.11 Batch Manufacturing Records and Batch Packing Records shall be complied together
batch wise.
Part Batch Release:
Prepared By Checked By Approved By
Sign
Date
Name Amit Kumar Santosh Gupta Anurag Gupta
Department QA QA Head QA
Format No.DDC/QAD/001/001/R00
Restricted Circulation
Ipca Laboratories Limited, Unit-II (Dehradun)
Standard Operating Procedure
Dept: Quality Assurance
SOP No. : DDC/QAD/021/2008/R00
TITLE: BATCH RELEASE
Supercedes :Nil
Page No. : 5 of 11
Issue Date Effective Date Review Date
22/05/2008 25/05/2008 24/05/2010
6.1 Part release for export products shall be considered only under following conditions:
6.1.1 Export order quantity is less than the standard batch quantity and no further export
order is currently pending for that product.
6.1.2 Dispatch of packed quantity under one export order gets delayed because of
unavailability of packing material for balance quantity of another export order for the
same batch.
6.1.3 When quantity for sale is packed and the rest quantity to be packed as Physician
Sample (PS) is likely to take more than 3 days.
6.2 Part release for Domestic products can be given only under following condition:
6.2.1 When sale quantity is packed and rest quantity to be packed as Physician Sample
(PS) is likely to take more than 3 days.
6.2.2 When part of the batch is packed as physician sample and the rest quantity to be
packed as sales pack cannot be packed immediately due to unavailability of packing
material.
6.3 6.3 Request for part release shall be initiated by in charge of finished goods stores as
6.4 per Annexure I Format No. DDC/QAD/021/003 and forward the same to packing
officer.
6.4 Packing officer shall fill up the details of packed and unpacked quantities of 6.5the
batch in the format and forward it to QA officer after signing by Head Packing /
Designee.
Prepared By Checked By Approved By
Sign
Date
Name Amit Kumar Santosh Gupta Anurag Gupta
Department QA QA Head QA
Format No.DDC/QAD/001/001/R00
Restricted Circulation
Ipca Laboratories Limited, Unit-II (Dehradun)
Standard Operating Procedure
Dept: Quality Assurance
SOP No. : DDC/QAD/021/2008/R00
TITLE: BATCH RELEASE
Supercedes :Nil
Page No. : 6 of 11
Issue Date Effective Date Review Date
22/05/2008 25/05/2008 24/05/2010
6.6 QA officer shall verify the details written in the format and if found correct forward the
same format to QC manager after auditing of BMR and the corresponding BPR.
6.7 QC manager shall check the details for analytical compliance of the batch and if
found complying, puts his approval as “Conforms” in the format.
6.8 The format shall be finally submitted to Plant Head /designee and Head QA /
designee for final approval of the part release.
6.9 On approval of the part release, one copy of the approved format shall be given to
finished goods store, one copy to quality control and the original copy shall be
attached with the respective BPR.
6.10 Final batch release note shall be prepared after final review of COA & batch records
after completion of packing.
Reference of this SOP is taken from SOP No. DDN/QAD/029/2006/R00 &
DDN/QAD/017/2006/R00
ABBREVIATION(S) :
QAD : Quality Assurance Department
QC : Quality Control
FGS : Finished Goods Store
SOP : Standard Operating Procedure
BMR : Batch Manufacturing Record
BPR : Bach Packing Record
Mfg. : Manufacturing
Exp. : Expiry
Prepared By Checked By Approved By
Sign
Date
Name Amit Kumar Santosh Gupta Anurag Gupta
Department QA QA Head QA
Format No.DDC/QAD/001/001/R00
Restricted Circulation
Ipca Laboratories Limited, Unit-II (Dehradun)
Standard Operating Procedure
Dept: Quality Assurance
SOP No. : DDC/QAD/021/2008/R00
TITLE: BATCH RELEASE
Supercedes :Nil
Page No. : 7 of 11
Issue Date Effective Date Review Date
22/05/2008 25/05/2008 24/05/2010
COA : Certificate Of Analysis
ANNEXURE(S) :
Annexure I : Details of the batch for release
Annexure II : product release note
Annexure III : Format for Part release
RECORD(S) :
