Site shall be manufactured Tablets, Capsules, Liquid, Ointment and External Preparation for human use. Refer Annexure-II for list of products manufactured at site.
Multi general category products shall be manufactured at site in respective area.
In case the Finished Product does not conform to the specifications, the cause of failure is investigated. Remedial steps are taken to ensure that the cause does not recur. If the product does not conform to specifications for physical or chemical parameters, it is reprocessed as per the reprocessing procedure. Reprocessed batch will be identified with a unique Batch number.
Arrangements for the handling of starting materials, packaging materials, bulk and finished products including sampling, quarantine, release and storage;
There are separate storage areas for Raw & packaging materials and Finished Goods. Store receives the raw or packaging materials after reviewing the physical condition of the containers and ensuring the quantity as per the delivery challan and find everything satisfactory then the material is quarantined to the “UNDER TEST AREA”.
Goods Receipt Note (GRN) is prepared and sent to Quality Control department. On receipt of GRN; QC takes the entry of GRN in the Material entry register and arranges for sampling & analysis.
The store supervisor maintains the record for the receipt and issuance, bin cards and ‘GRN’s which ensures accountability and identity of the materials.
The QC draws the sample as per the sampling plan and analyzes as per the respective test procedure. If the material is released “Approved labels” shall be affixed on the containers of the material and the material shall be transferred to the “Approved material” area. If the material is rejected, “Rejected label” shall be affixed on containers of the material and the material shall be transferred to “Rejected material area” which is maintained under lock and key. The labels in the warehouse are color coded as per the status of the material viz. “Under Test, Approved or Rejected”.
Approved raw materials are issued to manufacturing department against the requisition of Material from manufacturing based on FEFO & and packing material based on the FIFO basis. Issuance and dispensing of the materials is carried out by the store chemist in the presence of QA officer/executive & Production supervisor.
Arrangements for the handling of rejected materials and products.
There are written procedures for the handling of Rejected Raw materials, Packing Material and Finished products.
In case any Raw or Packing Material does not comply with the Specifications, a rejection report is prepared and sent to the Stores for information. Quality Assurance Department controls the movement of rejected materials and maintains records in co-ordination with stores.
Stores in-charge ensures the transfer of material to “Rejected material area” under lock & key. In-charge-store sends the information to the Purchase department with all the details to take up the matter with the manufacturer/ supplier. An investigation report is asked from the manufacturer for the reason of failure and corrective & preventive actions are taken. If required re-qualification of the vendor is planned before any future supplies. Rejected material is either returned to the manufacturer or destroyed.
If finished product does not conform to specifications, QA investigates the failure as per the written down procedures. If required outcome of the investigation results is discussed with F&D and “Corrective & preventive actions” are planned for future.
In case it is possible to re process the batch, it will be done with proper authorization of “Head Quality Assurance”. Reprocessed batches will be kept on stability as per the “Stability Test Program”. If re-processing is not possible, the material will be destroyed with the authorization of Plant head and Manager Quality Assurance. Destruction records will be maintained with QA.
Arrangement for Handling of Rejected Materials:
All Rejected Materials shall be boldly labeled as ‘REJECTED’ in Red color label and stored in Rejected Material & Recall Goods Room until they are disposed off. Adequate care is taken to avoid mixing up with other materials.
Scrap & Waste Management:
Plant scrap & waste shall be handled as per respective SOP “Scrap Management” and HR department shall be responsible for the management of Scrap& waste. All the scarps& waste shall be collected from each department/office in polythene bag at the end of shift or as when required. This collected scrap/waste shall be sent to scrap yard for disposal. Collected scrap/waste shall be disposed off from factory premises by authorized outside scrap agency only. Representative from agency shall visit plant at regular interval and segregate the scrap/waste properly and kept at designated places in scrap yard. Security Personnel/Officer HR shall supervise scrap/waste while loading/disposed off from factory premises. Rejected printed packing material and empty tubes/bottles shall be destroyed by shredding machine in scrap yard prior removal from factory premises.
