GuidelinePharma

Movement of dispensed materials OBJECTIVE To lay down a procedure of movement of dispensed raw and packing material to the production area. SCOPE This SOP is applicable for transferring dispensed raw materials and packing materials to the production area. RESPONSIBILITY Stores Officer, QA Officer, Production Supervisor, and Packing Supervisor shall be responsible to follow the…

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Inspection of incoming foil OBJECTIVE: To lay down a procedure for the incoming inspection of foil rolls. PROCEDURE:  After the security staff checks and allows the vehicle to enter the plant area, check the documents for foil rolls received – purchase orders/ invoices. Check the vendor as per the vendor list. If the material comes…

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Dispensing of additional materials OBJECTIVE : To lay down a procedure for dispensing additional material. PROCEDURE  Production personnel must send a filled Additional Material Requirement Note (AMRN) for the necessary additional materials. The following details have to be entered in the AMRN. Date Product name Batch number Material name Material code, Document number Unit of measurement…

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Dispensing of packing material OBJECTIVE: To lay down a procedure for dispensing packing material. PROCEDURE  Get the order for a certain packing material at least one day in advance. The FIFO method has to be used while dispensing packing material. The packing material should be taken by the workers of the store only after checking the…

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Dispatch of finished goods OBJECTIVE: To lay down the procedure for dispatching finished goods from the warehouse. ATTACHMENTS :Register of Finished product  PROCEDURE  When you ensure that the batch is approved by QA and released by Authorized Person, start dispatching as per the order, received from the shipping department. Prepare the required quantity of corrugated…

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Cleaning Of Sampling Booth OBJECTIVE  To lay down a cleaning procedure for the Sampling booth. PROCEDURE  DIFFERENT MATERIAL CHANGE OVER Remove all the containers and the materials of the product. Remove the area and the equipment status label. Transfer all the sampling aids to the QC department washing area. Remove the pre-filters and clean the…

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Сleaning of dispensing booth OBJECTIVE  To lay down a cleaning procedure of dispensing booth. PROCEDURE  PRODUCT-TO-PRODUCT CHANGE OVER Check and ensure that there are no dispensed materials in the dispensing booth. Clean the balances with a clean dry cloth. Remove scoops, spoons, bowls, and liquid pumps from the dispensing booth to the washing area of…

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Сleaning and handling of dispensing tools OBJECTIVE  To lay down a cleaning procedure of dispensing tools. PROCEDURE  PRODUCT-TO-PRODUCT CHANGE OVER  Scoops and spoons used during dispensing are immediately closed in a polythene cover after the activity and labeled as “To be Cleaned”.  Remove the tools in covered polythene bags of high density to the cleaning…

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Raw materials retest procedure OBJECTIVE  To establish the retest procedure for the raw material. SCOPE  This SOP is applicable to the approved raw materials in the Warehouse which must be subjected to retest. RESPONSIBILITY Warehouse Pharmacist and Warehouse Head shall be responsible for compliance with the procedure mentioned in this SOP. ACCOUNTABILITY Warehouse Head shall…

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Checking of the vehicle before loading finished goods To lay down a procedure and checklist for inspection of the vehicle(s) engaged in the transportation of finished goods, before loading at the warehouse of the manufacturing site begins. PROCEDURE The vehicle may be owned or a hired vehicle from authorized transporters. On receiving vehicle(s) for transportation…

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Handling of rejected materials OBJECTIVE: To lay down a procedure for handling the rejected material in the warehouse. SCOPE: This SOP is applicable for handling & disposal of rejected materials from the warehouse. RESPONSIBILITY: Warehouse, QC, and QA personnel shall be responsible for following the procedure mentioned in this SOP. ACCOUNTABILITY: The Warehouse In-Charge and…

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Сleaning schedule  OBJECTIVE: To lay down a standard procedure for cleaning the storage areas. SCOPE: This SOP is applicable for cleaning the storage areas.  RESPONSIBILITY: Store and housekeeping personnel shall be responsible for following the procedure mentioned in this SOP. ACCOUNTABILITY: Store in-charge and QA Head shall be accountable for compliance with the procedure mentioned…

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