1. What is the role of Warehouse in Pharmaceuticals :
Warehouse in pharmaceutical plays an important role which includes Receiving of Raw material, Packing material, Finished products, Storage of materials in required storage condition (Temperature and RH), Dispensing of Raw and Packing materials which are required for manufacturing of the batches , Dispatch of Finished (the products which completed all stages i.e. manufacturing and Final packing) products.
2. What is Good Warehouse Practices (GWP):
Good Warehouse Practices (GWP) includes Entry and Exit to warehouse with proper gowning, Receiving and storage of materials in required storage condition, Proper Labeling of Raw and packing materials, Systematic arrangement of materials in warehouse, Use of required personnel protective equipment during dispensing of materials, Storage of controlled drug substances, Training of persons working in warehouse, Verification of Incoming materials with respect to Quantity and damage, Sampling and testing of materials, Handling of Returned and expiry materials and dispatch of Finished goods to market.
3. What are to be checked Before Receipt of Raw and Primary Packing Materials :
Before and receipt of materials below details to be checked:
- Check the documents for correct company address which is mentioned on the Delivery challan or Excise Invoice.
- Check the Purchase Order provided by purchase department and verifies that the material received is as per order. Quantity supplied as per challan is confirmed against the ordered quantity.
- Check whether vendor is approved or not from the Approved vendor list or Provisionally Approved Vendor list provided by Quality Assurance Department.
- Check availability of Vendors Certificate of Analysis. If not available, inform to Purchase Department and Department Head and hold the vehicle till further decision.
- Checklist for Receipt of Materials to be filled by Warehouse person & allow for unloading.
- After unloading verify whole consignment against the provided document (challan copy ,Invoice Copy ,Vendor COA .) for its vendor batch/Lot number ,manufacturing Date ,Expiry Date, Retest Date ,manufacturer name ,manufacturer address ,Gross weight ,Tare Weight and net weight .
- If any damage or deshaped or defaced container or any other discrepancies noted, same shall be reported to QA department through Damage Report.
- Deface the Manufacturer Approved label if any by permanent marker pen by doing cross mark and De-dusting of material containers shall be done with the help of De-Dusting machine.
- 100 % weight verification shall be done for Active Ingredients, Excipients, Aluminium foils, PVC films, PVC / PVDC, films, cotton, rayon coil, ploybags etc.
- After Physical Weight Verification transfer clean material containers on HDPE pallet and affix status label on each pallet as Awaiting for GRN and and transfer these material pallets to Staging Area.
- Then Prepare Goods Receipt Note (GRN).
4. What Goods Receipt Note (GRN) Contains :
- Goods Receipt Note (GRN) Contains GRN Number, GRN Date, Purchase Order Number, Purchase order date, Challan / Invoice Number, Challan / Invoice date, Material Code, Material Description, Manufacturer Batch / Lot Number, Manufacture name, Manufacturing date, Expiry date, Qty. Received, Number of containers or boxes and A.R Number.
- Warehouse person fill the GRN and Submit copies to QC along with vendor COA, then Quality control will assign Analytical reference number and sign on the GRN copies and retain original copy of GRN along with COA and keep the duplicate copy with Him/Her.
- Quality control has to perform sampling after receipt of GRN copy.
5. How materials are destroyed in Warehouse :
- All raw materials shall be dissolved as per Material safety Data Sheet Bulk container shall be deshaped /crushed and collect in double layered poly bag and sent it to scrap yard.
- Aluminium, shrink wrap roll and PVC/ PVDC foil shall be defoiled and cut into the piece and collect in a double layer poly bag and send it to scrap yard.
- Carton, Leaflet, printed sticker lable, shipper, silica gel bag etc. shall be destroyed by manually torn / shredding and send it to scrap yard.
- All destruction activities shall be performed after approval from quality assurance and plant head and in the presence of Quality assurance person. Stores person shall prepare Destroyed material handover to Environmental Health Safety Department and handover the rejected material to EHS department for disposal.
