Procedure for review, audit and storage of batch records and testing records
- To lay down a procedure for review, audit and storage of batch records and testing records.
- This procedure is applicable to Quality Assurance, Quality Control and Production department of Formulation Plant of Pharmaceutical Company.
- QA officer / executive shall be responsible for batch review, audit and storage.
- Manager QA / Nominee shall be responsible for approval of the batch processing & control records.
- Head – QA shall be accountable for compliance of the SOP.
- On completion of batch processing operation, batch processing & control record shall be submitted to QA officer / executive by production department.
- QA executive shall check the batch record for compliance of all In-process check parameters with established / approved specifications before a batch is released for sale / dispatch.
- The personnel submitting the batch records with QA shall get acknowledgement of officer / executive QA in ‘Logbook for Batch Record Submission’ as per annexure.
- Batch processing records & control record shall be reviewed and audited for the following:
- Area / environmental monitoring record (for sterile products).
- BOM for quantity of raw material and Identification Lot No.
- Correct and released (by QC) raw materials / intermediates / packaging component used in manufacturing.
- Correct quantities of all ingredients are used in manufacturing.
- All dispensing tags of Raw Materials attached with BPCR.
- Equipment Identification number mentioned at appropriate place of operation.
- Rinse water / swab sample analysis reports attached with BPCR (if applicable).
- All significant steps of process are signed and dated by doer & checker.
- In-process checks performed at defined frequency and recorded at appropriate place in BPCR.
- Results of In-process checks are with in limit.
- Quality control samples withdrawn at appropriate stage and QC analysis results are with in limit and report of analysis attached with BPCR.
- Date and time of commencement and completion of different stages, in a logical sequential manner.
- Batch processing & control record is complete with respect to yield norms / reconciliation and is signed.
- Deviation (if any) recorded and approved.
- Signed specimen of all packing material used during packing are attached with BPCR.
- Finished product sample / control sample are with drawn and recorded in BPCR (as applicable).
- Finished goods transfer note is attached to the BPCR and verified by QA.
- Certificate of Analysis shall be reviewed and audited for the following:
- Name of Product
- Batch Number
- Batch size
- Date and Expiry date
- R. Number
- Specification details
- Compliance of finished product analysis results with specification.
- Raw Data sheet for QC testing shall be reviewed and audited for the following:
- Compliance with established specifications and standards.
- All graphs, charts and spectra from laboratory instruments attached.
- Proper unit of measure, conversion factors and equivalency factor used.
- Signatures of doer and checker along with date.
- The Batch Review Checklist shall be filled as per annexure.
- Manager QA shall go through the batch record, deviations (if any), COA, Batch Review Checklist reports and finally sign off the batch record(s), COA and Release note.
- The duplicate copy of the Release note, along with COA, Raw data sheet, Batch Review Checklist report(s), BPCR(s) shall be kept in a preprinted envelope, refer “SOP on Release of finished product”.
- Storage of batch processing records & QC analysis reports:
- After Manager QA has signed off the BPCR and Release Note of a batch, the QA officer / executive shall put the BPCR into a batch docket (envelop) along with Rinse water / swab test analysis report, dispensing labels and QC analysis reports.
- The checklist on the batch docket (envelop) shall be filled and signed off by the QA officer / executive for submission to documentation cell for storage.
- These batch records along with Q.C. analysis reports shall be retained (with QA) for a period of one (01) years from date of expiry of the product batch or 5 years from date of manufacturing of the batch, whichever is later.
- A Logbook shall be maintained for the batch dockets archived as per annexure.
- List of Annexure and Formats:
|S. No.||Format Title||Format Number||Annexure Number||No. of Pages|
|1||Logbook for Batch Record Submission||1|
|2||Checklist for batch record reviewing and auditing||1|
|3||Logbook for batch docket archival.||1|
- Reference (If any):
- SOP on SOPs
- Reason for Revision:
- Periodic revision
- Abbreviations & Definitions:
- COA – Certificate of Analysis
- BOM – Bill of material.
- BPCR – Batch processing and control record
END OF SOP
Logbook for Batch Record Submission
|S. No.||Product Name||Batch Number(s)||Blend / Individual Batch||Market||Submitted By||Received By||Date & Time||Remarks|
Checklist for batch record reviewing and auditing
|01||Raw Material dispensing sheet|
|02||Dispensing tag of raw materials attached to BPCR|
|03||Equipments cleaning status tags attached to BPCR (if applicable)|
|04||Equipment Identification No. mentioned at each step of operation.|
|05||Wash water / Swab analysis report attached to BPCR.|
|06||All specific processes were carried out with in specific time as mentioned in BPCR.|
|07||Date and time of all activities was recorded.|
|08||Date and time of commencement and completion of different operations.|
|09||Initials or sign of doer and checker of all steps along with date.|
|10||In-process checks parameters done at regular interval and recorded into BPCR.|
|11||Actual yields at appropriate stage.|
|12||Deviation and investigation (if any).|
|13||Control / Finished product analysis samples withdrawn|
|14||Final reconciliation of Batch|
|15||Finished product transfer note|
|16||COA of finished product for each market (if applicable)|
|17||COA of Active raw material|
Checked By / Date Approved By / Date
Logbook for Batch Docket Archival
|S. No.||Product Name||Batch No.||Batch Size||Market||Mfg. Date||Exp. Date||Submitted By / Date||Received By / Date||Remarks|