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Batch Release Procedure of Finished Product

Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply chain/distributors or C&F warehouses. 

Procedure for Finished Product Batch Release

1.0   PURPOSE:

    • To lay down the procedure for approval and release of the finished product batch.

2.0   SCOPE:

    • This Standard Operating Procedure is applicable for all batches of finished products manufactured at the pharmaceutical drug manufacturing plant.

3.0   RESPONSIBILITY – SOP FOR BATCH RELEASE:

    • Officer / Executive, QA / Production: responsible for reviewing the batch record for its completeness and accuracy.
    • Head-Production: For completion and review of BMR/ BPR for adequacy.
    • Head, QC / QM: For completion and review of analytical / microbiology records for adequacy.
    • QA (QC Compliance): For the review of Analytical / Microbiology Data (Hard copy / Soft Copy) along with COA.

Related: SOP for Analytical Data Review

    • Plant Head: Approval of requisition in case of conditional transfer of product.
    • Head – QA: Responsible for approval and release of the batch. Responsible for Approval of batch for conditional transfer.
    • DEFINITION (S)
    • Conditional transfer: The transfer of finished product from the manufacturing location to   Macleod’s Finished Goods Warehouse or Carrying and Forwarding Agents (C&F) prior release of the batch but not for sale and distribution.

4.0   PROCEDURE – SOP FOR BATCH RELEASE

    • Production shall submit Batch Manufacturing Record and Batch Packaging Record after review and approval by Production Officer/ Executive and final review of Head, Production to QA for onward review by Quality Assurance.

Related: SOP for BMR & BPR Review

    • IPQA personnel shall ensure that the control samples and other samples like stability /microbiology/ validation samples in a product have been collected as applicable.
  • Batch records Review:
    • On receipt of the batch records (both batch manufacturing and batch packing records), Officer/ Executive Quality assurance shall review the documents for any discrepancy or deficiency, which impacts the product quality/ customer safety or licensing compliance or marketing authorization.
    • The discrepancies shall be categorized as given below:

    • Critical Discrepancies:

    • Any discrepancies which have a direct impact on the quality of the product or safety of the consumer and any discrepancy which leads to batch rejection/ failure/ serious non-compliance to approved procedures shall be classified as a critical discrepancy…
    • These discrepancies shall be brought to the notice of Head-Quality Assurance.
    • These discrepancies may arise from a failure to carry out GMP / GLP, etc. in some form or another.
    • All critical discrepancies observed shall be investigated or corrected in consultation and agreement of Head, QA with Head- Production / QC. SOP titled “Corrective and Preventive Actions” shall be referred for detailed CAPA for such cases.
    • The release of a batch shall be based on the investigation findings/ closure of CAPA/ corrective action and the final decision shall be taken by Head, Quality Assurance.

    • Major Discrepancies:

    • These discrepancies may or may not have direct impact on the quality of the product or customer safety or the licensing commitment or marketing authorization.
    • These can be rectified in consultation of the QA / Production / QC / QM personnel.
    • All major discrepancies observed shall be investigated or corrected in consultation and agreement of Head, QA with Head- Production / QC. Any major deficiency prior to batch release.

    • Minor Discrepancies:

    • These discrepancies do not have direct impact on the quality of the product or customer safety or the licensing commitment or marketing authorization.
    • These can be rectified in consultation of the QA / Production / QC personnel.
    • The discrepancies are listed in Annexure-I (Review Record for BMR (Orals)), Annexure-II (Review Record for BPR (Orals)), Annexure-IV (Review Record for BMR (Injections)), Annexure-V (Review Record for BPR (Injections)), Annexure-VII (Review Record for Analytical / Microbiology Data).
    • Prior to batch release, BMR/ BPR/ analytical/ Microbiology data shall be scrutinized by Officer/ Executive QA for appropriateness and adequacy of the rectifications/ corrections made and shall make entries in the ‘Batch Review Checklist (Orals)’ (Annexure-III) and ‘Batch Review Checklist (Injections) (Annexure-VI)’.
    • Head-QA or his designee shall check the batch review checklist for any kind of critical or major or minor discrepancies.

    • If found acceptable, Head-QA or his designee shall release the batch for sale or distribution.