6. What are the reasons of Materials rejection in warehouse :
- Rejects due to damage at the time of receipt or damaged during handling.
- Material rejects during Quality Control testing.
- Online Rejection
- Material rejects during retesting
- Approved material expired during storage.
- Obsolete materials (No longer appropriate for the purpose of use either due to the availability of better alternatives) .
7. How to Handle the Approved Expired Materials:
- Every first (1st) week of month Stores person shall prepare a list of materials which are going to expire in next 60 days. Warehouse person has Inform to Head Production, Head QA and Purchase Department about near expiry materials.
- Stores person shall affix Expired label on the container of Expired material by doing cross mark on present status label, on the day of expiry date and then transfer expired materials from approved storage location to reject room.
- After getting approval for destruction on “Destruction Approval Form” Material shall be destroyed in presence of Quality Assurance.
8. How to Handle Spillage of Solid Materials in warehouse:
- If any spillage observed, Raw Material Store person shall segregate the damage container from other containers to avoid contamination and immediately inform to Department Head and Head Quality Assurance.
- With the help of vacuum cleaner or dry mop collect the spilled material by taking sufficient safety precautions i.e. wear safety goggles, nose mask, hand gloves etc.
- As per instructions from Head Quality Assurance and Department Head transfer the content of damaged container or bag to another good container or bag then Weigh and note the quantity of the spilled material and destroyed as per MSDS. Fill the destruction note and destroyed the spilled material in presence of Quality Assurance person and sign on the destruction note.
9. Checkpoints during dispensing of Raw and Primary Packing material:
- Switch “ON” the Reverse Laminar Air Flow Unit at least 20 minutes prior to start of dispensing / sampling activity and take the line clearance of the area from Quality Assurance person.
- Update the area status board and ensure the cleanliness of the area, Pressure differential, Temperature and Relative Humidity of the area is within limit and ensure that all the materials are approved.
- Ensure the calibration status of Weighing Balances and respective logbook of the area to be checked for completeness of all entries.
- Transfer Material containers to dispensing room through “Material Entry” of respective dispensing area.
- Check material details like material code, Material description, A. R. No., Mfg. Date, Expiry Date, Retest Date, Manufacturer Name etc. from the container label.
- Take tare weight of double polythene bags, double cable tie and dispensing label and dispense the required quantity (net weight) of materials as per Material Requisition Note under RLAF by using clean scoops / spatulas.
- After completion of dispensing activity, affix loose label to loose container and transfer loose containers to raw material store through material entry of respective dispensing area.
- Aluminum foil, PVC foil, PVC/PVDC shall be weight individual under RLAF on weighing balance and issue the quantity equal or more than the quantity mentioned in the batch record and affix dispensing label to individual roll.
10. Checkpoints during Dispatch of Finished Goods:
- Finished Goods Store person shall prepare packing list for finished goods to be dispatch and Send packing list to commercial department and marketing department for completion of dispatch related documentation activity.
- Thorough inspection on arrival of container / vehicle, before & after loading of goods shall be done. Ensure cleanliness of container / vehicle, absence of any other materials or corrosive items , abnormal odour, dirt & holes etc. which can contaminate the goods.
- If palletization requires to be done, arrange the finished product shippers on plastic pallet or Certified heat treated wooden pallets and after completion of wrapping and strapping put identification labels on each pallet.
- Load the palletized finished goods inside the container/vehicle with the help of pallet trolley, by taking one by one palletized finished goods through loading bay and dispatch approved finished goods as per dispatch order.
- Place activated data loggers in loose shipper and if loose shipper not available, place activated data logger in fully filled shipper and ensure that two data loggers shall be kept in each container / vehicle.
- Close the door and seal the container and ensure that the thermostat on the refer container is get to run between 18-20 °C.
- Take photograph of sealed container / vehicle and Collect Finished Goods Certificate of Analysis (COA) from QA and Handover dispatch documents along with finished product COA to lorry driver.