Terms and Conditions

Procedure for review, audit and storage of batch records and testing records

Byiamraj

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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  • Quality control samples withdrawn at appropriate stage and QC analysis results are with in limit and report of analysis attached with BPCR.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

SOP For Procedure For change control system

By iamraj