Production

Capacity

The batch is manufactured and packed as per the manufacturing instruction given the BMR and MFR respectively. Every operation requires a 'doer' and 'checker' signature. All in-process checks are carried out at pre-determined time intervals by both Production and IPQA Officers in the In-process Quality Control labored, and record. in the BMR. Samples of in-process stage(s) and finished Product are analyzed by Quality Control Laboratory, as Per SIPS. After the completion of the batch, Production Executive/Officer reconciles the packing materials and the yields. Production Manager followed by the IPQA Officer checks the reconciliation. IPQA officer withdraws the control samples and the packed batch is then transferred to the Finished Products Store. In case the batch meets the specifications, BMRs and the batch testing, records are reviewed by the Quality Assurance Manager/Manager-QC/General manager Production, to ensure compliance with cGMP during the manufacturing and packing. When found to be complying, the Batch is released for distribution / sale by the Quality Assurance Manager or his authorized representative. Brief description of production operations using, wherever possible flow sheets and charts specifying important parameters as Appendix XVII for Tablets, Appendix XVIII for Capsules and Appendix XIX for Oral Liquid.


Infrastructure