SOP for Batch Release
This Document describes (Standard Operating procedure) SOP for Batch Release and Rejection.
SOP for Batch Release and Rejection.
I. Purpose & Scope:
- The purpose of this SOP for Batch Release and Rejection.
- This Standard operating procedure shall be applicable for Batch Release and Rejection.
II. Responsibilities:
• All Quality Assurance personnel shall be responsible to follow and implement this SOP.
III : Introduction and Procedural Part:
Precaution:
- Good Manufacturing Practices (GMP) and Good Documentation Practice (GDP) to be strictly adhered during manufacturing, recording and reviewing of batch records.
- Dispensing labels must be attached to BMR/BPR
- Any Deviation, OOS, Failure Investigation, Change Control if any should be reviewed before batch release to packaging and same to be closed before its dispatch to commercial distribution.
- All duly approved specimens of overprinted packing material like Label, Carton, Leaflet, Aluminum foil, and Shipper label must be attached to BPR.
- Material Return Note (MRN) and Extra Material Request Note (EMRN), if any must to be attached to BMR/BPR.
Release of Intermediate stage of manufacturing:
- On completion of intermediate stage of manufacturing, production department shall send the duly filled and sequentially arranged Batch Manufacturing Record (BMR) along with ‘Test request form’ (TRF) to QA department for sampling.
- QA personnel shall carry out the sampling as per respective SOP “In-process Sampling of Drug Products at Various Stages of Manufacturing Process” and shall submit the sample to QC department for analysis.
- QA executive/designee shall review the completed intermediate stage BMR and review of analytical test report of QC for its compliance after analysis of respective intermediate stage.
- If found satisfactory, QA executive or above shall release the intermediate product with affixing “APPROVED” label on container.
- IPQA officer shall record any deviation/deficiency (if any) in the Annexure-III and return the BMR to Production Officer for their rectification. In case of critical discrepancy, IPQA executive/designee shall inform immediately to Head-QA and file the deviation for corrective action, and affix “QA HOLD” label on outer container. Upon rectification/corrective action; QA Executive/designee shall release the intermediate stage of manufacturing.
- After sampling of intermediate, further process can be carried out. However, batch shall not be released until complete testing of bulk stage is completed to release bulk for packaging.
Review of Batch Manufacturing and release of Bulk Product for Packaging:
- After complete reconciliation of BMR; production officer shall hand over the reconciled Batch Manufacturing Record (BMR) to Production Head for review.
- After review, Production Head shall submit Batch record to In-process Quality Assurance (IPQA) for any deficiency along with ‘Test request form (TRF)’ in duplicate for sampling.
- Test Request Slip (TRF) shall raise in Duplicate as per respective BMR upon completion of Bulk manufacturing stage (i.e. in case of Un-coated tablet at Compression stage and Coated Tablet at Coating stage and in case of Capsule at filling stage) for bulk sampling of the respective product. However, in case of Injection TRF shall be initiated as per their respective BMR/BPR or as per respective Protocols.
- QA personnel shall carry out the sampling as per SOP and shall submit the sample to QC department for analysis.
- IPQA officer shall review the record as per as per BMR with respective to completeness review Check list, Annexure-IV for the detail but not limited to complete entries, stage wise yield reconciliation, destruction record, any Deviation, Change Control, Failure Investigation Corrective Action and Preventive Action (CAPA), Out Of Specification (OOS) and missing of any entries/signature etc.
- After QC analysis, QA Reviewer shall check the QC reports for its compliance.
- If found satisfactory, QA executive or above shall release the intermediate product with affixing “APPROVED” label on container.
- IPQA officer shall record any deviation/deficiency (if any) in the Annexure-III and return the BMR to Production Officer for their rectification. In case of critical discrepancy, IPQA executive/designee shall inform immediately to Head-QA and file the deviation for corrective action, and affix “QA HOLD” label on outer container. Upon rectification/corrective action; QA Executive/designee shall release the bulk-finished product for packing activity.
