CONTENTS ¥ Introduction ¥ Types of Warehouses ¥ Characters of Good Warehouse ¥ Good Warehousing Practices Y WHO guidelines of Good Warehousing Practices ¥ Material Management. INTRODUCTION WAREHOUSE - A suitable space is provided to raw material, handling of raw and packaging materials required for manufacturing. This space is known as Warehouse. Different dosage forms must be stored and transported under different environmental conditions and therefore, there cannot be one general rule for their handling. Maintaining proper storage condition for pharmaceutical products is vital to ensure their quality, safety and efficacy. Thus, it is vital to follow Good Warehousing Practices and Good Distribution Practices to ensure the quality of products is maintained.Various areas of warehousing :- Receiving area — include initial inspection, cleaning and weight checking. Sampling area — with adequate facilities to prevent cross contamination Storage area — including specific storage like air condition rooms, cold rooms, hazardous chemical storage room. Rejected materials area Dispensing area Premises must be located, designed, constructed, adapted and maintained to suit the operations to be carried out.CLIMATE CONTROLLED co- EXPORT/IMPORT OPERATIVE a BONDED STORAGE DISTRIBUTION CENTRESPrivate warehouse — operated by a company for shipping, and storing its own products, Owned and managed by manufacturers or traders Public warehouse — provide storage and physical distribution services on rental basis. These are used by small and large firms. Co-operative warehouse — owned, managed, and controlled by co- operative societies. Bonded warehouse — licensed to accept imported goods for storage before payment of customs duty. Distribution centres — designed to move goods, highly automated. Receive goods and efficiently deliver to customers. Cold storage — temperature is controlled here for sensitive products. Export/ Import warehouse — located near ports where international trade is undertaken. These provide storage facilities for goods awaiting onward movements. Climate — controlled warehouse — provide storage of many products which need special handling conditions. Freezers for frozen products, ete.CHARACTERS OF GOOD WAREHOUSE * Convenient location. * Availability of mechanical appliances to load and unload goods. * Properly cleaned. + Latest fire fighting equipments. * Good preservation of drugs and equipments. * 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. + Promote rational use of pharmaceutical products.GOOD WAREHOUSING PRACTICES Guidelines of Good Warehousing Practices include :- . 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 code, and the lots status must be identified — approved, quarantined, and rejected. Written procedures must describe the distribution process for each drug. Written procedures must describe the appropriate storage conditions for each drug Warehouse must ensure that the storage of each drug is in line with its specific requirements defined by the manufacturer, Temperature controlled space requires sophisticated control and monitoring equipment to ensure that the temperature of the facility stays within very specific parameters. Climate controlled space regulates and monitors both the temperature and humidity of the space.WHO GUIDELINES OF GWP The WHO guide to good storage practices for pharmaceuticals highlights the following important areas for warehousing of pharmaceuticals. 1. Personnel 2. Premises and Facilities 3. Storage Requirements 4. Returned Goods 5. Dispatch and Transportation of Goods 6. Product RecallPERSONNEL All sites where pharmaceutical products are stored must have sufficient number of appropriately qualified and trained personnel. Warehouse staff should include — a responsible pharmacist, warehouse keeper, warehouse worker, cleaner, security guard. Staff must be given necessary training on good storage practices, the best practices to adopt and safety issues. They must also be trained on matters of personal hygiene, good sanitation practices, use of working garments and suitable protective clothing. Those employees working in special storage areas must be trained on the regulations, and procedures to be followed.PREMISES AND FACILITIES Entry must be controlled and only authorized persons must be permitted to enter. Area must be sufficient size to allow the systematic storage of different categories of materials. There must be separate areas for products in quarantine, approved products, and products that have been rejected, recalled etc. Temperature and relative humidity should be maintained according to the requirement. There must be provisions to monitor such parameters. All materials should be stored in manner which supports ease of cleaning as well as inspection. Measures should be taken to prevent accumulation of waste, entry of vermin and pest. Agents used for cleaning should be validated.Receiving and dispatch areas should be designed to protect materials from weather conditions. Separate sampling areas must be provided in a controlled environment. Products that are sensitive, dangerous, hazardous, narcotic ete with a risk of fire, explosion, or abuse must be stored in dedicated areas with sufficient security and safety measures. Procedures must be designed to prevent mix-ups, contamination and cross contamination. Damaged items must be immediately removed from the usable stock. Storage of narcotic drugs must comply with international conventions. Rejected materials must be clearly marked and controlled. All areas must be lighted appropriately to allow the safe and accurate performance of all operations.STORAGE REQUIREMENTS Written instructions as well as records must be available to document all activities take place in the storage area. The route taken by the products and information through the organisation