Good warehousing practices (GWP) means storing supplies so that products are always available, accessible, and in good condition. Bad warehousing lead to damages resulting in losses.
Pharmaceutical warehousing, therefore, is much more than the simple storage of products.
Pharmaceuticals are stringently regulated by the Food and Drug Administration (FDA).
The FDA’s regulatory standards for the industry are referred to as Current Good Manufacturing Practice (CGMP) standards. These standards apply to warehouses, processes, and to the products themselves.
GWP is an integral part of the Good Manufacturing Practice (GMP) requirements for production purposes and of GLP for laboratories.
GWP principles were defined to improve the measuring process of weight in production as well as in pharmaceutical and biotechnology company laboratories.
Pharmaceuticals warehouse is responsible for receiving, storing, releasing of incoming goods (including labeling and packaging) as well as releasing and distribution of finished products.
Well, these 5 ‘S’ are – Sort, Set, Shine, Standardise and Sustain. Implementing the 5S practices is key to maintaining a lean warehouse.
The basic objective of implementing 5S is to make problems visible, thus creating a safer workplace.
Good warehousing practices (GWP) means storing supplies so that products are always available,
accessible, and in good condition. Bad warehousing lead to damages resulting in losses.
Pharmaceutical warehousing, therefore, is much more than the simple storage of products. It is an operation that preserves the integrity of drugs.
According to cGMP Drugs must be stored to prevent contamination, and be positioned to allow for inspection and cleaning of the area. Each lot of drug products must be identified with a distinctive (and traceable) code, and the lot’s status must be identified (approved, quarantined, rejected).
Written procedures must describe the distribution process for each drug. This includes procedures for recalls.
Written procedures must describe the appropriate storage conditions for each drug. Different drugs can have vastly different requirements in terms of temperature, humidity, and lighting.
The warehousing official ensures that the storage of each drug is in line with its specific requirements defined by the manufacturer.
This can involve temperature-controlled warehousing and/or climate-controlled warehousing space 20, both of which require state-of-the-art control and monitoring equipment to keep the space with in specific environmental parameters.
FUNCTIONS OF WAREHOUSING –
- Receiving and Recording of goods: While receiving the goods it is the responsibility of the warehouse department to check and verify the goods that are coming into the warehouse by weighing the shipper coming in and counting the same.
- The correctness and quantity of the goods coming in should be verified at the time of receipt and recorded in a document. It should be mutually agreed and signed between the person transferring the goods and the person receiving the goods.
- Storage: Major function of storage is to ensure that the product is protected and stored in a manner to ensure that the goods are easy to identify and as per the category. It is advisable to have zoning concept where the products can be stored as per the zone.
- Order Picking: After the receipt of the order the line manager shall ensure that he has picked the same order as indicated in the picking list and the same batch member should appear in all the documents i.e., the invoice, the picking list and the delivery note.
- Distribution: The line manager hand over the goods to the packers who verify the goods against the
delivery note and do the necessary marking on the shippers as per the customer. - It is the responsibility of the loading supervisor to check the vehicle and confirm that it is matching as per the requirements and is clean and tidy for loading pharmaceutical goods.
The incoming material in the warehouse to be immediately sent to quarantine.
The quarantine goods to be sampled by the Quality Department and sent for analysis. (In case of
manufacturing unit the samples may be taken online before the batch is transferred to Quarantine).
After getting release from the Quality Department the goods need to be transferred to the Approved area.
In case if the goods are rejected they are supposed to be transferred to the Rejected area the keys of the rejected area shall remain with the Quality Department.
There should also be provision for customer returned goods and market returned Goods which
should go through the Quality Department for further segregation into either approved or rejected.
Provision for goods to be stored under controlled temperature is a must.
General Instructions :
- Stores is the place where raw materials and packaging materials are received and stored at appropriate storage condition.
- Approved materials are dispensed to Manufacturing.
- After completion of Packaging, Stores received Finished Goods.
