Good Warehouse Practice.pptx

it is important for pharma

1. PRESENTATION ON: GOOD WAREHOUSING PRACTICE AND ONGOING MONITORING BY MD. MIZANUR RAHMAN QA INCHARGE

2. GOOD WAREHOUSING PRACTICE CONTENTS INTRODUCTION WHAT IS WAREHOUSE MANAGEMENT VARIOUS AREAS OF WAREHOUSING DESIGN SECURITY TEMPERATURE AND HUMIDITY CONTROL FLOWCHART OF INCOMING GOODS RULES FOR WAREHOUSING CHARACTERS OF GOOD WAREHOUSE THE WAREHOUSE STAFF STORAGE CONDITION SAFETY MEASURES HANDLING AND ISSUE STOCK MANAGEMENT

3. 1. Introduction Maintaining proper storage condition for pharmaceutical products. Factory stores will invariably be receiving duly approved raw materials and packaging materials from the approved vendor. A suitable space is provided to handling and storage of raw & packaging materials required for manufacturing. This space is known as Warehouse . GOOD WAREHOUSING PRACTICE

4. 2. WHAT IS WAREHOUSE MANAGEMENT Warehouse management is the act of organizing and controlling everything within your warehouse and making sure it all runs in the most optimal way possible . This includes :- Arranging the warehouse and its inventory Having and maintaining the appropriate equipment Managing new stock coming in facility Picking , packaging and shipping Storing of Pharmaceutical Products in appropriate storage area. Tracking and improving overall warehouse performance GOOD WAREHOUSING PRACTICE

5. 3. Various Areas Of Warehousing Receiving Area - includes initial inspection , cleaning & weight checking Quarantine Area- A   quarantine area is an   area for storing goods that have not yet been inspected or tested. Sampling Area- Sampling area is a area where collection of small portion of a material with adequate facilities to prevent cross contamination. Storage Area - I ncluding specific storage like air condition rooms , cold rooms , hazardous chemical room . Dispensing Area – W ith adequate facilities to minimize cross contamination during dispensing . Rejected Area – Destroy or retented unsuitable or expired materials. GOOD WAREHOUSING PRACTICE

6. General : The layout and design of premises must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross contamination, build-up of dust or dirt. Where dust is generated (e.g. During Receiving, during sampling, weighing), measures should be taken to avoid cross contamination and facilitate cleaning . GOOD WAREHOUSING PRACTICE 4. DESIGN: Principle : Premises must be Located , Designed , Constructed, Adapted, and maintained to suit the Operations to be carried out . Good Warehousing

7. Continued….. Premises should be cleaned and , where applicable , disinfected according to detailed written procedure . Record should be maintained. Premises should be designed to ensure the logical flow of materials and personnel Premises should be designed and equipped so as to afford maximum protection against the entry of birds , insects , or other animals There should be standard procedure to prevent from rodent and pest control. GOOD WAREHOUSING PRACTICE

8.   5. SECURITY Storage areas should be provided with security to prevent theft or unauthorized entry Maintain a control of who may enter the facilities Establish system for controlling access to the facility (including all entrances and exits)  GOOD WAREHOUSING PRACTICE

9. 6. TEMPERATURE AND HUMIDITY CONTROL All materials must be stored at appropriate conditions as stated on the label of the material The temperature of all storage areas should be regularly monitored and recorded Controlled temperature storage areas should be equipped with recorders and devices which indicate when the specific temperature range has not been maintained A written procedure must specify the action to be taken when this occurs Control should be adequate to ensure that all parts of the storage area are kept within the specified temperature range Should always be a back up system in case main system fails GOOD WAREHOUSING PRACTICE

10. GOOD WAREHOUSING PRACTICE

11. 7. Flowchart of Incoming Goods RECEIPT OF INCOMING GOODS It should be carried out according to approved SOP : Visually examine delivery documents of the consignment delivery challan /Invoice COA Name of material Name of manufacturer Batch no Manufacturing date Expiry date Quantity Gross Weight GOOD WAREHOUSING PRACTICE

12. Continued…… Visually examine physical condition & verification of consignment for damage . Check the cleanliness Check the storage condition of materials Cross verify container labels with documents If any discrepancies is observed in doc, material, packing, vehicle condition, then warehouse officer should bring notice this to head warehouse & QA. GOOD WAREHOUSING PRACTICE

13. Quarantine of Received Goods Palletized the Raw Material containers/boxes in Quarantine area and enter record in the Quarantine Area Control Log Book . Affix “ QUARANTINE” label on each container/box Inform to the QC Department for sampling purpose with Sample Request Form . Sampling of Quarantined Goods Transfer the containers/boxes from Quarantine Area to Sampling Area and Take Sample as per SOP of Sampling and Handling of Raw and Packaging Materials. After Sampling affix “SAMPLED” label on the container/box and transfer the Sample to the QC Department for testing purpose. Then transfer back the materials to the Quarantine area. GOOD WAREHOUSING PRACTICE

