NFNF4712 Farmasi Industri Logistics & Warehouse Inventory Management PDF 2025

NFNF4712 Farmasi Industri Logistics & Warehouse Stock and Inventory Management 06 Jan 2025 Lecture Outcomes: Logistics & Warehouse Explain the key principles of logistics and warehousing in the pharmaceutical industry, focusing on supply chain efficiency and storage req...

NFNF4712 Farmasi Industri Logistics & Warehouse Stock and Inventory Management 06 Jan 2025 Lecture Outcomes: Logistics & Warehouse Explain the key principles of logistics and warehousing in the pharmaceutical industry, focusing on supply chain efficiency and storage requirements. Explain strategies for effective distribution management to ensure timely delivery of pharmaceutical products while maintaining product integrity and compliance. Explain the regulatory guidelines and quality standards on logistics, warehousing, and distribution processes in the pharmaceutical sector. Stock and Inventory Management Explain the principles and techniques of inventory and stock management in the pharmaceutical industry. Explain how to optimize inventory to ensure product availability, reduce waste, and maintain regulatory compliance. Logistics Malaysia Laws on Poisons and Sale of Drugs Dangerous Drugs Act 1952 and Regulations Poison Act 1952 & Regulations Sale of Drugs Act 1952 Control of Drugs and Cosmetics Regulations 1984 Registration of Pharmacist Act 1951 Medicines (Advertisement and Sale) Act 1956 & Regulations Regulatory guidelines and quality standards Logistics Directive and Circulars Date: 01 Jan 2012 Directive: Pematuhan Terhadap Keperluan Garis Panduan Amalan Pengedaran Baik Every local manufacturer /importer/ wholesaler need to comply with GDP requirements Regulatory guidelines and quality standards Logistics GDP Compliance Overview Regulatory guidelines and quality standards Logistics GDP in Malaysia Regulatory guidelines and quality standards Logistics Overview of GDP 3rd Edition 2018 Definition of GDP “The measures that need to be considered in the storage, transportation and distribution of any registered product/cosmetic and its related materials such that the nature and quality intended is preserved when it reaches the consumer.” What does the guideline emphasize on? ….. the appropriate principles for those involved in the supply chain in conducting their activities while ensuring the maintenance of high standards of quality assurance and integrity of the distribution process Regulatory guidelines and quality standards Logistics Overview of GDP 3rd Edition 2018 Premises & Personnel Equipment Stock Handling & Quality Stock Control System Transportation Annex 1: TTSP Good Distribution Practices Complaints Documentation & Records Recalls Self- Inspection Substandard & Falsified Outsourced Products Activities Regulatory guidelines and quality standards Logistics GDP is applicable to.... All organization and individuals involved in any aspect of the storage and distribution. Manufacturers Importers and exporters Wholesalers Third-party providers and freight forwarders Pharmacies Healthcare professionals storing products prior to dispensing or administering to patients Regulatory guidelines and quality standards Logistics Regulatory guidelines and quality standards Logistics GDP Overview Product quality and integrity Product safety Store in the right storage conditions, including during transportation Avoid cross-contamination Right product for the right addressee Regulatory guidelines and quality standards Logistics Compliance Issues Unauthorized Resale of Temperature Control Failure Supply Chain Disruption Fake & Counterfeit Products Pharmaceuticals Regulatory guidelines and quality standards  Logistics Transportation and Storage of the products distribution of the products Regulatory guidelines and quality standards Logistics Regulatory requirements Qualification of Suppliers Obtain supplies from authorized suppliers Qualification and approval of suppliers should be performed prior to purchase Carry out ‘due diligence’ checks Regulatory guidelines and quality standards Logistics Regulatory requirements Qualification of Customers Supply medicinal products to authorized purchasers/parties Checks and periodic rechecks Monitor transactions and investigate any irregularities - risk of diversion and report to competent authority where necessary Regulatory guidelines and quality standards  Logistics & Warehousing Storage Area 01 Segregation, sufficient capacity Security 02 Access control, lock & key 03 License License Hygiene & Cleanliness 04 Cleaning, pest control, prohibited items, defined area Environment Control 05 Temperature, humidity Equipment 06 PPM, calibration Computerized System 07 Back-up, CSV Logistics & Warehousing Design, layout Constructed to ensure the required storage conditions are maintained Secure, structurally sound and of sufficient capacity Well lit and well ventilated Storage Area Segregation Medicinal products (poison) to be kept in segregated areas Adequate storage areas to allow storage of various categories of products