1.0 PURPOSE :
To detail the procedure for issue, entry, review, release and control of Batch Records.
2.0 SCOPE :
Applicable while issue, entry, review, release and control of Batch Records.
3.0 RESPONSIBILITY :
Production, Stores, Quality Control and Quality Assurance.
4.0 PROCEDURE :
4.1 ISSUE OF BATCH RECORD ( BY QUALITY ASSURANCE)
4.1.1. Based on Production planning, production manager shall decide on the product and the number of batches to be produced in the month.
4.1.2. Production supervisor shall raise the requisition for the batches to be taken for the week and forward it to Quality Assurance.
4.1.3 On receipt of Batch Record issue requisition (Annexure -I) QA personnel will verify the details entered in the requisition form.
4.1.4 A photocopy of the MASTER COPY of the required Product Batch Manufacturing record and Batch Packing record will be taken.
4.1.5 All the pages of the photocopied sheet of Batch Record shall be signed and dated by QA Personnel.
4.1.6. Check for the correctness of the Batch number by verifying the Batch Record register.
4.1.7. Enter the details of Date, Product, Batch No, Batch size , Manufacturing Date, Expiry Date and issued by details in the Batch Record Register.
(Specimen of batch record register – Annexure II)
4.1.8 Check and allot expiry date by referring to master list of product shelf life.
4.1.9 If there is a deviation for change in batch size or any other equipment / process change raise deviation approval form as per deviation procedure SOP.
4.1.10 Enter the Batch No on all the pages of the of the Batch Record and get it authorised by QA Manager or in absence by QA Executive or QA Officer.
4.1.11 Insert the signed Batch record in a Batch Record cover ( Annexure III) and enter the details of product name , Batch Number, Batch size . Manufacturing date and Expiry date .
4.1.12 Batch record along with the Batch Record register shall be sent to production , the production person receiving the batch record should sign on the batch record register to acknowledge the receipt of batch record.
4.1.13 QA person who has issued Batch Record shall sign the “issued by” on batch record issue requisition sheet and file the same for future reference.
4.2. ENTRY OF BATCH RECORDS (By Production Personnel)
4.2.1. On receipt of batch record Production Manager / Dy. Production Manager shall check the batch record and sign on the first page.
4.2.2. The calculation sheet should be forwarded to stores for entry of the relevant AR Nos., quantity and assay value.