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Dear Pharma Veterans. This series of Blogs is a summary view of Pharma Business in Pakistan. It is a series spread over several parts covering the entire spectrum of Pharma business.
Pharma Business – OPERATIONS – WAREHOUSING
Warehouses are another area which is regulated under the GMP guidelines. It is always part of any ‘qualification inspection’.
Warehousing is much more than just storing the goods. Warehousing has evolved over time to become a scientific subject in all respects.
- Current regulations dictate that a qualified pharmacist must run the warehouse.
- The environment should generally be controlled for temperature and humidity. It is recommended to have proper HVAC system in warehouse.
- The temperature and humidity should be recorded at regular intervals and a log be maintained which should always be ready for inspection.
- For materials requiring low temperature storage, separate space should be allocated and maintained.
- Some materials are to be stored in refrigerator. Adequately sized, commercial refrigerator(s) should be provided for this purpose.
- The warehouses must be protected from insects and rodents. Regular fumigation should be carried out.
- All warehouses should follow FIFO (First In, First Out) principals. Failing to follow FIFO may lead to materials getting expired unknowingly, causing undue losses.
- All incoming materials are put in the quarantine area. The QA takes samples and sends to QC for testing. Materials that are passed and released by QC are stored in the warehouses; rejected materials go to rejected materials store.
- All materials movement has to be recorded. Previously, it was Bin Cards and manual entries; now it computerized. More and more companies are now using ERP and warehouse management is part of the software.
- Pharma materials and finished goods cannot be kept directly on the floor. These have to be stacked in proper racks. Racking increases the warehousing space manifold, is clean to look at and makes warehouse management easy.
- Materials which may not be stored on racks due to size or volume, must be put on pallets and then kept on floor, or on pallet racks.
- Warehousing space will never be enough. New concepts in warehousing are coming in which claim to increase storage space significantly. These should be studied and adopted wherever possible.
Warehouses in Pharma
Following storage spaces are recognized as ‘dedicated’ warehouses.
- Raw Material Warehouse
- Packaging Material Warehouse
- Finished Goods Warehouse
- Cold room – for cold chain products 2 – 8 Co
It is true that warehouses in many companies are poorly organized and even more poorly managed. Warehouse staff is usually least qualified and least paid, with the result that the overall operation is highly inefficient.
Present Challenges in Pharma Warehouses and Their Solutions
- Space Utilization – First of all, enough space is usually not allocated, because there is competition for space in production area. Manufacturing and packaging operations take priority for space and whatever is left is used for warehousing. This conventional thinking must change. Adequate space should be allocated for warehouses. Available space should be fully utilized with the use of floor-to-ceiling shelving, racking and pallet racking. Multiple firms are offering to design and install custom-built racking systems whose services may be utilized.
- Stock Identification – This is a void area currently. Bin cards are gone and there is no physical identity tool for the stored stock. The warehouse staff has to rely on shipper labels to identify stock. This is a challenge because all shipper labels cannot be seen due to distance or poor visibility. Another reason is that the shippers are stacked one behind the other and the label is not visible at all. Technologies such as RFID are now available at low cost to make stock identification accurate and efficient.
- Stock Picking – Probably the most variable and disorganized activity seen in the Pharma warehouses is how the stock is picked up. Mostly, first the stock is picked up on the basis of products and quantities and put somewhere in the middle of warehouse. Then the batch numbers etc. are entered into computer to generate invoice. There is a great likelihood of missing FIFO and mixing up batches. The right way is to first make the invoice through system and let the system pick up batches as per FIFO. The warehouse staff should receive a copy of invoice and pick the stock.
- Automation, or lack of – Presently, Pharma warehouses are not automated in any sense. We are probably very far from using robotic trolleys and the like; but should we be? Larger companies must consider automation to increase efficiency.
- Emphasis on Manual Labor – There is a tendency to increase number of workers in the warehouse to increase productivity. This is counterintuitive and often counterproductive. Rush of workers may actually reduce productivity. Emphasis should shift to better staff training, use of technology and improvement of systems to increase productivity.
- Warehouse Equipment, or lack of – Pharma warehouses are least equipped. The staff works mostly with ladders and sometimes manual trolleys. Hydraulic forklifts are seen sparingly; electric forklifts are not seen. Use of proper equipment shall increase productivity.
- Operational Improvements – Continuous improvement of processes is missing and must be adopted for better efficiency. Staff training is another missed area which can bring significant improvement. Documentation, software and reporting needs to be continually upgraded.
Warehousing is a critical component of Supply Chain, with the potential to disrupt the chain, if not working optimally. Warehousing should be given importance at par with other parts. Failing to do this, the ultimate delivery, time to delivery, and cost of delivery will not be used to the advantage of organization.