Batch release procedure for finished products for sale

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2 years ago

Batch release procedure for finished products for sale

1.0 OBJECTIVE:
1.1 To lay down a procedure for approval and release of finished products for sale.

2.0 SCOPE:
2.1 This Standard Operating Procedure (SOP) is applicable for approval and release of finished products for sale manufactured at ABC Pharma

3.0 RESPONSIBILITY:
3.1 Production Manager / his designee shall responsible to manufacture the batch as per the approved manufacturing procedure, correctly complete the BMR & BPR and forward to QA department for their review.
3.2 Quality Assurance Officer / Executive shall be responsible for review the records.
3.3 QA Manager / his designee shall be responsible for approval and release of finished product for sale/distribution through Pharmasuit system.
3.4 Head-QA shall be responsible for compliance of this SOP.

4.0 ACCOUNTABILITY:
4.1 Head QA
5.0 PROCEDURE:
5.1 All the production records including for manufacturing, packing, labeling and analytical records shall be reviewed by Quality Assurance to determine compliance with all written, established and approved procedures before batch is released for distribution. If found any discrepancy shall not be dispatch without the investigation thoroughly and compliances to the finish good release specification.
5.2 Quality Assurance Officer / Executive ensure that batch quantity packed completely and inspected as per BMR/BPR.
5.3 Quality Assurance Officer / Executive ensure that all the used packing material reconcile properly and remaining returned to warehouse through material return note (MRN). The loose box label, online rejected printed and non-printed material and stereo destroyed properly.
5.4 Batch manufacturing record & batch packing record (BMR/BPR) must be reviewed by Manager Production / Designee. Manager Production shall ensure the batch manufactured and packed all parameter with in the limit as per BMR & BPR. Batch manufactured & packed in supervision of competent technical person.
5.5 Quality Assurance person shall review the batch manufacturing and packing records are fulfilled by production, checked by manager production and verified by QA at every stage of manufacturing and packing.
5.6 Any deviation, non-compliances, OOS observed during the stage of manufacturing and packing shall be closed and their impact shall be evaluated that there are no any impact to the product quality.

5.7 All the related analytical record of in process and finish goods should be complying to its acceptance criteria and established specification.
5.8 The analytical report should be enclosed with batch record (BMR/BPR) and the meet the criteria of its establish specification.
5.9 Batch records issued are appropriate and in accordance with the current and approved master copy of BMR/BPR.
5.10 Specimens of all labeling used in packing shall be signed by Packaging Supervisor and Quality Assurance Officer / Executive.
5.11 Each critical step in the manufacturing, packing and processing is witnessed by the other person as indicated in batch manufacturing and packing records.
5.12 Quality Assurance shall review that all the record are in accordance to the Batch Release check list (refer Annexure-2) and complying to the analytical records as per specification and ensure that quantity packed are as per Transfer Ticket.
5.13 Batch Analytical Records:
5.13.1 All the analytical reports with protocols from relevant sections (e.g. chemical, microbiological etc.) are enclosed.
5.13.2 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.
5.13.3 All the supporting analytical documents (e.g. Chromatograms, U.V. absorbance print out, IR Spectra, public analytical report etc.) are enclosed to the respective analytical documents. The supporting analytical documents shall be signed by analyst and checked by the laboratory supervisor or in-charge.

5.13.4 A certificate of analysis is enclosed with remarks / opinion of Manager-Quality Control and signature of analyst and Manager – Quality Control.
5.14 Rejection / Approval of Batch Release :
5.14.1 Production officer / Executive shall prepare the finished goods transfer note. The finished goods transfer note shall be checked by QA Officer/Executive.
5.14.2 After completion of review of BMR and BPR by Production and QA Officer/ Executive and review of batch analytical report shall forward the reviewed BMR, BPR and analytical report to QA Manager/Designee for final product approval and release.
5.14.3 QA personnel shall fill the “Batch Release Slip” in duplicate and shall forward the same to QA Manager along with the batch manufacturing record and analytical record.
5.14.4 QA Manager or his/her designee shall sign the “Batch Release Slip” with date and release the finished product through Pharmasuit system, one copy of batch release slip shall be forwarded to warehouse and another copy shall be filled along with batch record.
5.14.5 The product release shall be communicated to warehouse through “Batch Release Slip”
(refer Annexure -1)

6.0. ABBREVIATION:

S. No.	Abbreviations used	Full form of Abbreviation used
1.	SOP	Standard Operating Procedure
2.	QA	Quality Assurance
3.	BMR	Batch Manufacturing Records
4.	BPR	Batch Packing Records

7.0. ATTACHMENTS (ANNEXES):
Annex-I : Batch Release Slip
Annex-II : Batch Release Checklist

8.0 REFERENCE :

S. No.	Reference Title
1.0	Schedule M of Drugs and Cosmetics Act

Annex-I :

Batch Release Slip

BATCH RELEASE SLIP

PRODUCT NAME :

BATCH NO.:

MFG. DATE:

EXP. DATE:

MARKET:

PACK SIZE:

PACKED QUANTITY FOR RELEASE:

DATE OF RELEASE:

This is to certify that above product has been manufactured, tested a

nd 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 requirement of both, the product authorization and the manufacturing license has been met.

RELEASED BY:

Sign/Date
MANAGER QA / DESIGNEE

Annex-II

Batch Release Checklist

S. No.	Review Parameters	Reviewed *	Reviewed by	Remark (In case any abnormality)
1.0	Batch Manufacturing Record (BMR)
1.1	BMR Issuance Record
1.2	Material Issuance Record
1.3	Whether each manufacturing step was followed
1.4	IPQC tests performed
1.5	Review of yield at appropriate stages
2.0	Batch Packing Record (BPR)
2.1	BPR Issuance Record
2.2	Packaging materials issuance Record
2.3	Whether each packaging step was followed
2.4	Packing material reconciliation
2.5	IPQC Inspection
2.6	Packed in accordance with packaging instruction
3.0	Batch Analytical Records
3.1	Supporting Analytical Data
3.2	Analysis as per current version of analytical method
3.3	Attachments (e.g. Chromatograms, spectra, external lab report etc.)
3.4	Certificate of analysis in accordance with specification.
4.0	Review of environmental data
5.0	Water analysis
6.0	Random physical inspection of batch samples including secondary packing & shipping marks
8.0	Review of deviation, if any
9.0	Reference samples / Other sample