OBJECTIVE:

• To define the procedure for the controlled preparation, review, issuance, retrieval, revision and archival of Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) in compliance with Regulatory norm.
•  To ensure that all batch records are accurate, legible, contemporaneous and traceable in line with ALCOA+ data-integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available).

 SCOPE:

• Applicable to all BMR/BPRs prepared, reviewed, approved and issued for products manufactured or packed at Company.

RESPONSIBILITIES:

Designee Quality Assurance (QA):

• Shall issue controlled copies of approved Master Formula Records (MFRs).
• Shall maintain the master copies and revision history of all BMR/BPR templates.
• Shall ensure control of issuance, retrieval, review and archival.
• Shall maintain the issuance register and distribution records.
• Shall review the prepared BMR/BPR for correctness against MFR.
• Shall approve the document before use in manufacturing or packaging.
• Shall authorize the issuance of BMR/BPR to production.
• Shall verify compliance with the approved procedure.

Production Head

• Shall review draft BMR /BPR for completeness.
• Shall ensure that all manufacturing activities are executed strictly as per BMR/BPR.
• Shall verify and sign each completed stage and ensure in-process checks are performed.

DEFINATIONS:

• Master Formula Record (MFR): Authorized document describing raw materials, equipment, and detailed processing instructions for each product and batch size.
•  Batch Manufacturing Record (BMR): Executed record evidencing manufacture of one batch as per approved MFR.
• Batch Packaging Record (BPR): Executed record evidencing packaging activities.
• Obsolete Document: A superseded document withdrawn from circulation and stamped “OBSOLETE.”
• ALCOA+: Principles ensuring integrity of GMP data and records.
• Record Retention Period: Duration for which executed records must be archived—at least one year after product expiry or longer if required by regulatory authority or MAH.
•  Master Copy: The original, approved, and signed version of any controlled document (e.g., SOP, MFR, BMR, BPR, form, or record).

PROCEDURE:

• Preparation of BMR/BPR:
• Designee QA shall prepare BMR/BPR strictly as per the latest approved MFR template.
• Each BMR/BPR shall carry: Product Name, Generic Name, Batch No., Batch Size, MFR No., Mfg. /Exp Date, Shelf Life, Version No., Effective Date, and Product code No.
• All manufacturing and packaging steps shall be sequentially listed, starting from material dispensing to final reconciliation.
• Line-clearance and in-process-check sections shall be incorporated for each stage.
• Environmental parameters (temperature / humidity) and equipment identification shall be recorded.
• Each activity shall be signed and dated by “Doer” and “Checker.” Corrections shall be single-line struck, initialed, dated and justified—no overwriting

Review and Approval:

• Designee QA shall circulate the draft BMPR/BPR to production head for review.
•  If any query observed during the review of BMR/BPR, Production head shall inform it to Designee QA
•  Designee QA shall incorporate the queries raised by production head in the BMR/BPR.
• The updated version shall share with Head QA to verify completeness, accuracy, and compliance with MFR.
• Approved hard copy shall bear “MASTER COPY” stamp and signature on every page corner.

Issuance and Distribution:

• Trained and authorized QA personnel shall issue controlled copies against the request received from production.
• Each controlled copy shall be stamped “CONTROLLED COPY” in blue ink at page bottom.
• Issuance details (Batch No., Mfg. Date, Exp. Date and, issued by/Received by) shall be logged in the BMR/BPR Issuance Register.

Execution:

• Manufacturing and packaging shall be performed strictly per BMR/BPR instructions.
• Yields and reconciliation at each critical stage shall be recorded and verified by QA.
• All deviations, incidents or OOS events shall be cross-referenced with respective investigation numbers.
• BMR/BPR shall reviewed by production manager followed by designee QA.

Retrieval and Archival:

• On batch completion and QA release, reviewed BMR/BPR shall be returned to QA.
• BMR/BPR retention shall be minimum one year after expiry.
• Master Copy: Product related documents shall be kept for 5 years in hard copy and forever in soft copy.
• Obsolete BMR/BPR records shall be shredded in presence of Designee QA and it shall record in the log (F/QA022/004 – 00).

Revision / Change Control:

• Any modification in process, equipment or document content shall follow initiated through Change Control.
• Revised BMR/BPR shall receive a new version number; change history shall be recorded.
• Obsolete copies shall be stamped “OBSOLETE” on each page and destroyed by shredding under QA supervision.

Training:

• All concerned personnel shall be trained on this SOP before implementation.
• All concerned personnel shall be trained on revised BMR/BPR.

REFERENCE:

• EU GMP Part I, Chapter 4 – Documentation
• EU GMP Annex 11 – Computerized Systems
• WHO TRS 986 Annex 2 (Documentation)

RECORDS:

 REVISION HISTORY: