Procedure for review, audit and storage of batch records and testing records
- Objective:
- To lay down a procedure for review, audit and storage of batch records and testing records.
- Scope:
- This procedure is applicable to Quality Assurance, Quality Control and Production department of Formulation Plant of Pharmaceutical Company.
- Responsibility:
- 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.
- Accountability:
- Head – QA shall be accountable for compliance of the SOP.
- Procedure:
- 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- Quality control samples withdrawn at appropriate stage and QC analysis results are with in limit and report of analysis attached with BPCR.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
| S.No. | Checks | Observation Yes/No/NA |
| 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 |