- Finished Goods are stored and dispatched against EPO.
- Do not bring or wear ornaments, watch, bracelet, mobile in Warehouse.
- In case of wound or illness, do not work in Stores.
- Clean shaved, short hair, trim nails.
- Take bath daily.
- Ensure lights, water / compressed air / steam connection are closed, while closing the department.
- In case of emergency, gather at assembly point.
- Wash hands before and after meals & After visit to wash room.
- Wear gown, hood, booties during processing & cleaning.
- Label equipment, area, ancillary according to stage.
- Use pallets / containers to keep material or items.
- Calibrate balance, prior to first use, once in a day.
- Keep wiper / mops on hanger in wash area.
- Do not touch product bare handed, use hand gloves.
- Discard polybag, cable tie, label, gloves in waste bin.
- Store the dispensed material in quarantine.
Environmental Monitoring –
- It is monitoring of temperature and relative humidity (RH), and differential pressure in processing area’s.
- All process area have defined temperature and RH limits.
- Controlled Temperature and RH is important, as it directly affects the product quality.
- Temperature : is the term used to define hotness or coldness in the environment. Unit for measurement is degree Celsius (°C) .
- RH is relative humidity :Percentage of water present in air in form of moisture is called as humidity. Unit for measurement is percentage RH (%RH) .
- How environmental monitoring is done?
- Thermo hygrometer is used to record temperature & RH .
- Temperature limit: NMT 28°C
- RH limit : NMT 60 %.
- In some cases temperature & RH limits are product specific.
- What is differential pressure.?
- Differential pressure is pressure gradient between to adjacent area.
- How differential pressure is recorded.?
- Magnehellic gauge is used to record differential pressure.
- Differential pressure limit: NLT 0.6 mm of water.
- Temperature of Raw Material Stores, Packaging Material Stores and Finished Goods Stores are displayed on the Temperature Monitoring System.
- If temperature exceeds hooter will alarm.
- Calibrate weighing Balance before first use in a day.
Receipt of Material :
On receipt of vehicle check Transport Documents for:
- Delivery challan, lorry receipt, invoice, (if applicable), COA (certificate of analysis) / COC (certificate of compliance)
- Custom Inward Entry on Invoice .
- Consignee Name on Documents.
- Manufacturer Name from approved vendor list.
- Purchase Order No., Name of Material, Quantity, No. of packs.
- Receive transport documents on arrival of vehicle.
- Materials are received at unloading bay (receipt area).
- Check vehicle condition.
- Solvents are unloaded at solvent storage area material Unloaded in the presence of security on clean pallets.
- The materials are segregated item wise, lot wise.
- Ensure manufacturer’s label has: •Name of material,•Quantity,•Batch no Mfg. & Exp. date,•Manufacturer name & site
- Check “integrity of packing” & “correctness of labeling” at the time of receipt of Material.
- In case Received pack is in “Damaged Condition”.
- Affix label of material received in “Damaged Condition”.
- Acknowledge receipt of material by stamping lorry receipt and filling the details.
- Check weight of consignment as per given unit of measurement (UOM) for example – kilogram (Kg), liter (Lt.) or number (No.)
- Intimate to QA through “intimation of damaged container / bag / pack”.
- Check the received consignment for physical weight.
- Record the details in “Receipt cum Inspection Report”.
- Verify Physical weight of with suppliers packing list (if mentioned).
- Check roll label by Number printed on reverse side of Label.
- Except identification label, deface all rest of labels on received pack by marking cross (X) Use marker pen & sign at right side bottom of label.
- Clean the outer surface of Containers / Box /Bag by passing thru De-dusting Tunnel.
- Preparation of GIM.
- GIM prepared by stores through SCM/SAP.
- In case of short receipt, Shortage Note is prepared through SCM/SAP.
- Affix “Quarantined” label on all received containers /bags /packs.
- Transfer Material in “Quarantine / Under Test” Area.
- Store material as per recommended storage condition.