    • Head, QA, while certifying a batch for release, shall ensure that the batch of the concerned product complies with the requirements of the product registration/ registration dossier/ marketing authorization/license and all other requirements regarding the manufacture, quality control and batch release of pharmaceutical products for sale.
    • The batch release shall be done through Enterprise Resource Planning (ERP) Batch Release Module.
    • Relevant Batch documents and Finished Product Analytical data (stored AR No. wise) and shall be archived in the document storage room under the custody of QA.
    • If the conditional transfer of a batch is required, production shall raise the “Conditional Batch Transfer Initiation Slip” (Annexure- IX).
    • The initiator shall provide the reason for the conditional transfer.
    • The request shall be approved by HOD and Plant Head. Head, Quality Control shall provide the tentative date for the clearance of the batch.
    • Based on the reason for conditional transfer and the date provided head QC, conditional transfer evaluated by Head, Quality Assurance.
    • If approved, the consignment shall be transferred to warehouse/ C&F agents. 
    • The distribution of batches approved for conditional transfer shall be controlled by means of restricting the preparation of the sale invoice in ERP Module on Batch Hold/ Unhold (Refer to print screen of the module as Annexure-XI and Batch Release Module: Annexure-X).
    • The process shall be controlled by Head, Quality Assurance
    • Following the clearance of batch from QC and completion of batch release procedure Head, QA shall “UNHOLD” the batch in the ERP/another Software module (Annexure-X).

    • Conditional Release of Batch:

    • Conditional Transfer shall be permitted for batches manufactured and sold by the company for the India region only.
    • Products sold by another party (in India region) shall not be allowed for conditional transfer.
    • Conditional Transfer for such products shall be allowed through a planned deviation (refer SOP for “Handling of Deviations”) after approval from the contract giver.
    • Conditional Transfer is not permitted for products to be sent for export markets.
    • Transfer (conditional) for such products shall be allowed through a planned deviation (refer SOP for “Handling of Deviations”) after approval from the contract giver or distribution department of Macleods Pharmaceuticals Limited, as and where applicable.
    • Product recall shall be initiated in case of failure of a batch transferred on a conditional basis as per SOP for Product Recall.

5.0   ABBREVIATION (S) :

    • ERP: Enterprise Resource Planning
    • CAPA: Corrective and Preventive Action

6.0   ANNEXURE (S) – SOP FOR BATCH RELEASE :

    • Annexure-I:   Review Record for BMR (ORALS)

Product Name:

B. No.:                       

Batch Size :                   

Market:

Checking of Documents

  • Manufacturing Records
Categories of Discrepancies: (Batch Release)
1. Critical:  (SOP for Batch Release)
Line clearance from QA for any manufacturing stage is completed.

Yes / No/ NA
Any process deviations carried out without formal approval of Head, Quality Assurance.

Yes / No/ NA
Failure to carry out the cleaning of equipment/ area as per the approved procedure.

Yes / No/ NA
Unexplained or unapproved addition/deletion of extra/ required ingredients.

Yes / No/ NA
Calculation of API done as per the requirement of the Batch record

Yes / No/ NA
Any other discrepancy observed
Observation: Critical discrepancy are observed / not observed in BMR
2. Major:  (SOP for Batch Release)
Checking of weight for the active ingredients/ excipients and their addition is recorded.

Yes / No/ NA
Missing entries such as relative humidity, temperature, pH, QC results, LOD/ moisture/water activity, etc.

Yes / No/ NA
All dispensing labels/ in-process weight labels duly checked at each stage of processing by the Production and QA executives.

Yes / No/ NA
Missing signatures of production chemist/operators for critical activities such as dispensing, blending, mixing, drying, lubrication, compression, coating, filling, inspection, etc.

Yes / No/ NA
Yield reconciliation at various stages of processing areas requirements of BMR

Yes / No/ NA
Any other discrepancy observed:
Observation: Major discrepancy are observed / not observed in BMR
3. Minor:  (SOP for Batch Release)
One of the signatures missing, other than those referred under “Critical” category

Yes / No/ NA
Missing date in a sequential flow.

Yes / No/ NA
Overwriting.

Yes / No/ NA
Error due to the transcription of entries.

Yes / No/ NA
Leaving blank spaces instead of striking out the area or writing ‘NIL’ / ‘NA’.

Yes / No/ NA
Missing ancillary documents that are found later.

Yes / No/ NA
The omission of date at the start and end of processing.