i.e. quarantined, approved, rejected, recalled, returned The receiving and dispatched areas should be appropriately designed Special Handling Products with specific storage requirements should be handled and stored according to the specified instructions/requirements i.e. dangerous drugs, psychotropics, cold chain / TTSP etc Supply chain efficiency & storage requirement Logistics & Warehousing Access Control Unauthorized access should be prevented Sufficient controls/measures should be in place i.e. intruder alarm system, CCTV Visitors should be accompanied Security Lock & Key POISON Scheduled poisons, dangerous drugs and psychotropic substances shall be kept according to the requirements under the regulations Supply chain efficiency & storage requirement Logistics & Warehousing License Relevant licenses/approval must be available - approved by local authority A written contract should be in place if premises are not directly operated by the company License Supply chain efficiency & storage requirement Logistics & Warehousing Cleaning Hygiene & Cleanliness Clean and free from accumulated waste or dust Cleaning procedures and records should be established and maintained Pallets in use should be well maintained Pest Control Plan and conduct pest control programme and maintain appropriate records Designed to prevent entry of insects, rodents and other pests/animals Prohibited Items / Defined Area Food, drinks, smoking materials or medicinal products for personal use are prohibited in the storage areas Rest, wash and refreshment rooms should be adequately separated from the storage area Supply chain efficiency & storage requirement Logistics & Warehousing Environment Control Temperature & Humidity Storage conditions must be in compliance with the instruction on the label Controlled storage conditions should be monitored as precautions against deterioration i.e. temperature, light, humidity and cleanliness 9 Temperature mapping should be conducted on the storage areas Monitoring devices should be positioned to continuously monitor the storage conditions Positioning of monitoring devices should be based on the mapping results Alarm system should be available and tested hot / cold spaces to ensure potential Supply chain efficiency & storage requirement Logistics & Warehousing Planned Preventive Maintenance Planned maintenance for all key equipment impacting on storage and distribution should in place Adequate records of repair, maintenance for key equipment should be made and retained Equipment Calibration Equipment used to control or monitor the environment should be calibrated at regular intervals Calibration record should be traceable and retained Supply chain efficiency & storage requirement Logistics & Warehousing Computerized System Computerized Systems System in use must be validated, verified that it is capable of producing the desired results accurately, consistently and reproducibly System description User access / authorization System security Back up - at regular intervals Supply chain efficiency & storage requirement  Distribution Containers, packaging, labelling 01 Containers, packaging, labelling, TTSP Transportation 02 Criteria, mode of transportation, route profiling Handling of Deviation 03 Deviation, temperature excursion Distribution Containers, Packaging Containers & Packaging In line with storage and transportation requirements of the products Packaging materials must not affect the quality and integrity of the products Adequate space and able to protect the products from damage/shock and Labelling Qualified packaging / validated shipping containers Labelling Labels must provide sufficient information on handling and storage requirements Labels used must be sustainable i.e. does not peel off in cold temperature Distribution & delivery Distribution Containers, Packaging Time and temperature sensitive products (TTSP) Qualified equipment (active or passive system) temperature-controlled containers, temperature-controlled vehicles and Labelling Distribution & delivery Distribution Time and temperature sensitive products (TTSP) Containers, Packaging Equip with temperature monitoring equipment during transport i.e. data logger, ccm and Labelling Distribution & delivery Distribution Transport or vehicle used: Transportation Protect against Ensure temperature Suitable for use, Be of sufficient Clean, free from spillage, breakage, conditions are appropriately capacity to allow accumulated waste adulteration, maintained within equipped to protect orderly storage and pests misappropriation and acceptable limits stability and integrity, theft to prevent contamination Distribution & delivery Distribution Mode of Transportation Regardless of the mode of transport, it should be possible to demonstrate that the products have not been exposed to conditions that may compromise their quality and Transportation integrity Route Profiling Perform a risk assessment to identify and quantify risks to products Multiple variables will affect the conditions a shipment may encounter i.e. weather Distribution & delivery Distribution Handling of