BRIEF DESCRIPTION OF PRODUCTION OPERATIONS :
Well defined production operations are adopted for manufacture of Pellets, Capsules and Tablets. Before any processing operation is started, steps are taken to ensure that the work area and equipment are clean and free from earlier batch materials i.e. line clearance will be certified by the IPQC Chemist. Double Checks are exercised while handling materials into batch. Materials are analysed at various stages in the process to identify any deviation in procedure or in stability of the product. Content uniformity is observed before compression by drawing samples from the mix and also all finished products are analysed before packing as per the current G.M.P.
HANDLING OF MATERIALS :
All raw materials on receipt will be unloaded in “Quarantine Area”, sampled labels will be put by Q.C. department. After analysis, QCD will fix approved/ rejected labels on all the containers of the consignment as the case may be. Rejected raw materials will be shifted to the “Area for Rejected raw materials”, while the Approved materials will be shifted to the area designated “Area for Approved materials”. All the raw materials will have in-house Q.C. numbers and will be recorded wherever required.
HANDLING OF REJECTED RAW MATERIALS AND PRODUCTS:
Rejected raw materials will be shifted to the area designated for rejected raw materials. From there, they will be lifted by the supplier. In-process materials will be re-processed and cause of defect will be thoroughly investigated. In case of finished products, they will be destroyed after investigation.
GENERAL POLICY FOR PROCESS VALIDATION:
New processes are developed by the Q.A.D. team and number of experiments like stability studies etc., are carried out ot identify effect of different excipients on the stability of the finished product.
The process validation is carried out to verify and to assure that a process can reliably perform its intended function in an acceptable manner.
SELF INSPECTION SYSTEM:
- We have check list system at.
- Raw material issues.
- Packing material issues.
- Process control in the batch sheet.
- Entry system in the specified areas.
All the raw materials are identified with code nos and in-house A.R.Nos. which can be cross checked with Q.C., Stores of Batch sheets. Similarly, Packing materials can be traced through batch sheets.