Yes / No/ NA
Sample entry missing in the BMR

Yes / No/ NA
Any other discrepancy observed
Observation: Minor discrepancy faults are observed / not observed in BMR

 

Name of the reviewer (QA):                                                                          Sign & Date:        

Discrepancy Correction Form

FROM QUALITY ASSURANCE                                          DATE:
To PRODUCTION
Subject Discrepancies observed in the Batch Manufacturing Record
Product :
Batch No. :
Observations
Reviewed by QA (Sign & Date)

 

FROM :  PRODUCTION                                                        DATE:
To :  QUALITY ASSURANCE
Subject :  Actions are taken
Head- Production (Sign & Date)

 

Critical / Major/ Minor discrepancies reviewed and found corrected/ not corrected or

No Discrepancies observed

BMR accepted/ rejected

Head-QA (Sign & Date):

 

    • Annexure-II:   Review Record for BPR (ORALS)

Product Name             :_________________________

Batch No.                     :_________________________

Batch Size                   : _________________________

Market                          : _________________________

 Checking of Documents

  • Batch Packaging Records
Categories of Discrepancies:

1. Critical: (SOP for Batch Release)
Line clearance from QA for any packing stage is completed. : Yes / No/ NA
Any process deviations carried out without formal approval of Head, Quality Assurance. : Yes / No/ NA
Failure to carry out the cleaning of equipment/ area as per the approved procedure. : Yes / No/ NA
Un explained or unapproved addition/deletion of extra/ required packaging material. : Yes / No/ NA
Specimen of labels, foils, cartons, catch covers, overprinted material, shipper proofs, etc. duly signed by Production and QA taken at the time of each step of the packaging process. : Yes / No/ NA
Any other discrepancy observed
Observation: Critical discrepancy are observed / not observed in BPR

2. Major: (SOP for Batch Release)
The discrepancy in the printed packaging material reconciliation. : Yes / No/ NA
Missing entries such as relative humidity, temperature, leak test, pH, volume, etc. : Yes / No/ NA
All in dispensing labels/ process weight labels duly checked at each stage by the Production and QA executives. : Yes / No/ NA
 Missing signatures of production chemist/operators for critical activities overprinting/ coding, stereo reconciliation, batch reconciliation, packaging, etc. : Yes / No/ NA
Yield reconciliation at various stages of packing areas requirements of BPR : Yes / No/ NA
Any other discrepancy observed
Observation: Major discrepancy are observed / not observed in BPR

3. Minor: (SOP for Batch Release)
One of the signatures missing, other than those referred under “major” category : Yes / No/ NA
Missing date in a sequential flow. : Yes / No/ NA
Overwriting. : Yes / No/ NA
Error due to the transcription of entries. : Yes / No/ NA
Leaving blank spaces instead of striking out the area or writing ‘NIL’ / ‘NA’. : Yes / No/ NA
Missing ancillary documents that are found later. : Yes / No/ NA
The omission of date at start and end of processing. : Yes / No/ NA
Control sample/ other sample entry missing in the BPR : Yes / No/ NA
Any other discrepancy observed
Observation: Minor discrepancies are observed / not observed in BPR

 

    • Annexure-III: Batch Review Checklist (ORALS)

Product Name:                                  Batch No.:                                Market:

Sr. No. Documents Available Not available
1.      Manufacturing Record
2.      Packaging Record
3.      COA
4.      Completed “discrepancy correction form”
MANUFACTURING RECORD
Sr. No. Document Details Satisfactory Not satisfactory
1.      Batch details (Batch No., Mfg. date, Expiry date, batch size, etc.)
2.      Line Clearances
3.      Bill of material entry details
4.      Temperature and humidity records
5.      Stage wise reconciliation
6.      Deviation records, if any
7.      Weight cards at each stage of processing
8.      Cleaning Swab/rinse Reports, if applicable
9.      Cleaned Labels, if applicable

 

PACKAGING RECORD

Sr. No. Document Details Satisfactory Not satisfactory
1.      Batch details (Batch No., Mfg. date, Expiry date, batch size, etc.)
2.      Packaging material entry details
3.      Line clearances
4.      Dispensing labels
5.      In-process approval for coding, overprinting, etc.
6.      Temperature and humidity records
7.      Stage wise reconciliation
8.      Reconciliation of packaging material
9.      Deviation records, if any
10.    Finished goods transfer note
11.    Control Samples/ Stability Sample/ Miscellaneous Samples (…………………………..) collected and records
ANALYTICAL / MICROBIOLOGY DOCUMENTS
Sr. No. Document Details Satisfactory Not satisfactory
1. In-process Data & Reports
2. COA and Finished product reports
3. Microbiology report, if any

 

Checked By (Sign & Date):

Discrepancy observed/ Not observed in Batch Manufacturing Record/ Batch Packaging Record/ Analytical / Microbiology Documents. The Batch documents have been reviewed for Critical, major and minor discrepancies and found satisfactory/ not satisfactory.

