Production
BRIEF DESCRIPTION OF PRODUCTION OPERATION USING, WHEREVER POSSIBLE FLOW SHEETS AND CHARTS SPECIFYING PARAMETERS.
The production planning department issues a computerized batch production record (BPR) for manufacturing a batch. The BPR consists of a Formulation order and a Packaging Order. The formulation order is as per the master formula, issued by QA Dept.and which has fed into the computer. Access to update this master formula on the computer is restricted only to concerned Q.A.Dept.
The Production Planning Department
Based on the bill of materials, the computer assigns. particular quantities of raw material(active & inactive) for that particular batch on FIFO basis. The dispensing of the material required for the particular batch against the particular Quality Control Analytical Reference No. mentioned in the Formulation order is done by a technician in presence of a warehouse supervisor.The batch is then fabricated/manufactured as per the manufacturing instructions given in the BMR.Every operation requires a doer and checker signature in process checks are carries out at predetermined time intervals by both, production and in process QA Executives and recorded in BMR. Samples of intermediates and finished goods are checked by Quality Control Laboratory. In case the batch meets the specifications, Quality Assurance reviews the complete batch manufacturing record to ensure compliance with cGMPs during the manufacturing. The batch is then released for distribution by the Q.A.
ARRANGEMENT FOR HANDLING OF STARTING MATERIAL, PACKING MATERIAL BULK AND FINISHED PRODUCTS, INCLUDING SAMPLING, QUARANTINE, RELEASE AND STORAGE.
All raw and packaging materials are received at the warehouse. On receipt of the material, the supplier‟s documents accompanying the goods are checked by warehouse officer. The warehouse personnel feed the details of these goods in the record book and under test label pasted on the material containers. The goods are stored in separate" under Test Area" Q.C.Executive draws a representative sample of the batch in the sampling booth. Sampling of raw materials, packing materials and intermediate are done as per the respective SOPs.
A pooled sample is tested by the Q.C.lab against approved specifications in case the material is approved, the data is fed in the computer as approval and the warehouse is informed. The Q.C.officer affixes "approved" sticker on each and every container and the material are moved to the "Approved Bay". In case of rejection the Q.C Dept." "Rejected "sticker on the containers and they are moved to "rejected Bay".
All material is stored in warehouse as per the storage conditions prescribed by the manufacturer. Dispensing of the material in warehouse is done in the dispensing area under a dispensing booth as per BPR issued by Production Planning Dept.and materials are transferred to Production Block. At intermediate stages during manufacturing IP Q.A draw random samples from each batch and send these for testing in Q.C.labs .Finished Goods after "Release" taken for distribution.
ARRANGEMENT FOR HANDLING OF REJECTED MATERIALS AND PRODUCTS.
Any raw or packaging material which does not confirm to the approved specification is treated as rejected material on completion of the testing of the Q.C.Dept.affixes "Rejected" Label on each such container and a Rejection Note is prepared by giving reasons for Rejection.
The stocks are moved to an area designated for rejected stock. The Purchase Dept. informs the vendor on the rejection along with the reasons for rejection. The rejected stocks are then sent back to the vendor. In case of rejection of labels, cartons the respective materials are destroyed in presence of the representatives from purchase warehouse, Q.C.Dept.and security controls. In case a batch does not confirm to specification then decision on destruction or reprocessing is taken by the Q.A, Manager in consultation.
BRIEF DESCRIPTION OF GENERAL POLICY FOR PROCESS VALIDATION.
As a policy of a company, all the processes are validated before the start of commercial production, any changes in a validated process have to be revalidated prior to switch over basis controlled through SOP.
A process is considered to be validated when three consecutive batches given results within the specified limits. Validation is carried out by a team consisting of managers from production and Q.A.