To lay down the procedure for preparation of Batch Production and Control Record (BPCR) and Master Production and Control Record (MPCR).
1.0 PURPOSE
To lay down the procedure for preparation of Batch Production and Control Record (BPCR) and Master Production and Control Record (MPCR).
2.0 SCOPE
2.1 This procedure is applicable in Production and Quality Assurance.
3.0 RESPONSIBILITY
3.1 Head - Production
4.0 ACCOUNTABILITY
4.1 Manager - Quality Assurance
5.0 PROCEDURE
5.1 Preparation of MPCR
5.1.1 MPCR shall be prepared on the basis of R&D technical document.
5.1.2 MPCR shall contain the following but not limited to
5.1.2.1 Product name & Batch Size.
5.1.2.2 Facility name and list of major equipment
5.1.2.3 List of RM designated by name and code.
5.1.2.4 Quantity of RM with unit of measure.
5.1.2.5 Detail manufacturing instructions in sequential order with process parameter and inprocess control with acceptance limit.
5.1.2.6 Sampling, Labelling & Packing instruction.
5.1.2.7 Expected yield at every stage.
5.1.2.8 Special precaution to be followed if any.
5.1.3 Storage condition of intermediate & Active Pharmaceutical Ingredients (API).
5.1.4 MPCR shall be prepared on the format given in Annexure – I.
5.1.5 MPCR shall be prepared, checked and approved by a group consisting of personnel from production, R & D (if required), and Quality Assurance.
5.1.6 MPCR shall be approved by Head QA.
5.2 Preparation of BPCR
5.2.1 BPCR shall be prepared on the basis of MPCR.
5.2.2 BPCR shall contain the following but not limited to
5.2.2.1 BPCR No.
5.2.2.2 Batch Size.
5.2.2.3 Batch release statement with Mfg.Date, Exp. Date, Output and Manager QA signature.
5.2.2.4 Batch review checklist.
5.2.2.5 Instruction, Control and safety precaution.
5.2.2.6 Equipment Number and SOP reference.
5.2.2.7 Material Indent Instruction.
5.2.2.8 Batch formula which should contain name of RM, RM code, Unit of Measurement, Quantity per batch, Place for recording the Analytical Ref.No and Quantity Verification signature.
5.2.2.9 Batch Manufacturing Instruction and recording format.
5.2.2.10 Recording format should contain stepwise manufacturing instruction with standard time limitation period and other parameters. e.g. Temperature, Pressure etc, Place for recording the observation, place for initials of performer and verifier.
5.2.2.11 BPCR should contain the inprocess parameters, acceptance limit and sampling instructions.
5.2.2.12 BPCR shall contain the labelling, Packing instruction (wherever applicable), Specimen Labels and printed packing material (where ever applicable for finished product), reconciliation record and description of deviation observed during batch processing.
5.2.2.13 All critical parameter should be highlighted.
5.2.2.14 BPCR shall be prepared in the format given in Annexure – II.
5.2.3 BPCR shall be prepared, checked and approved by a group consisting of personnel from production, R & D (if required), and Quality Assurance.
5.3 MPCR/BPCR Numbering System.
Batch production, control record, quality assurance