Reviewer (QA) (Sign/ Date)

 

    • Annexure-IV: Review Record for BMR (Injections)

Checking of Documents

Manufacturing Records

Categories of Discrepancies:

1. Critical: (SOP for Batch Release)
Line clearance from QA for the manufacturing or packaging stage is complete. : Yes / No/ NA
Checking of weight and no. of containers of API and its addition is recorded. : Yes / No/ NA
Any process deviations carried out without formal approval of authorized persons. : Yes / No/ NA
Missing entries such as humidity, temperature, pressure differentials, QC results, area conditions, etc. : Yes / No/ NA
Failure to carry out cleaning and sanitization of done as per the approved procedure. : Yes / No/ NA
Un explained or unapproved addition/deletion of extra/ required ingredients. : Yes / No/ NA
Addition of drug substances without checking the quantity as per calculation in BMR. : Yes / No/ NA
Machine logs filled as per progress of operations. : Yes / No/ NA
Autoclave record including charts and indicator records available. : Yes / No/ NA
In-process checks like leaking test, weighting variation, etc. as applicable done. : Yes / No/ NA
Any other discrepancy observed:
Observation: Critical discrepancy are observed / not observed in BMR

2. Major: (SOP for Batch Release)
Missing signatures of production chemist/operators for critical activities such as dispensing, washing of vials, autoclaving procedures, visual inspections, filling, sealing, etc. : Yes / No/ NA
All in-process weight labels duly checked at each stage of processing by the production and QA executives. : Yes / No/ NA
Yield reconciliation at various stages of processing : Yes / No/ NA
Any other discrepancy observed
Observation: Major Discrepancies are observed / not observed in BMR

3. Minor: (SOP for Batch Release)
One of the signatures missing. : Yes / No/ NA
Missing date in a sequential flow. : Yes / No/ NA
Overwriting. : Yes / No/ NA
Error due to the transcription of entries. : Yes / No/ NA
Leaving blank spaces instead of striking out the area or writing ‘NIL’ / ‘NA’. : Yes / No/ NA
Missing ancillary documents that are found later. : Yes / No/ NA
The omission of date of start and end of processing. : Yes / No/ NA
Sample entry missing. : Yes / No/ NA
Any other discrepancy observed
Observation: Minor faults are observed / not observed in Batch Record

    • Annexure-V:  Review Record for BPR (Injections)

Checking of Documents

Packaging Records

Categories of Discrepancies:

1. Critical: (SOP for Batch Release)
Line clearance from QA for the packaging stage is complete. : Yes / No/ NA
Any process deviations carried out without formal approval of Head, QA : Yes / No/ NA
Failure to carry out cleaning and sanitization of equipment/ area is done as per the approved procedure. : Yes / No/ NA
Unexplained addition/deletion of extra/ required packaging component. : Yes / No/ NA
Specimen of labels, cartons/ catch covers, overprinted material, WFI label, etc. duly signed by Production and QA taken at each step of the packaging. : Yes / No/ NA
Any other discrepancy observed 
Observation: Critical discrepancy are observed / not observed in BPR

2.  Major :(SOP for Batch Release)
All dispensing/ in-process weight labels duly checked at each stage of processing by the production and QA executives. : Yes / No/ NA
Missing entries such as humidity, temperature, area conditions, etc. : Yes / No/ NA
The discrepancy in the printed packing material reconciliation : Yes / No/ NA
Machine logs filled as per progress of operations. : Yes / No/ NA
Yield reconciliation at various stages of packing as per requirements of the BPR : Yes / No/ NA
Missing signatures of production chemist/operators for critical activities overprinting/ coding, stereo reconciliation, batch reconciliation, packaging, etc : Yes / No/ NA
Any other discrepancy observed
Observation: Major discrepancy are observed / not observed in BPR

3. Minor: (SOP for Batch Release)
One of the signatures missing, other than those referred under “major” category : Yes / No/ NA
Missing date in a sequential flow. : Yes / No/ NA
Overwriting. : Yes / No/ NA
Error due to the transcription of entries. : Yes / No/ NA
Leaving blank spaces instead of striking out the area or writing ‘NIL’ / ‘NA’. : Yes / No/ NA
Missing ancillary documents that are found later. : Yes / No/ NA
The omission of date of start and end of processing. : Yes / No/ NA
Control sample/ other sampling entry missing in the register. : Yes / No/ NA
Any other discrepancy observed
Observation: Minor discrepancy are observed / not observed in BPR

 

Annexure-VI:  Batch Review Checklist (Injections)

Sr. No. Documents Available Not available
1.      Manufacturing Record
2.      Packaging Record
3.      COA
4.      Completed “discrepancy correction form”