- After sampling bulk can be packed. However, batch shall not be released until complete testing is completed and COA is available with QA prior to release.
Review of Batch Packaging Record and transfer to BSR :
- After completion of batch, BPR shall be reviewed by Production Head.
- On completion of packing of the batch or a particular pack size, Packaging department shall raise the finished product test request along with reviewed BPR to Quality Assurance Department along with ‘Test request form (TRF)’ in duplicate for sampling.
- QA personnel shall carry out the sampling as per SOP and shall submit the sample to QC department for analysis.
- IPQA officer shall ensure the completion of BPR with respect to completeness of entries, final batch yield reconciliation, any Deviation, Change Control, Failure Investigation, their CAPA and missing of any signature. IPQA officer shall record any deviation / deficiency (if any) in the Annexure-III and return the BPR to Production Officer for their rectification.
- After QC analysis, QA Reviewer shall check the QC reports for its compliance.
- If found satisfactory, QA executive or above shall release the intermediate product with affixing “APPROVED” label on container.
- In case of critical discrepancy, IPQA executive/designee shall inform immediately to Head-QA and file the deviation for corrective action, and affix “QA HOLD” label on outer container. Upon rectification/corrective action; batch is ready for batch release authorization and subsequent release for commercial distribution.
- In case of part batch release; a separate BPR shall be reviewed as per split batch packing record from mother batch as well as Mother BMR, Final Reconcile of the batch yield shall be done at the last batch packing.
- The Goods shall be transferred to BSR after effective evaluation of Batch Packing Record.
- Applicable product of Bar code label, one copy of bar code label shall be affixed with BPR.
Procedure For Partial batch /complete batch release :
- Part Dispatch shall be given in case of Batch Split / Conversion from Mother Batch at packing stage and same shall be authorized by Plant Head and Head QA.
- Before certifying a batch prior to Part release / complete batch for dispatch Head QA / designee of batch release shall conform the following requirements are met:
- Batch Records (BMR & BPR) shall be reviewed.
- Batch documents are complete in all respects and duly signed by the responsible officer up to the stage of transfer.
- All the in-process checks are carried out by production and QA according to Batch packing record and relevant SOPs.
- Any deviations / nonconformity / OOS / Change controls are addressed and corrective actions taken if applicable.
- Reserve samples / control samples, and other samples as applicable, are collected and the quantity mentioned in the finished goods transfer note.
- QA officer shall verify the Finished Product Certificate of Analysis along with availability of COA and complete analysis record of finished product.
- Batch Release Note shall be recorded by QA Officer in “Batch Release Log” (Refer Annexure – II)
- Batch release authorization is done by Head QA who acts as a qualified person as well as Responsible Person and has knowledge of Quality Management System relevant to the product and it is required to certify.
- Head-QA or designee shall ensure the above compliance. After satisfactory evaluation Head-QA, or designee shall release the finished goods for distribution by signing the Batch Release Note with date.
- Batch Release for Dispatch shall be intimated to warehouse by QA through Approved copy of
- “Batch Release Note” in the Annexure–I, for other than EU/US products.
- “Batch Certificate for Medicinal Products for EU/US” for manufactured batches for EU/US.
- Batch release note shall be prepared in duplicate copy. From these, original batch release copy shall be given to warehouse department and duplicate copy of the same shall be attached to respective Batch Records.
- Product Release Note shall be issued for each batch as per below numbering system.
For Example: PRN/Batch Number
Where, RN = Product Release Note
- For example – RN/ XY9001 for first batch manufactured for tablet dosage form in year 2019.
- After preparation of dispatch document, Warehouse shall inform QA for final check, before loading it into the transport vehicle.
- Palletization (if applicable) shall be done in standard configuration as per requirement
- Warehouse (Dispatch Department) officer shall dispatch only after getting Batch Release Note and Certificate of Analysis (COA) Approved by Head – QA / Designee.
- After release, Head-QA or designee shall send the compiled batch documents to Documentation Assurance for retention.
