OUR LADY OF FATIMA UNIVERSITY COLLEGE OF PHARMACY Good Storage Practices MODULE 3, Part 1 Experiential Pharmacy Practice in Institutional Pharmacy INPI 411 CHECKLIST: ü ü ü ü ü ü ü Attend Online Lecture via Zoom Meeting Duration: 3 hours Read course and unit outcomes. Read study guide prior to online attendance. Read required learning resources Proactively participate in online discussions Answer and submit course unit tasks LEARNING OUTCOMES: At the end of this unit, the students are expected to: 1. Determine the considerations in organization and management of a pharmacy 2. Discuss the guidelines in Good Storage practices 3. Demonstrate competence in receiving of deliveries, display and storage of pharmaceutical products. OUTLINE: ü Definition of terms ü Sources of Guidelines on Good Storage Practices ü Principles in receiving of deliveries, display and storage of pharmaceutical products (using the Guidelines for the Good Storage Practice of Essential Medicines and other Health Products by Department of Drugs and Food (Cambodia)) Definition of Terms Storage – the storing of pharmaceutical products up to the point of use Good storage practices – a part of quality assurance that ensures that the quality of pharmaceutical products is maintained by means of adequate control throughout the storage thereof First-in/first-out – a distribution procedure to ensure that the oldest stock is distributed first and/or used before a newer identical stock item is distributed and/or used First to expire/first out - a distribution procedure to ensure that the stock with the earliest expiry date is distributed first and/or used before an identical stock item is distributed and/or used Sources of Guidelines Annex 9 Guide to good storage practices for pharmaceuticals by WHO Administrative Order no. 2013 – 0027 – Adoption and Implementation of WHO Annex 5 Guide to Good Distribution Practices (GDP) and Annex 9 Guide to Good Storage Practices of Pharmaceuticals USP <1079> Good Storage and Distribution Practices MSF medical guidelines (Medecins Sans Frontieres) Guidelines for the Storage of Essential Medicines and Other Health Products by the Ministry of Health, Kingdom of Cambodia Storage is an important activity in the medicines supply chain management. Good Storage Practices assist in ensuring the quality, safety and identity of pharmaceutical products throughout the whole supply management cycle up to their point of use Good Storage Practices **Refer to Guidelines for the Storage of Essential Medicines and Other Health Products General Requirements: • There should be an adequate number of qualified personnel to achieve pharmaceutical quality assurance objectives. • Storage areas should be designed or adapted to ensure good storage conditions. - Sufficient area that allows orderly storage of various supplies/products (including the returned, rejected or recalled items) preventing mix ups or cross contamination - Maintained clean and dry and with temperatures meeting the required condition by the products (this is monitored daily temp and RH) based on stability testing - Materials should be off the floor using pallets ( pallets should be clean and in good condition) Good Storage Practices **Refer to Guidelines for the Storage of Essential Medicines and Other Health Products General Requirements: • Storage areas should be designed or adapted to ensure good storage conditions. - It should be free from waste and vermin. (there is a written sanitation program, safe pest control program( no risk of contamination) - Facilities should have controls that mitigate risks of fire, water or explosion - There should be areas for the different processes (reception areas for receiving materials sufficient in size to allow cleaning if needed) - Areas are clearly identified: rejected, expired, recalled or returned materials or products and separated physically. Also identified are areas for hazardous, high value materials, narcotics – ensure not only safety but also security Good Storage Practices Routine Management or Storeroom Management Tasks - Cleaning, monitoring of storage condition, adherence to SOPs and proper documentation KEEPING YOUR STORE CLEAN AND TIDY MAKES MANAGING YOUR MEDICINES AND HEALTH PRODUCTS EASIER! I. Receiving and Arranging Commodities 1. Receiving Health Commodities 2. Arranging Commodities 3. Stock Rotation 4. Orderly Arrangement of Essential Medicines Receiving the items • There should be sufficient space to receive the products • Sufficient space to perform accurate inspection of items • Good lighting to allow accurate inspection Arranging Commodities • Use pallets in stacking cartons • Observe the label’s storage condition • Secure high value products Arranging Commodities • Stacking of cartons in pallets • Securing high value items Check inventory records for stock on hand. Then, conduct a physical inventory (physically count the quantities on hand) and compare the results Arranging Commodities Common terms • Store frozen • Store in cold place • Keep cool • Store at room temperature • -10 to -20˚C • 2˚- 8˚C • 8˚-15˚C • 15˚-25˚C (up to 30˚C) Arranging Commodities Meaning