PHARMACEUTICAL WARE HOUSING

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GLP and Ware Housing Procedures

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Presentation Transcript

WARE HOUSING:

WARE HOUSING A.SOLAIRAJAN M.PHARM (ANALYSIS) S.B.C.P 1

overview:

overview Definition Various processes of ware housing Designs House keeping Good warehousing practice 2

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WARE HOUSING AREA:

WARE HOUSING AREA 4

VARIOUS PROCESS OF WARE HOUSING:

VARIOUS PROCESS OF WARE HOUSING 5

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HOUSE KEEPING :

HOUSE KEEPING FREE FROM INSECTS PEST CONROL TREATMENT PROTECTIVE CLOTHING REJECTED MATERIALS CORRIDORS, WALKAWAYS,FIRE EXIT FREE FROM OBSTRUCTION 7

PREVENTION OF CROSS CONTAMINATION:

PREVENTION OF CROSS CONTAMINATION RECEIVING To prevent entry of contaminants SOP followed for each formulations Vacuum cleaning is preferable Packages must checked by QA personnel . SAMPLING To take a sample at a time. Air control system minimise the contamination Periodic validation and confirm effectiveness 8

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DISPENSING Detailed procedure for dispensing Must be equipped with dust extraction system Dispense material at a time Use clean scoops/measures for each material Effectively clean the weighing equipment and dispensing bench To prevent displacement of dust do not use fans during dispensing 9

GOOD WARE HOUSING PRACTICE:

GOOD WARE HOUSING PRACTICE It includes, Guidelines for receiving, verifying, inspecting all incoming materials. Premises for storage materials. Handling of raw & packaging materials. Weighing of materials for batch production. Storage and handling of finished goods. Stock control system. Processing of orders. Returned goods. 10

Receiving the materials:

Materials received with proper receipt. Each consignments clearly indicate Name of the material Name of the MFG/Supplier Batch number Quantity of the material Number of containers & their quantity Materials checked for cleanliness. All receipts entered into the ware housing systems for easy review. Each container of material labelled and indicate Serial number of the receipt Name of the material Total qty and no.of containers Date of receipt. All labels indicate Under test Awaiting approval 11 Receiving the materials

Premises for storage materials:

Premises for storage materials Ware house have separate areas of suitable size and construction for Receiving Sampling Storage Dispensing Rejected materials 12

STOCK CONROL SYSTEM:

STOCK CONROL SYSTEM Passed batches of products issued for distribution Stored in product-wise to find easy identification Stock rotation on ‘ FIRST IN, FIRST OUT’ BASIS Stocks easily racked and stored 13

PROCESSING OF ORDERS:

PROCESSING OF ORDERS Despatch of products in one consignment Arrangement of products and assemble it Minimise the picking and assembling areas travelled by ware house operators Picking stocks kept at convenient heights with proper labels and easy to identify Should arrange in the order of standards, dated and serially numbered documents Should be checked for accuracy of quantity and identity of products. 14

HANDLING OF FINISHED PRODUCTS:

HANDLING OF FINISHED PRODUCTS Outer packs prepared and packed for transport. Adequate precautions taken to prevent spoilage,breakage or pilferage in transit. Should not contaminate with other products. VEHICLES CARRYING PRODUCTS SHOULD BE Clean,dry and protected from rain and other factors Free from infestation Do not give unpleasant odours No weight variation before and after carrying 15

RETURNED GOODS:

RETURNED GOODS Returned stocks accounted by QC manager Returned goods with proper receipt and reasons for returning. Returned goods has checked by QC manager whether re-processing if required. Disposal of examined goods checked by QC manager. Destruction of goods done by designated person and details are recorded. Reprocessing of returned goods authorised by QC manager. 16

STORAGE:

STORAGE STORAGE OF RAW MATERIALS DONE BY TWO ASPECTS. GENERAL STORAGE AREA. SPECIAL STORAGE AREA. GENERAL STORAGE AREA:- Storage of raw materials when received. SPECIAL STORAGE AREA:- Special storage areas include controlled temperature and humidity conditions whether applicable. 17

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STORAGE MATERIALS ARE SEPARATED AS; UNTESTED UNDER TEST APPROVED REJECTED . Hazardous materials like Poisons,Corrosive chemicals,Flammable chemicals,Explosives should be kept under Authorised personnel and handling of chemicals also 18

STORAGE OF PACKAGING MATERIALS:

STORAGE OF PACKAGING MATERIALS Primary packaging materials like bottles, vials, ampoules,tin,tubes,foil,wrap etc should be stored free from dust and other extraneous matter . Printed labels and packing materials should be stored proper identity with respect to the package size. Similar looking labelling materials should not be stored adjacent to each other. Air conditioned areas should be provided for aluminium foils and other materials which are stored over a period of time. 19

HANDLING OF RAW MATERIALS & PACKAGING MATERIALS:

HANDLING OF RAW MATERIALS & PACKAGING MATERIALS RAW MATERIALS Material safety data sheets prepared for safety hazards Personnel protective devices like hand gloves,face masks should be used. All chemicals containers should always closed. Adequate dust extraction system provided to prevent cross contamination. PACKAGING MATERIALS Packaging materials should be issued to production only against authorised order. Unused packing materials should returned to the warehouse . 20

WEIGHING:

WEIGHING Weighing procedure should be clearly explained to all operators who handle equipment. Dust materials need efficient dust extraction systems to prevent spreading. Moisture sensitive materials should weighed in controlled humidity conditions. WEIGHING OPERATION :- Before weighing, the balance is must clean and no dust on the platform,weighing bowl,dial,beam . Balance must be checked by each day and accuracy is within the limits and keep the records for those checking. 21

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THE WEIGHING MATERIAL SHOULD CLEARLY LABELLED WITH Name of the material,code number,lot number, the number indicating QC release Name of the product,code number, batch number. Tare weight,gross weight, and net weight of the material should be noted. The labelled and indicated weights thoroughly checked before going for formulations . 22

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THANK YOU 23

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