| Issuance Of Raw Materials |
1.0 OBJECTIVE 1.1 To describe the procedure for proper assembling of the raw materials (RM) to be dispensing on First In First Out (FIFO) or First Expiry First Out (FEFO) basis, preparation in dispensing room before starting dispensing activities, to describe sequential order for RM dispensing, return of balance RM container and clean-up procedure of dispensing room after dispensing. 2.0 SCOPE 2.1 This procedure shall be applicable for issuance of all Raw Materials used in the plant. 3.0 RESPONSIBILITY 3.1 Implementation & Execution: Warehouse Officer 4.0 ACCOUNTABILITY 4.1 Head –Warehouse 5.0 PROCEDURE 5.1 Verification of availability of Raw materials as per requirement 5.1.1 On receipt of Authorized Batch Manufacturing Record, according to dispensing sheet dispensing chemist shall verify the availability of the stock for the items against requisition. 5.1.2 If the sufficient stock does not available, arrange for the procurement and inform to respective department. 5.1.3 Take printout of system generated raw material requisition slip and get approval of that by authorized person. 5.1.4 If the stock of the item related to the batch is available, prepare the dispensing Tag which indicates item name, net quantity, tare weight, gross quantity, product, batch number, AR number, and date issued by and checked by details. 5.2 Assembling of the RM containers 5.2.1 Take out the respective material(s) from the approved RM Store and collect it on clean pallet. If pallet is not clean get it cleaned properly. 5.2.2 Check the approved RM container(s) for the item name with specification, Batch no., Mfg. Date, Exp. Date, analytical report no., and retest date. When retest date is due, material should be shifted to “Quarantine area” and ensure that the same is not appearing in the approved stock. 5.2.3 Bring all the material(s) in staging room and keep it in pre-designated places. 5.2.4 Clean the outer surface of RM container(s) with the help of damp cloth to remove any deposit of dust or foreign particles. 5.2.5 Take container(s) of one material only at a time in to dispensing room through material entry only. To Read this SOP click here SOP for Procedure For Testing Water Hardness. 5.3 Verification of dispensing area 5.3.1 Enter the dispensing room as per the respective SOP. 5.3.2 Check and verify the dispensing room with regards to cleanliness of the following: Floor, Door, Wall RLAF Unit Balance & SS cupboards Dispensing device/Utensils Tube lights and fixtures Supply & return air duct Ceiling 5.3.3 If any of the above items are not clean, get it cleaned as per SOP-WH020 before starting the dispensing operation. 5.3.4 Before starting the RLAF ensure the needle of manometer is at 0.0 mm of WC. Switch on the RLAF unit prior to 30 minute before starting the dispensing operation. 5.3.5 Check the record for following details. 5.3.5.1 Room temperature and humidity. 5.3.5.2 Cleaning records. 5.3.5.3 Balance verification record. 5.3.5.4 RLAF-Magnehelic gauge/Manometer reading across HEPA filter and across pre-filters. 5.3.5.5 Ensure proper cleaning of area and equipment’s after every material change as per checklist (Annexure-II) and maintain the record. 5.4 Dispensing of the raw material(RM) 5.4.1 Dispensing of RM is to be carried out by Warehouse personnel in the presence of Production personnel and QA personnel. 5.5 Dispensing in Warehouse 5.5.1 Check the record of daily verification of balance. 5.5.2 Bring the container(s) of one of the material inside the dispensing room as per 5.2.5 one after another for dispensing to avoid cross contamination. 5.5.3 Use one dispensing device (scoops/spoons) of appropriate size for each raw materials and after use; place it in the container identified with “USED UTENSILS- TO BE CLEANED”. Note: While weighing every raw materials, take maximum precaution for accurate Weighing and avoid spillage of material. Closing and opening of container, as well as dispensed packs shall be carried out under RLAF only. Dispense all inactive ingredients first and active ingredients at last. Clean the area before the changeover of product. Prior to dispensing, record the cleaning in Annexure-I. Light sensitive raw materials shall be dispensed in /or covered with a black coloured polythene bag or shall be stored in closed cage immediately after dispensing in order to avoid excessive exposure to light. 5.6 Handling and Issuance of Inflammables and Hazardous Materials 5.6.1 Take special precaution while dispensing liquid materials and solvents. Use drum opener, solvents delivery pump, drum tilter for the hazardous materials. 5.6.2 All inflammable and hazardous materials shall be stored in a separate place. 5.6.3 Inflammable materials shall be kept away from electric connections and gas connections. 5.6.4 Adequate facilities shall be provided in emergency such as extinguishers, water tank and sand etc. 5.6.5 The storage area of inflammables & hazardous material shall have sufficient air circulation. 5.6.6 The person handling these materials shall be well trained in storing and issuance. 5.6.7 Dispensing of solvents shall be done in solvent room with the help of solvent delivery pump and weight. 5.6.8 The containers of these materials shall be closed airtight immediately after use and shall keep properly in its appropriate place. 5.6.9 Use SS container, jars or Beakers in case of liquid and solvents etc. 5.6.10 Record the weight of dispensed material after every weighing in dispensing sheet of their respective Batch Manufacturing Record and counter sign in respective columns of warehouse and production. Affix “Dispensing Tag” . 5.6.11 Transfer the solvents through the solvents nozzle in to the SS solvent container. 5.6.12 For use the container and pump etc. as dedicated items for a material. If switching over to other material is required then thoroughly clean these items. 5.7 Labelling of the dispensed materials 5.7.1 Place the store issue tag between two poly bags of respective dispensed material. 5.7.2 Tie-up the dispensed material bags with appropriate fastening device like pilfer proof cable tie or non-shredding nylon string. 5.8 Transfer of the dispensed materials to production area 5.8.1 Keep the dispensed material containers(s) on Pallets for individual batch of product with appropriate identification Dispensing tag. 5.8.2 Dispensed Materials is transferred to the production department. Inform respective production personnel to take the dispensed material in their custody. 5.8.3 Submit original batch sheet to the respective Production personnel after ensuring the signature of warehouse, production and QA personnel. 5.9 Return of the remaining ingredient containers to their respective location 5.9.1 Cable tie the polythene bag after twisting the open end, closes the container lid, containing remaining ingredients and secure it by cable tie under RLAF only. Weigh the container and record the gross weight and net weight on the ‘Loose’ label affixed on the container and sign the label. The loose label contains other particulars i.e. item code, item name, & AR number. Place the material container(s) in its original place as per location chart. 5.10 Cleaning of dispensing room after completion of the dispensing activities 5.10.1 Keep the used utensils in the container and move by tacking in to the washing area duly label as “USED UTENSILS-TO BE CLEANED”. 5.10.2 Wear a fresh pair of gloves. 5.10.3 Hold the used utensil etc under the flow of water till the surface is free from adhered particles and then scrub with gloved hands / brush with 0.1% Teepol Solution till it is visually clean and flush again with plenty of water. 5.10.4 Wash thoroughly the inner surface of Pipette, Measuring jars, barrel pumps by flushing with Purified water through the inner surface at least for one minute or more. 5.10.5 Spray with 70% IPA for disinfections. 5.10.6 After cooling, stretch wrap individually with the help of stretch film and place the utensils in polythene bag, cable tie it and keep in the crate / bin labeled as “CLEANED UTENSILS – READY FOR USE”. The equipment’s are cleaned every day after the day’s operation. In any case, if dispensing activity is not carried out for several days, then the equipment’s shall be cleaned prior to every 72 hours. |
