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

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  • Quality control samples withdrawn at appropriate stage and QC analysis results are with in limit and report of analysis attached with BPCR.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 TitleFormat NumberAnnexure NumberNo. of Pages
1Logbook for Batch Record Submission1
2Checklist for batch record reviewing and auditing1
3Logbook 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 NameBatch Number(s)Blend / Individual BatchMarketSubmitted ByReceived ByDate & TimeRemarks

Checklist for batch record reviewing and auditing 

S.No.ChecksObservation

Yes/No/NA

01Raw Material dispensing sheet
02Dispensing tag of raw materials attached to BPCR
03Equipments cleaning status tags attached to BPCR (if applicable)
04Equipment Identification No. mentioned at each step of operation.
05Wash water / Swab analysis report attached to BPCR.
06All specific processes were carried out with in specific time as mentioned in BPCR.
07Date and time of all activities was recorded.
08Date and time of commencement and completion of different operations.
09Initials or sign of doer and checker of all steps along with date.
10In-process checks parameters done at regular interval and recorded into BPCR.
11Actual yields at appropriate stage.
12Deviation and investigation (if any).
13Control / Finished product analysis samples withdrawn
14Final reconciliation of Batch
15Finished product transfer note
16COA of finished product for each market (if applicable)
17COA of  Active raw material

Checked By / Date                                                                                        Approved By / Date

 

Logbook for Batch Docket Archival

S. No.Product NameBatch No.Batch SizeMarketMfg. DateExp. DateSubmitted By / Date Received By / DateRemarks

SOP For Procedure For change control system

About ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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