must be describe in sufficient details. Each product stored must have permanent information regarding the storage conditions and precautions to be observed. Records must be maintained for every delivery and include the description of goods, quantity, quality, etc. Products must be stored in appropriate containers so that their quality is not affected. Minimum labelling requirements for containers include, name of the material with pharmacopoeial reference, batch number, expiry date, date of re-test and storage conditions.Every incoming material should be checked immediately against the order, then physically verified. Uniformity of containers must also be verified. Every container must be carefully checked for contamination, damaging, or tampering. Sampling should be done and then the goods should be taken to quarantine area Warning signs for — spillage, odours, dirt, tears, scratches, animal faeces. Actual stock must be compared with recorded quantity of stocks Expired or outdated products must be periodically checked and removed. Until such material, precautions must be taken to ensure they are not issued for use.RETURNED GOODS Returned goods, must be handled according to approved procedures. Records of the returned goods should be maintained. Goods that pass a quality re — evaluation, may be returned to stock approved for sale. Any pharmaceutical product returned by patients to the pharmacy must be destroyed. DISPATCH AND TRANSPORTATION OF GOODS This should be done under conditions that ensure the prescribed storage conditions are maintained, and integrity of the product is not affected. When transported, devices must be used to monitor temperature conditions, records of such delivery must be maintained. Records should be contained — dispatch date, customer name, address, product description, quantity, storage conditionsPRODUCT RECALL * Appropriate procedures must be set in place for prompt and effective recalls of known and suspective defective product. * Product recalls can be triggered by any of the following situations :- - customer complaints that draw attention to a critical quality defect. - reports of adverse drug reactions - samples retained for stability studies show deterioration of product quality. Once finished products, reach the warehouse, they are not subjected to any further testing or inspection. Good Warehousing Practices must be followed by adequately trained personnel to make sure that the quality of the product reaching the end user is the same as it was when it left the manufacturing unit,MATERIAL MANAGEMENTINTRODUCTION + Important management tool which will be useful in getting the right quality and right quantity of supplies at right time, having good inventory control and adopting sound methods of condemnation and disposal will improve the efficiency of the organisation. FOUR BASIC NEEDS OF MATERIAL MANAGEMENT * To have adequate materials on hand when needed. * To pay the lowest possible prices, consistent with quality and value requirement for purchase materials * To minimize the inventory investment * To operate efficiently.BASIC PRINCIPLES OF MATERIAL MANAGEMENT * Planning * Organizing * Staffing * Directing * Controlling * Reporting * Budgeting * Sound and effective purchasing system and methods * Must not increase any other costs * Simple inventory control programme ELEMENTS OF MATERIAL MANAGEMENT * Demand estimation * Identify the needed items * Calculate from the trend in consumption during last two years * Review with resource constraintsINVENTORY CONTROL The term Inventory means the value or amount of materials or resource in hand Inventory Control is the process by which inventory is measured and regulated accordingly. Ensures an adequate supply of materials Better utilisation of available stocks Checks against the loss of materialsTYPES OF INVENTORY MODELS * Economic order quantity (EOQ) Always Better Control (ABC) Analysis VED Analysis FSN Analysis. ECONOMIC ORDER QUANTITY EOQ is the technique of ordering materials whenever stock reaches the reorder point. In this technique, the order quantity is larger than a single period’s requirement so that ordering costs and holding costs balance out. EOQ = (average monthly consumption * lead time) + buffer stock — stock on hand Lead time = duration time between placing an order and receipt of materialALWAYS BETTER CONTROL (ABC) ANALYSIS This technique divides inventory into three categories This technique is based on cost criteria ‘A’ items category — smaller in quantity but consume a large amount of financial resources. Managed by the top management and they should have a strict and closer watch. ( 10% materials , 70% cost) ‘B’ items category — intermediate level. Managed by the middle level management and should have moderate safety stocks. (20% materials, 20% cost) ‘C’ items category — larger in quantity but consume a smaller amount of the financial resources. Requires only ordinary control measures (70% materials, 10% cost)VED ANALYSIS Based on critical value and shortage cost of an item Items are classified into — Vital — shortage of products cannot be tolerated. They are stocked adequately to ensure smooth operation. Essential — shortage can be tolerated for a short period. They should be efficiently stocked to ensure regular flow of work Desirable — shortage will not adversely affect, but may be using more resources. They can be easily purchased from the market as and when needed.« ° FSN ANALYSIS FSN :- Fast moving, Slow moving, and Non — Moving Classification is based on the pattern of issues from stores and is useful in controlling obsolescence. The items are usually grouped in periods of 12 months. Helps to avoid investments in non moving or slow items No issues in the time period — N item 10-45 issues in time period — S item Exceeding other limits of issue — F item