To lay down the Procedure for preparation of Preparation, Control, Issuance & Retrieval of Batch Record.
This Procedure is applicable to provide the guidelines for preparation of Preparation, Control, Issuance & Retrieval of Batch Record
Production and QA Personnel shall be responsible for follow the procedure mention in this SOP.
Production Manager and QA Head shall be accountable for compliance of this SOP.
Batch Record Issuance & Retrieval Record – Attachment-I
Batch Record Requisition Record – Attachment-II
Batch Record Format – Attachment-III
- PREPARATION OF BATCH RECORD:
- Batch Record shall be prepared as per Attachment-III.
- Batch Record shall be prepared by Production personnel, Checked by QA personnel & Head Production and Approved by Head Quality Assurance.
- Batch Record shall contain the following but not limited to.
- Dosage Name, Product Name, Label claim, Batch Size and other details.
- General Instruction, Line Clearance Instruction.
- Equipment Number.
- PREPARATION OF BATCH RECORD:
Bill of Materials, which should contain name of RM, specifications, AR No., and Quantity per batch, received and Verification details.
- Batch Record Manufacturing Instructions and In-process checks recording format (with acceptance limit) and sampling instructions.
- Batch Record shall contain stepwise manufacturing instructions with standard time limitation period and other parameters. E.g. Temperature, RH etc, space for recording the observation, space for initials of doer and verifier.
- Batch Record shall contain the labeling, Packing instructions (wherever applicable), Specimen Labels and printed packing material (where ever applicable for finished product), reconciliation record (of Packing Material & Yield) and description of deviation observed during batch processing.
- All critical parameters should be noted.
- BATCH RECORD NUMBERING SYSTEM:
- The Batch Record numbering shall be done as follows:
|BMR or BPR||/||YY||/||ZZZ||/||VV|
|Batch Manufacturing Record or Batch Packing Record.||Slash||Product Dosage i.e.
TB for tablets
CP for Capsule
DS for Dry syrup
OL for Oral Liquid
SC for sachets
|Slash||Sequential Number||Slash||Revision No. starting from 00|
- CONTROL AND ISSUANCE OF BATCH RECORD:
- As per Production planning the production personnel shall raise the Batch Record Requisition as per Attachment-II, mentioning the batch details.
- Batch Record request shall contain the product detail like B. No., Mfg Date, Expiry Date, Batch size etc.
- After receiving the product information, arrange for photo copy or pre-printed stock of Master copy of Batch Record.
- Photo copy or pre-printed stock of “Master Copy” of Batch Record shall be stamped as “Controlled Copy” with sign and date of QA authorized person on first and last page.
- Officer/ Executive QA shall verify the total number of pages in Batch Record to be issued and shall record the same in ‘Batch Record Issued By’ column on first page of Batch Record with “Total Pages verified= (indicating total pages in Batch Record)” and record the details in Attachment-I.
- Obtain signature from Production personnel/ Warehouse personnel as “Received by” in Attachment-I and Batch Record.
- After the completion of production activity and reconciliation of batch, the Batch Record shall be transferred to QA for review and enter in Attachment-I.
- In-case of cancellation of a batch due to unforeseen reasons, the issued copy shall be returned back to QA and the same shall be treated as ‘cancelled’ (Document in ‘Remarks’ column of the Batch Record Requisition Record Attachment-II.
- The cancelled copy shall be destroyed with the authorization of Head-QA and fresh copy shall be issued by request on Batch Record Requisition Record Attachment-I and retrieve copy shall be destroyed.
QC – Quality Control.
QA – Quality Assurance
Batch Record – Batch Manufacturing Record and Batch packing Record or Both
- DISTRIBUTION LIST:
10.0 HISTORY OF REVISION:
|Version No.||Effective Date||Reason for Revision|