- If material received in Paper bag or Woven sack bag, cover with fresh polythene bag over the material bag & close with cable tie.
Materials are stored as per storage condition :
- Temperature Sensitive Materials and certain Primary / Secondary Packaging materials are stored in controlled temperature area.
- Solvents are stored in “Solvent Storage” area.
- Labels are stored in Pigeon- hole Almirah under Lock & Key.
- Only one item code labels are stored in one locker.
- Quarantined materials are sampled by QC and affix “Under Test”.
- After analysis by QC, material is either “Approved” or “Rejected”.
- On approval of material, QC affix “Approved” label on container / bag / pack.
- Material transferred to “Approved” area.
ELEMENTS OF GOOD WAREHOUSING PRACTICES :
Costs involved in warehouse:
As a practice it is good to follow first expiry first out (FEFO) for the finished goods, which helps to maintain the inventory with the maximum shelf life FIFO is also equally valid as FEFO.
The imported goods need to be scrutinized and checked for expiry dates at the time of receipt.
Physical Stock Verification:
Orderly, timely and frequent stock verification is the key to correct stocks and the same affect the business positively.
The warehouse must on a routine basis share the data on the non moving, dead stock and the near expiry products so that the management can take a decision on the fate of the drugs.
The data collected from the stock review should also be shared with the supply chain and planning Department regular basis so as to facilitate in an effective planning process.
Safety in Warehouse :
Safety is of foremost important in a warehouse considering the various types of activities and
equipment like the forklift, Trolley, pallets drums shippers etc. Some are kept at a height which if not stored properly can be precarious and lead to fatal accidents.
OHSASZ 21guidelines need to be followed religiously and all the employees should wear protective garments commonly called PPE 22, to protect them from any accidental harm. Helmets, Safety shoes, garments, masks are necessary.
Abrupt and rapid movements are uncalled for and cause more damage than benefits. So the warehouse employees need to be disciplined and cautious in their approach.
Any and every accident should be reported immediately. The fire end emergency exit plans shall be well laid out and fire drills to be performed to validate the exit plan.
The entire warehouse has to be subjected for pest control activities and the rodent baits should be checked at regular intervals.The boats 23 and chemicals should be kept away from the pharmaceutical preparations and at any given point should not come in contact with the workmen of the products kept in the area.
Premises, Health & Hygiene :
The area should be kept clean and away from objectionable odors. smoke dust and other contaminants.
The warehouse should be well ventilated. It should protect the goods from adverse weather conditions. Opening leading to entry of rodents, pests, birds and vermin should be closed.
Floors should be non slip evenly graded to prevent stagnation and can be drained to trapped outlets protected by a grill.
The floor should be constructed using material that is impervious, non-toxic, non adsorbent and crack resistant. Walls should be made of smooth,durable, impervious,non adsorbent and crack . resistant
material that can be cleaned easily.
All ceiling are to be constructed and finished so as to prevent condensation, leakage and formation of molds and should be easily and regularly cleaned. Door should be easily cleanable surfaces.
Adequate lighting and lux NLT 350 levels. Toilets must not open directly into any place where the products are stored. The recommended storage conditions for the cold storage is 2-8° C. which should be mapped and the temperature sensor to be placed at the hot spot identified manual temperature recording.
Cold storage should not be overloaded should have racks inside for proper storage. It should be in
sanitary condition at all times.
The cleaning equipment should be placed in a well designated area with proper labelling. Eating, drinking smokin, chewing gum or tobacco, littering and undesirable behavior at the designated areas in the premises is prohibited.
Any person who has open wounds and lesions, boils sores or infectious disease must be sent on leave till they achieve complete recovery Attested by a medical supervisor.
Good documentation:
Last but not the least is the documentation for the activities done. It is a common saying in GMP that “if it is not documented it never happened”. SOP, records & Bin card need to be checked, updated and religiously followed. Maintain the invoices, delivery notes and other documents.