14. Approval or Rejection of Sampled Goods QC Department will approve or reject the material as per test result. Affix an “APPROVED” or “REJECTED” label, whichever applies . Transfer approved containers/boxes from Quarantine area to the APPROVED warehouse & Rejected containers/boxes to the REJECTED store . GOOD WAREHOUSING PRACTICE

15. 8 . Rules For Warehousing Systematic storage of the delivered goods . Providing each products have only one specific place . On shelves clear labeling of products should be there . Adequate space should be provided for each goods . Provide separate BIN CARD for each products . All boxes in stock should be closed in air tight . Warehouse Mapping should be carried out. Flammable products should stored in separate place. GOOD WAREHOUSING PRACTICE

16. 9 . Characters of Good Warehouse Properly cleaned . Good preservation of drugs and equipment. Provide safety for staff and stocked goods . Control of air, light, humidity and temperature. Products to be purchased according to needs. Order the destruction of unsuitable products. Use of pharmaceutical products with FIFO/FEFO. GOOD WAREHOUSING PRACTICE

17. 10. The Warehouse Staff 1. The responsible Incharge His duties Good management of the stock of the warehouse. Good preservation of drugs and equipment's. Safety of stored goods. 2. The warehouse keeper His duties Reception of supplies. Storage of stocks of goods. Recording of every IN and OUT movement of the products in the BIN CARD. Issue of products during manufacturing. GOOD WAREHOUSING PRACTICE

18. Continued…. 3 . The warehouse worker His duties Handling operations includes the carrying and moving of goods which are intended for storage, shipment and sale. The warehouse staff helps in receives and issue goods and maintain inventory. 4. The cleaner His duty Appropriate cleaning by given procedure. Ensure cleanliness of premises and equipment. use air curtains and air tunnels. GOOD WAREHOUSING PRACTICE

19. 11. Storage Condition There are several types of storage conditions: Controlled Condition (15ºC – 25ºC) Cool Condition (8ºC – 15ºC) Cold Condition(2ºC – 8 ºC) Freezer Condition (Bellow –18ºC ) Note : Temperature Mapping must be performed in the storage area and the Temperature Mapping should be performed in Two seasons (Summer and Winter ). Refrigerator and Freezer must be validated for storing. GOOD WAREHOUSING PRACTICE

20. 12. Safety Measures Ensure safety equipment are being used Eliminate any potential safety hazards Control electrical hazards Clearly label designated hazardous zones Inspect ladders before use Be emergency ready Implement safeguards Respiratory protective equipment Proper safety procedures Preventive maintenance GOOD WAREHOUSING PRACTICE

21. 13. Handling and Issue Raw Materials Attention to be made for – prevent cross contamination, health of personal handling material, containers should be closed properly. Materials issued only against authorized person . Personnel protective devices like gloves, facemask etc. should be used to avoid health hazards. Adequate dust extraction system should be provided to suck away fine dust as to prevent cross contamination. GOOD WAREHOUSING PRACTICE

22. Packaging Materials Packaging materials issued to production only against packaging materials order. Care should made to check for only right packaging materials to be issued. Unlike raw materials , exact quantity of packaging materials to be issued. Unused packaging materials returned to the warehouse and will accompanied by authorized documents . GOOD WAREHOUSING PRACTICE

23. Finished Products Safe, orderly and dispatch of all products cold storage area have temperature monitoring and recording device racking and shelving system should have good mechanical strength Stock received from factory with proper documentation [name, batch number, batch size etc.] Stock should be stored product wise to enable quick identification and controlled stock movement Store rotation should be on –FIFO/FEFO. GOOD WAREHOUSING PRACTICE

24. Returned Goods Stock should be carry out only consultation with Q uality A ssurance Incharge . Returned goods must be isolated on receipt , clearly identified and records regarding reason for the return . QC personnel separately sampling the returned product for analysis. QC Incharge should examine whether these goods are reprocessed or destroyed. Reprocessing of returned should be done according the instruction of QA Incharge . GOOD WAREHOUSING PRACTICE

25. 14. Stock Management Objectives :- To ensure continuity of supplies To avoid over stocking Monitor stock levels Monitor consumption Issuing o f Materials :- Store should issue raw and packaging materials on the basis of FIFO (first In, first out) or FEFO (First Expired, First Out) basis. Entry and exist of every consignment of materials should be entered on the BIN CARD. Issuing of materials should do on the basis of raw and packaging materials required in manufacturing process . While issuing hazardous and explosive materials . The operation should be supervised to prevent any mistake . GOOD WAREHOUSING PRACTICE

26. You learn from experience You learn better from bad experience