MANUFACTURING RECORD

Sr. No. Document Details Satisfactory Not satisfactory
1.      Batch details (Batch No., Mfg. date, Expiry date, batch size, etc.)
2.      Line Clearances
3.      Bill of material entry details
4.      Temperature, differential, humidity records
5.      Equipment/Instrument print outs
6.      Pressure differential records
7.      Stage wise reconciliation
8.      Deviation records, if any
9.      Cleaning Swab / Rinse Reports, if applicable
10.    Cleaned Labels, if applicable
11.    Microbiology Report attached            Date of filling – –
Active Air Sampling Reports              Date :
Passive Air Sampling Reports            Date :
Sr. No. Document Details Satisfactory Not satisfactory
Personnel monitoring Reports (aseptic area) Name :

  • i.              …………………………….
  • ii.             …………………………….
  • iii.            …………………………….
  • iv.           …………………………….
  • v.            …………………………….
d. Surface Monitoring Report                          Date:
12.    Airborne non-viable particle count      Date:

PACKAGING RECORD

Sr. No. Document Details Satisfactory Not satisfactory
1.      Batch details (Batch No., Mfg. date, Expiry date, batch size, etc.)
2.      Packaging material entry details
3.      Line clearances
4.      Dispensing labels
5.      In-process approval for coding, overprinting, etc.
6.      Temperature and humidity records
7.      Stage wise reconciliation
8.      Reconciliation of packaging material
9.      Deviation records, if any
10.    Finished goods transfer note
11.    Control Samples/ Stability Sample/ Miscellaneous Samples (…………………………..) collected and records
ANALYTICAL / MICROBIOLOGY DOCUMENTS
Sr. No. Document Details Satisfactory Not satisfactory
1. In-process Data & Reports
2. COA and Finished Product reports
3. Microbiology report, if any
4. Sterility report

 

Annexure-VII: Review Record for Analytical / Microbiology Data

Review of Quality Control and Microbiology Data

Categories of Discrepancies:
1. Critical
Product tested as per Approved Specification of the product. : Yes / No/ NA
Product tested according to approved Standard test procedures. : Yes / No/ NA
All results are within specification. : Yes / No/ NA
All instruments used within defined calibration period : Yes / No/ NA
COA is available and correct. : Yes / No/ NA
Analytical / Microbiology data Hard copy is complying with Soft Copy
Any other discrepancy observed
Observation: Critical faults are observed / not observed in analytical reports
2. Major  
Balance print outs, IR graphs/ UV, chromatographs attached with reports. : Yes / No/ NA
Overwriting in weight and calculations adequately authorized. : Yes / No/ NA
Multiple entries without the signature of the doer or checker : Yes / No/ NA
All instruments identification nos. available on the analytical data sheet. : Yes / No/ NA
Multiple entries / missing date in a sequential flow. : Yes / No/ NA
Any other discrepancy observed
Observation: Major discrepancies are observed / not observed in analytical reports
3. Minor
Single signature missing : Yes / No/ NA
Missing date in a sequential flow. : Yes / No/ NA
Overwriting or error due to transcription of entries. : Yes / No/ NA
Leaving blank spaces instead of striking out the area or writing ‘NIL’ / ‘NA’. : Yes / No/ NA
Missing ancillary documents that are found later. : Yes / No/ NA
The omission of date at start and end of the analysis. : Yes / No/ NA
Any other discrepancy observed:
Observation: Minor faults are observed / not observed in analytical reports

 

    • Annexure- IX:  Conditional Batch Transfer Intimation Slip

Section A: Request Initiation 

From: Production                                                         To Quality Assurance

Date of Initiation:                                                          Initiated by (Sign/ Date):                                

The following product is required for conditional transfer

Product name: Batch no.:
Batch size: Market:
Mfg. Date: Expiry date:
FGTN No.: FGTN Date :
Reason:

 Request Approved by 

Head of Dept. (initiator Dept) (Sign/ date)                                              Plant Head (Sign/ Date):

Comments from QC

 

Sign/ Date (Head, Quality Control)

 

Section B: Approval of Conditional Transfer

 From: Quality Assurance                                         To Finished Goods Store

The above-mentioned batch is approved/ Not approved for conditional transfer.

Tentative date of release: 

Head -Quality Assurance

(Sign & Date)

    • Annexure-X:    Print Screen Batch Release ERP Module

      • Refer to the attached screenshot

    • Annexure-XI:   Print Screen Batch Release ERP Module (HOLD/ UNHOLD)

      • Refer to the attached screenshot

 

 

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Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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