A Seminar OnPharmaceutical Warehousing Prepared By: Ravi Akhani (M.Pharm (Q.A.), Semester-1) Guided By: (1) Mr. Rajesh Parmar
Contents:1. Objective2. A pharmaceutical warehouse: for what?3. Premises4. Storage condition5. Shelf life of the product6. General requirement for warehousing7. Stock management8. Documentation9. Inventories10. Reception of goods11. The warehouse staff12. Quality assurance13. Audits
1. Objective:- - Factory stores will invariably be receiving duly approved raw materials and packaging materials from third party. - A suitable space is provided to raw material and packaging materials for each contract manufacturer. This space is known as Warehouse.
2. A pharmaceutical warehouse: for what?- To enable the fastest and cheapest transport of drugs and medical equipment from suppliers to beneficiaries. - There are mainly 3 stages: (1) Purchase of pharmaceutical products (2) Storage of ordered products (3) Distribution of stocked products
3. Premises:- - Principle: Premises must be locked, designed, constructed, adapted, and maintained to suit the operations to be carried out.
4. Storage condition:- A. Temperature - Daily monitoring and recorded every house. - Temp. in warehouse must not exceed 25-30oC. B. Air - All containers should be hermetically closed. - Avoid prolonged unpack age material. - Premises should be ventilated. C. Light - Many API should be stored in dark room. - API should not be directly exposed to sunlight and not to be issued until and unless it is required in manufacturing.
5. Shelf life of the product:- A. Expiry Date - It must appear on the package and/or on the product. - The expiration date applies to a drug in its original closed and undamaged package or container. B. Management of outdated products - First, the expired products must be removed from the stock of the products. Stored in a locked area. - Secondly, these products are stored by form to be destroyed in compliance with law and regulations.
6. General requirement for warehousing:- - Clean the premises with disinfectants. - To clean the ground surface regularly. - To clean the undergrowth from around the warehouse regularly. - Smoking and eating must be forbidden in the premises. - Facility of locking doors and protective windows. - To provide extinguishers to fight fires. - To fight against pests. - Adapted and functional lighting as well as generators ready to works.
7. Stock management:- - Objectives (1) To ensure continuity of supplies (2) To avoid over stocking - Stock management will set out to; (1) Monitor stock levels (2) Monitor consumption (3) Anticipate delivery time for order activation.
8. Documentation:- - Stock card Definition:- It is a simple and efficient tool that enables the management of a warehouse. A stock card should be created for each pharmaceutical product and regularly updated. They must be easily accessible. It is necessary to: - Identify stock movement: incoming and outgoing products - Know the theoretical stock level at any point in time - Monitor the consumption of the different users - Monitor expiry dates - Assess losses by comparing the theoretical and real stocks - Have data to plan subsequent orders.
9. Inventories:- Why do them - It is essential to make an inventory of the quantities that really are in stock. - Mistakes, omission or thefts can explain the differences between the theoretical and real stock. Those differences should of course be cleared up. - Inventory makes it possible to check the expiry dates of all the pharmaceutical products. How to do them? - Inventories should be made on a regular basis with a frequency defined by a procedure specific to each warehouse. - On the day of the inventory, all activities should be stopped except the counting of stocks: NO IN OR OUT MOVEMENT OF PRODUCTES on that day. - The inventory should be conducted in a minimum time and the results should immediately be recorded to enable normal working to resume.
10. Reception of goods:- Inspection of an order - A separate rack should be provided to store approved raw and packaging materials. Materials that are waiting for approval should be kept in “Quarantine area”. - After receiving approval, it should be taken into stock. Quarantine materials should be labeled “Under Test” till it released by Quality control division.
11. The warehouse staff:- (1) The responsible pharmacist (2) The warehouse keeper (3) The warehouse worker (4) The cleaner (5) The security guard
12. Quality Assurance:- SOPs Each warehouse will have to establish operating procedures. They must be clearly defined for each stage activities - Direct purchase from raw materials manufactures - Purchase via Head quarters - Reception of local and imported orders - Unpacking, labeling and storage of products - Computerized stock managements - Preparations of an order for delivery - Returns of drugs - Managements of outdated drugs - Safety and cleanliness of premises.
13. Audits:- Audits aim at assessing the activities and organization of the warehouse. Their aim at answering key questions such likes - Have initially set of activities & quality objectives been reached? - Are procedures correctly written respected, reviewed? - Does the warehouse guarantee for safety standards?
-:REFERENCES:-1. Good manufacturing Practices For Pharmaceutics, 1st edition, Sidney H. Willing, 173-175.2. PSF-CI PHARMACEUTICAL GUIDE; How better to manage pharmaceutical warehouses, March 2003, 2-21, 27- 31.3. Quality Assurance of Pharmaceuticals; GMP & Inspection; vol.-2. WHO Publication, Pharma book Syndicate; 28-32.4. SOP GUIDELINES, D.H.Shah, business Horizons, Pharmaceutical Publishers, 2nd reprint edition, 2004, 410.