of storage conditions indicated on the label : “Do not store over 30 °C” from +2 °C to +30 °C “Do not store over 25 °C” from +2 °C to +25 °C “Do not store over 15 °C” from +2 °C to +15 °C “Do not store over 8 °C” from +2 °C to +8 °C “Do not store below 8 °C” from +8 °C to +25 °C “Protect from moisture” “Protect from light” storing in light resistant container Stock Rotation • Follow the FEFO policy • place the nearly expiring items in front • Mark the packages as indicate Exp Dates in the Stock card • Perform periodic stock reconciliation (actual from recorded) • Perform physical inspection (damaged, to many opened packages) • Follow an orderly arrangement of stocks Arrangement of Medicines • Some common systems of arranging medicines: • Alphabetical order by generic name or INN • Therapeutic or pharmacological category • Dosage form/ Route of administration • Frequency of use • Commodity coding • Mixed Ex. – oral drugs – injectable drugs – infusion fluids – vaccines, immunoglobulins and antisera – drugs for external use and antiseptics – disinfectants Arrange alphabetically Arrangement of Medicines • Commodity Coding • Use of SKUs (Stock Keeping Unit) • A stock-keeping unit (SKU) is a scannable bar code composed of an alphanumeric combination of eight-or-so characters. • The characters are a code that track the price, product details, and the manufacturer • Primarily use to facilitate inventory Good Storage Practices II. Keeping Track of Products in Your Storeroom 1. Standard List of Stock Items 2. Stock Card 3. Physical Inventory 1. Standard List of Items • A master list of stock items that includes all products they handle, with their details (form, strength and quantity per package) • The list should be updated and made available for reference • Inventory records should be maintained for all products on the list Keeping Track of Products 2. Use of Stack Cards Stock cards may contain the following: product name/description (including the form [ e.g. capsule, tablet, liquid suspension, etc.] and strength) – stock on hand/beginning stock balance – receipts – issues – losses/adjustments – closing/ending balance – transaction reference special storage conditions ( e.g. 2◦C - 8◦C), unit prices, lot numbers/bin locations, tem codes, expiry dates Keeping Track of Products • Stock cards are useful to provide information about consumption, lead times for requisition, maximum and minimum stock levels, emergency order point • Observe accurate and proper documentation • Comprehensive records should be maintained showing all receipts and issues of materials and pharmaceutical products according to a specified system, e.g. by batch number. Terms used: • Lead time- the amount of time between when a purchase order is placed to replenish products and when the order is received in the • Minimum stock level - smallest quantity of a particular item of material that must be kept at all times. Reorder point. • Maximum stock level – the amount not to be exceeded • Emergency order point - The level of stock that triggers an emergency order, regardless of the timing within the review period. It is always lower than the min. Keeping Track of Products 3. Physical Inventory There are two kinds of physical inventory: Complete physical inventory: all products are counted as the same time. A complete inventory should be taken at least once a year. Cyclic or random physical inventory: Selected products are • counted and checked against the stock keeping records on a rotating or • regular basis throughout the year. - Also called cycle counting. - Ex. In Drugstores: conducted by location, at the time the personnel is available, Update the stock keeping records Take action based on the result of the physical inventory Good Storage Practices Handling returned good in the Store: Returned goods and product recall Returned or rejected goods including recalled goods, should be handled in accordance with approved procedures and records should be maintained. All returned goods should be placed in quarantine and returned to saleable stock only after this has been approved by a nominated, responsible person following a satisfactory quality re-evaluation. Product recall: There should be a procedure to recall from the market, promptly and effectively, pharmaceutical products and materials known or suspected to be defective. ANY QUESTIONS? REFERENCES: Cambodia-Department of Drugs and Food: Guidelines for the storage of essential medicines and other health products: globi-reg.com/wp-content/uploads/2019/08 USP <1079> Good Storage and Dsitribution Practices: https://pharmacy.ks.gov/docs/librariesprovider10/default-document-library/ups-36-goodstorage-and-shipping-practices.pdf Administrative-Order-No.-2013-0027: https://www.fda.gov.ph/wpcontent/uploads/2021/04/Administrative-Order-No.-2013-0027.pdf WHO Good Storage Practices: https://www.who.int/medicines/areas/quality_safety/quality_assurance/GuideGoodStorageP racticesTRS908Annex9.pdf Organization and management of a pharmacy: https://medicalguidelines.msf.org/viewport/EssDr/english/organization-and-management-ofa-pharmacy-16688159.html THANK YOU FOR LISTENING!
