To lay down the procedure for Batch Manufacturing Operations in Production Blocks.
1.0 PURPOSE
To lay down the procedure for Batch Manufacturing Operations in Production Blocks.
2.0 SCOPE
2.1 This procedure is applicable to all Production Blocks, Warehouse and QC for Batch Manufacturing Operations.
3.0 RESPONSIBILITY
3.1 Personnel - Production Blocks
3.2 Personnel – Warehouse
3.3 Personnel - QC
3.4 Personnel - QA
4.0 ACCOUNTABILITY
4.1 Head – Production.
4.2 Head – QC
4.3 Head – Warehouse
4.4 Head – Quality Assurance
5.0 PROCEDURE
5.1 Production Planning :
5.1.1 Production Manager shall plan the production activities on campaign basis as per the requirements.
5.1.2 Production Planning shall include the availability of the following, as basic requirements :
5.1.2.1 Personnel
5.1.2.2 Equipment
5.1.2.3 Utilities
5.1.2.4 Raw material, solvents and packaging material
5.1.2.5 Documents such as MPCR and BPCR etc.,
5.1.3 Before planning to start a batch, ensure the availability of all the requirements mentioned in the 5.1.2.
5.2 Indenting of raw materials, receipt and storage of dispensed raw material:
5.2.1 Production department shall request for Batch Production and Control Record (BPCR) to Quality Assurance (QA) Department and QA shall issue the batch numbered BPCR as per Standard Operating Procedure Issue, movement and storage of Batch Production and Control Records.
5.2.2 Production Executive shall indent the raw materials for the batch as per the Raw Material Issuance Record, in the format attached with the BPCR.
5.2.3 Warehouse shall dispense the material as per the Raw Material Issuance Record. Production Executive shall ensure the correctness of the weights of the dispensed material in the staging area as per the raw material issuance record and sign on the material issue tags.
5.2.4 All the dispensed materials shall be received in the production block in closed containers.
5.2.5 Dispensed materials shall be handled and stored in labeled closed containers in the designated place of production block to prevent contamination, and cross-contamination.
5.2.5.1 If the batch is not charged in the month in which the BPCR is issued, the BPCR shall be returned to QA alongwith the reasons for destruction and new BPCR shall be taken from QA. The raw material issued for the old batch shall be used for the new batch. This will be handled by raising a deviation by production department.
5.2.6 Dispensed material shall be stored batch wise off the floor on pallets and suitably spaced to permit cleaning and inspection.
5.3 Startup of a batch :
5.3.1 Before starting up of a batch, ensure that due dates for calibration and preventive maintenance are not over-due for all the equipment to be used as mentioned in the BPCR.
5.3.2 Ensure that the area around the equipment is clean.
5.3.3 Ensure the cleaning status of the equipment in the equipment log and update the status label.
5.3.4 Before charging the raw materials, ensure the weight and batch number on the material issue tag to which it is dispensed.
5.3.5 Ensure that only one powder material is being charged at a time in production floor to prevent cross contamination.
5.4 Batch Processing :
5.4.1 Batch Processing operations shall be carried out as per the instructions mentioned in the Batch Production and Control Record (BPCR) and as per the respective Standard Operating Procedures.
5.4.2 At the completion of each manufacturing step, the BPCR must be filled and signed in the appropriate space by the person performing the job immediately after it is done.
5.4.3 Charging of materials / Unloading of material into / from the equipment, shall be done according to the procedures mentioned in the Standard Operating procedures of respective equipment.
5.4.4 Ensure that additional protective apparel, such as head, face, hand, and arm coverings, are worn, when necessary, to protect the material from contamination during charging and unloading.
5.4.5 Personnel should avoid direct contact with material to avoid contamination.
5.4.6 Production chemist shall perform in-process sampling as per the procedures mentioned in the MPCR, BPCR and respective Standard Operating Procedures.
5.4.7 In-process samples shall be labeled for identification of product name, batch number etc., and sent to the In-process Quality Control lab for testing along with Technical Information Request, which is given as Annexure – II.
5.4.8 Batch shall be further processed only after complying with in-process specifications mentioned in the BPCR.
5.4.9 Any deviation occurs in the batch processing shall be handled as per the Standard Operating Procedure Handling of Deviation.
5.4.10 All packing and labeling operations of Intermediates / API’s shall be done according to the procedures mentioned in the MPCR and BPCR.
5.4.11 Containers / pipes used for storing waste material shall be identified and waste material shall be disposed off in a safe and sanitary manner by following respective Standard Operating Procedures.
5.4.12 After completion of any operation in equipment, Equipment Usage Log shall be filled and signed in the appropriate space by the person performing the job.
5.4.13 Equipment and utensils shall be cleaned, stored as per the respective Standard Operating Procedures to prevent cross contamination after its use.
5.5 Forwarding the executed BPCR & Sampling request:
5.5.1 After completion of all processing operations as mentioned in the BPCR, Head-Production or his deputy shall review the BPCR for the compliance of the following as basic requirements.
5.5.1.1 All steps are performed as directed and signed.
5.5.1.2 All material issue tags are attached to the BPCR.
5.5.1.3 All production deviations during batch processing are reported and handled as per Standard Operating Procedure Handling of Deviation.
5.5.1.4 All the in-process parameters are complied as per the specification and all Technical Information Requests are attached to the BPCR.
5.5.2 After review of the BPCR by Head – Production or his deputy, BPCR shall be sent to Quality assurance department along with Sampling Request Slip in duplicate as given in xxxxxx Annexure–I and Product Transfer Slip (xxxxx Annexure – II of Standard Operating Procedure xxxxx) in triplicate.
5.6 Release of the batch:
5.6.1 After completion of the analysis of the batch, QA will release the batch as per Standard Operating Procedure Batch Release.
5.6.2 After release of the batch, QA will send Product Release and Transfer Slip to production department for transfer of material to Warehouse.
5.7 Transfer of material to Warehouse:
5.7.1 All isolated intermediates and API’s shall be handled and stored to prevent degradation, contamination and cross contamination as per the conditions given in MPCR and BPCR till the release of the material.
5.7.2 All isolated intermediates and APIs shall be stored off the floor on pallet and suitably spaced to permit cleaning and inspection.
5.7.3 After release of the batch by Quality Assurance department, production department shall transfer the material to warehouse with production release and transfer note in closed containers with proper identification [as per the instructions given in BPCR and MPCR].
5.8 Handling of rejected material:
5.8.1 Rejected intermediates and API’s shall be identified and shall be placed at designated area designed to prevent their unauthorized use in the plant till further approval for the reprocess or rework.
5.8.2 Reprocessing of intermediates / APIs shall be done as per the approved procedure and follow Standard Operating Procedure Reprocessing of intermediate / API
5.8.3 Reworking of intermediates / APIs shall be done as per the approved procedure and follow Standard Operating Procedure Rework of intermediate / API
END OF DOCUMENT
Batch manufacturing, operations, quality assurance