Deviation Deviation Temperature excursion or product damage should be reported to the distributor A procedure should be in place for investigating and handling temperature excursions Distribution & delivery  Stock and Inventory Management Receiving 01 Arrival check, released/approved/rejected status Stock Rotation and Control 02 Stock count, FIFO/FEFO, shelf life, damaged stock, repacking Returned and Rejected 03 Segregation, assessment, records Distribution 04 Pick and pack, traceability, import and export Disposal 05 Segregation, records Stock & Inventory Management The purpose of the receiving function is to ensure that the arriving consignment is correct, that the medicinal products originate from approved suppliers and that they have not been visibly damaged during transport. Products requiring special handling, storage or security measures should be Receiving prioritized immediately transfer to appropriate storage facilities. poisons, psychotropic substances and dangerous drugs and time and temperature sensitive products (TTSP) Once appropriate checks have been conducted they should be immediately transferred to appropriate storage facilities. Products should be physically inspected and verified against the relevant documentation i.e. Delivery Order, Certificate of Analysis (CoA) and Material Safety Data Sheet (MSDS) (where applicable). Stock & Inventory Management Batches of medicinal products should not be transferred to saleable stock (remain in quarantine status) until a given written release/rejected statement is issued by the authorized personnel. Receiving If a falsified product is suspected, the batch should be segregated and reported to competent authorities as required by national legislation. Stock & Inventory Management Receiving Stock & Inventory Management Periodic stock reconciliation should be performed comparing the actual and recorded Stock Rotation and products quantity. All significant stock discrepancies should be subjected to investigation to check against inadvertent mix-ups and wrong issues of stock. Issues should normally observe the principle of stock rotation (FIFO/FEFO) Control especially where expiry dated products are concerned. All stocks should be checked regularly for expired products. All due precautions should be observed to preclude issuance of expired products. Stock & Inventory Management Stock Rotation and Products with broken seals, damaged packaging or suspected of possible contamination must not be sold or supplied. Control Repacking (including relabelling) of products must be carried out only by company who hold an appropriate licence or approval from authority, unless the activities are exempted from these requirements. Stock & Inventory Management All returned and rejected products should be placed in quarantine and be clearly marked as such. They should be stored separately in restricted area. Returned and The fate of returned and rejected products should be determined after sufficient evaluation by trained and competent person authorised to do so. Rejected All action taken should be approved and recorded. Stock & Inventory Management Records of returned products should be maintained. For each return, documentation should include: Name and address of the consignee returning the products Name or designation of products, batch number and quantity returned Returned and Reasons for return Rejected Use or disposal of the returned products/cosmetics and record of the assessment performed Distribution Controls should be in place to ensure the correct product is picked. The product should have an appropriate remaining shelf life when it is picked. Distribution A system should be in place by which the distribution of each batch of products can be readily identified to permit its recall - traceability. For all suppliers, a document (e.g. Delivery Order) must be enclosed stating the date, name of products, batch number, quantity supplied, name and address of supplier, name and delivery address of the consignee (actual physical storage premises, if different) and applicable transport and storage conditions. Distribution Import and export activities should be conducted in accordance with national legislation and with Distribution international guidelines or standards when appropriate. Distribution Products intended for destruction should be appropriately identified, segregated accordingly and handled in accordance with written procedure. Destruction of products should be carried out in accordance with the national legislative and regulatory requirements and with due consideration to protect the Disposal environment. Disposal records should be maintained for a defined period.  Different understanding on GDP requirement among industry players. Challenges Commitment from all parties involved in the distribution process including the external parties. Handling various type of products (pharmaceutical, medical devices etc) - need to adhere to different guideline / standard imposed by different agencies. Challenging route / lanes (geographical restriction).  Thank You January 2025