Sr. Name of Format No. Originator Retain Mode Of Filling
No. ed
Documents
By
1. Details of the DDC/QAD/021/ QA QA Product wise
batch for release 001/R00
2. Approval for part DDC/QAD/ QA/CQD QA Product wise
release of batch 021/003/R00
Prepared By Checked By Approved By
Sign
Date
Name Amit Kumar Santosh Gupta Anurag Gupta
Department QA QA Head QA
Format No.DDC/QAD/001/001/R00
Restricted Circulation
Ipca Laboratories Limited, Unit-II Dehradun
Standard Operating Procedure
DEPT: Quality Assurance
Ref. No. : DDC/QAD/021/2008/R00
TITLE: BATCH RELEASE
Supercedes :Nil
Page No. : 8 of 11
Issue Date Effective Date Review Date
20/05/2008 23/05/2008 22/05/2010
ANNEXURE-I
Format No. DDC/QAD/021/001/R00
Details of the batch for release
Product Name:
Batch Date
S. Batch A.R.No Release Sale/ Releas EPO Batch
size Mfd Exp of Remarks
No. No . qty. P.S e date No. yield
tabs/lts COA
ANNEXURE-II
Prepared By Checked By Approved By
Sign
Date
Name Amit Kumar Santosh Gupta Anurag Gupta
Department QA QA Head QA
Format No.DDC/QAD/001/001/R00
Restricted Circulation
Ipca Laboratories Limited, Unit-II (Dehradun)
Standard Operating Procedure
Dept: Quality Assurance
SOP No. : DDC/QAD/021/2008/R00
TITLE: BATCH RELEASE
Supercedes :Nil
Page No. : 9 of 11
Issue Date Effective Date Review Date
22/05/2008 25/05/2008 24/05/2010
Format No. DDC/QAD/021/002/R00
PRODUCT RELEASE NOTE
To,
PRODUCTION DEPARTMENT / FG STORE
PRODUCT : MFG. DATE : :
BATCH No. : EXP. DATE :
BATCH SIZE : A.R. No. :
BSR TRANSFER DETAILS
S. Packing
Pack Size/Date No. of unit transfer Pack Size Sale/Phy. Sample
No. Slip No.
1.
2.
3.
REMARKS :
DATE : Q.A. MANAGER
Prepared By Checked By Approved By
Sign
Date
Name Amit Kumar Santosh Gupta Anurag Gupta
Department QA QA Head QA
Format No.DDC/QAD/001/001/R00
Restricted Circulation
Ipca Laboratories Limited, Unit-II (Dehradun)
Standard Operating Procedure
Dept: Quality Assurance
SOP No. : DDC/QAD/021/2008/R00
TITLE: BATCH RELEASE
Supercedes :Nil
Page No. : 10 of 11
Issue Date Effective Date Review Date
22/05/2008 25/05/2008 24/05/2010
ANNEXURE-III
Format No. DDC/QAD/021/003/R00
Approval for Part Release of Batch
Part A: To be filled in by In charge Finished Goods Stores.
Batch
Product : :
No.
Mfg. date : Exp. date :
Export Order Number Quantity required Customer
Total Quantity: In charge FGS :
(Sign. / Date )
Part B: To be filled by Packing officer & QA Officer.
Qty. Transferred
Std. Batch Reason for Part
To Qty. Packed Balance Qty.
Size Release
Packing
Cont…..
Reconciliation of Quantity Checked Head Packing / Designee BMR / BPR review
by by QA
Prepared By Checked By Approved By
Sign
Date
Name Amit Kumar Santosh Gupta Anurag Gupta
Department QA QA Head QA
Format No.DDC/QAD/001/001/R00
Restricted Circulation
Ipca Laboratories Limited, Unit-II (Dehradun)
Standard Operating Procedure
Dept: Quality Assurance
SOP No. : DDC/QAD/021/2008/R00
TITLE: BATCH RELEASE
Supercedes :Nil
Page No. : 11 of 11
Issue Date Effective Date Review Date
22/05/2008 25/05/2008 24/05/2010
Pkg. officer IPQA officer
The above batch Conforms / Dose not conforms to Finished Product Specification.
_______________
Manager QC / Designee
(Sign / Date)
Conclusion : The above Part release is approved / rejected
Plant Head Head QA
Signature / Date Signature / Date
Prepared By Checked By Approved By
Sign
Date
Name Amit Kumar Santosh Gupta Anurag Gupta
Department QA QA Head QA
Format No.DDC/QAD/001/001/R00
Restricted Circulation
Ipca Laboratories Limited, Unit-II Dehradun
Standard Operating Procedure
Dept: Quality Assurance
SOP No. : DDC/QAD/021/2008/R00
TITLE: BATCH RELEASE
Supercedes :Nil
Page No. : 1 of 1
Issue Date Effective Date Review Date
22/05/2008 25/05/2008 24/05/2010
REVISION CARD
Revision Revision Revision Details Reasons for Approved By
Date NO. Page Ref Details of Revision
No. Point Revision
No.
Prepared By Checked By Approved By
Sign
Date
Name Amit Kumar Santosh Gupta Anurag Gupta
Department QA QA Head QA
Format No.DDC/QAD/001/001/R00