BMR/BPR review point
Critical Point:
- Line or area clearance for any manufacturing process is incomplete.
- Checking of the weights for the active ingredient and its addition is verified the record for checking of weight of Active Ingredients & its addition.
- Dispensed material not verified for weight and other details.
- Any process deviations carried out without formal approval of authorized personnel.
- Inability or discrepancies to carry out packing material reconciliation with exception to material such as foil rolls, PVC roll, BOPP Tape etc.
- Missing entries such as humidity, temperature, pH, QC reports etc.
- Missing signatures of supervisors for critical activities such as dispensing, blending, mixing, drying, lubrication, compression, coating, filling, and packing.
- No explanations for the addition/deletion of extra/required ingredients.
- Addition of drug substances without checking the quantity to be added based on the potency.
- Missing to attach specimen of labels, foils, cartons, overprinted material etc. duly signed by production and QA taken at the time of each processing step of the manufacturing or packing process.
Minor Point :
- One of the signature missing.
- Date Missing in a sequential flow.
- Over writing in entries and Error due to transcription of entries.
- Leaving blank spaces instead of striking out the area or writing NA.
- Verification sign of any of the ingredient is missing from BMR.
- Missing ancillary documents that are found later
- Omission of date of start and end of processing.
- Control sample entry missing in the BMR/BPR.
Approved Batch Release Person :
- In house Approved batch release person list shall be maintained.
- Approved batch release person list shall be updated annually or any change in the approved batch release person.
IV : ANNEXURE:
| Annexure No. | Format Name |
| Annexure-I | Batch Release Note |
| Annexure-II | Batch Release Log |
| Annexure-III | BMR/BPR Review sheet |
| Annexure-IV | BMR Review Checklist |
| Annexure-V | BPR review Check List |
Annexure I
BATCH RELEASE NOTE
Reference TT No.:- Product Release Note No. : RN/………………….
| Product (Brand Name) | |||
| Generic Name | |||
| Batch No. | Batch Size | ||
| Mfg. Date | Exp. Date | ||
| FPCOA A.R. No. | Released On | ||
| Total Release Qty. | Pack Style | ||
| Description of Release Quantity | : | |
| Full Shipper…………………………………………………………..
Loose Shipper……………………………………………………….
Control Sample………………………………………………………
Stability sample………………………………………………………
Other sample…………………………………………………………
Total quantity transferred for Dispatch………………………………
|
||
| Market | : |
Domestic/Export……………………………………………………..
|
| If Export, Country Name: ……………………………………………
|
||
| Remark (If any) | : | ………………………………………………………………………
|
I certify that the above product has been manufactured, tested and packaged according to the principle and guidelines of current Good Manufacturing Practices as laid down and that requirement of both the product Marketing Authorization and the manufacturing license has been met.
| Prepared By (QA) | Checked & Released By Head – QA |
|
|
|
| Signature / Date | Signature / Date |
Annexure II
Batch Release LOG
| Sr. No. | Batch No. | Brand Name /
Generic Name of Product |
PRN No. | Mfg. Date & Exp. Date | Released Qty.
(Nos.) |
Domestic / Export (If Export Country Name) | Batch
Released On |
Done By
(Sign & Date) |
Remarks |
Annexure III
BMR/BPR review sheet
Product Name: _________________________________________________________________________
Batch No.: _____________________________ Batch Size: ________________________________
| Page No. | Observations / Deficiencies | Compliance Status | Done By Prod. (Sign.) |
Batch Reviewed by: Compliance Verified By:
(IPQA Officer / Executive) (IPQA Officer / Executive)
Sign. / Date: Sign. / Date:
Annexure IV
BMR Review Checklist
| Sr. No. | Check points | Status |
| 1 | Is certified copy of BMR used. | Yes / No |
| 2 | Batch Number available in all pages. | Yes / No |
| 3 | Manufacturing and Expiry is correctly quoted. | Yes / No |
| 4 | Dispensing carried out on calibrated balance. | Yes / No |
| 5 | Line clearance is taken prior to all dispensing and manufacturing activities. | Yes / No |
| 6 | Dispensing is carried out as per Bill of Materials. | Yes / No |
| 7 | All the dispensed labels are properly attached. | Yes / No |
| 9 | Environmental condition complies during all the manufacturing stage. | Yes / No |
| 11 | No over writing are observed. All wrong entries are have been strike out and signed. | Yes / No |
| 13 | Actual equipments used are as specified. | Yes / No |
| 14 | Sieve integrity has been checked before and after sifting. | Yes / No |
| 15 | Dry mixing done as per specified time. | Yes / No |
| 16 | If additional raw materials issue, documents are attached. | Yes / No/ NA |
| 17 | Reconciliation details of all intermediate stage. | Yes / No |
| 18 | Compression and coating activity are carried out after IPQA approval. | Yes / No |
| 19 | All the in-process check results comply within the acceptance limit. | Yes / No |
| 20 | All the blank spaces are filled correctly and there are no pending entries. | Yes / No |
| 21 | If there is any deviation during the process, it is recorded in Batch manufacturing sheet and Deviation is raised and approved. | Yes / No/ NA |
| 22 | Batch Reconciliation is completed. | Yes / No |
| 23 | Phase wise yield reconciliation done. | Yes / No |
| 24 | If yield is outside the limit is investigated and justified. | Yes / No / NA |
| 25 | QC approval is available on Test Request Form. | Yes / No |
| 26 | Analytical work records received. | Yes / No |
| 27 | Analytical results found within the acceptance criteria. | Yes / No |
| 28 | All entry in Request for Issue of BMR found complete. | Yes / No |
| 29 | All pages properly assembled and found OK. | Yes / No |
Reviewed By
(Sign. Date):
Annexure IV
BPR Review Checklist
| Sr. No. | Check points | Status |
| 1 | BPR is completed | Yes / No |
| 2 | Is certified copy of BPR used | Yes / No |
| 3 | All the pages are available. | Yes / No |
| 4 | Batch Numbers available in all pages. | Yes / No |
| 5 | Manufacturing and Expiry is correctly quoted. | Yes / No |
| 6 | Dispensing carried out on calibrated balance. | Yes / No |
| 7 | Line clearance is taken prior to all dispensing and packing activities. | Yes / No |
| 9 | Dispensing is carried out as per indents of Primary and Secondary packing materials | Yes / No |
| 11 | Environmental condition complied during all the packing steps. | Yes / No |
| 13 | No overwriting observed. All wrong entries scored out and signed. | Yes / No |
| 14 | All overprinted specimens are attached with signature | Yes / No |
| 15 | Leaflets from all individual packs are collected and attached with signature | Yes / No |
| 16 | Destruction record of printed packing material is filled and destruction is verified by IPQA. | Yes / No |
| 17 | Surplus packing materials return note is filled and surplus quantity of packing material is returned. | Yes / No |
| 18 | If there is any interruption during the process, it is recorded in Process Interruption sheet and signed by IPQA. | Yes / No/ NA |
| 19 | Batch Reconciliation is completed and complies within the limit. (In case it is outside limit justification is available). | Yes / No |
| 20 | Packing material reconciliation is filled and variance is within acceptance limit. | Yes / No |
| 21 | TRF with QC approval, copy of Results Of Analysis and COA is available. | Yes / No |
| 22 | Batch Release Form is available. | Yes / No |
| 23 | Analytical results found within the acceptance criteria. | Yes / No |
| 24 | In shipper weighing record none of the shippers are out of limit. Where any shipper weight is out of limit, has seen opened and quantity verified | Yes / No |
| 25 | All entry in Request for Issue of BPR found complete. | Yes / No |
| 26 | Any deviations / incidents are documented, investigated and disposed. | Yes / No/ NA |
| 27 | If Yield is outside the limit, if investigated and justified | Yes / No/ NA |
| 28 | All pages properly assembled and found OK. | Yes / No |
Reviewed By
(Sign. Date):
