FI Inventory

Logistics & Warehouse

• The presentation covers logistics and warehousing specifically in the pharmaceutical industry.
• Key principles of supply chain efficiency and storage requirements are discussed.
• Strategies for effective distribution management, ensuring timely delivery while maintaining product integrity and meeting compliance regulations, are outlined.
• Regulatory guidelines and quality standards for pharmaceutical logistics, warehousing, and distribution processes are explained.

Stock and Inventory Management

• The presentation covers principles and techniques of inventory and stock management in the pharmaceutical industry.
• Methods for product optimization, waste reduction, and regulatory compliance are discussed.
• The process for maintaining appropriate inventory levels are explained, including managing product availability.

Malaysia Laws on Poisons and Sale of Drugs

• Dangerous Drugs Act 1952 and its Regulations are mentioned as a regulatory framework.
• Poison Act of 1952 and Regulations are mentioned.
• Sale of Drugs Act 1952 is listed as a relevant act.
• Drug and Cosmetics Regulations of 1984 are in place.
• Registration of Pharmacist Act of 1951 is mentioned.
• Medicines (Advertisement and Sale) Act 1956 and Regulations are noted.

Directive and Circulars

• A document dated January 1, 2012 outlines compliance requirements for Good Distribution Practices (GDP) for manufacturers, importers, and wholesalers.
• All involved in the production and distribution of pharmaceuticals must comply with GDP requirements.

GDP Compliance Overview

• The overview notes the importance of collaboration between global regulatory agencies including PIC/S, FDA, EMA, and WHO.
• The presentation details compliance with national agencies like the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia.

GDP in Malaysia

• The presentation details the evolution of Good Distribution Practice (GDP) in Malaysia from 1995 to the present.
• Three editions of GDP guidelines are documented.

Overview of GDP 3rd Edition 2018

• The overall aims and purposes of the 3rd Edition of the Good Distribution Practice (GDP) guidelines are explained.
• The guidelines for those involved in the supply chain emphasizes appropriate principles to maintain quality assurance and distribution process integrity.

Overview of GDP 3rd Edition 2018 (Continued)

• This further detail a number of elements of the GDP including personnel, premises & equipment, inventory management, handling and transportation, complaints, recalls and self-inspection.

GDP Applicability

• All organizations and individuals involved in any aspect of storage and distribution, including manufacturers, importers, exporters, wholesalers, third-party providers, pharmacies, and healthcare professionals are covered.

Pharmaceutical Supply Chain

• A visual representation of the pharmaceutical supply chain illustrates the flow from manufacturers to wholesalers, then to pharmacies and eventually to hospitals and patients.

GDP Overview

• Product quality, integrity, product safety, proper storage conditions including transportation, avoidance of contamination, and correct delivery of products to the right recipient are highlighted.

Compliance Issues

• The presentation addresses potential issues such as temperature control failure, supply chain disruption, fake/counterfeit products, unauthorized resale of pharmaceutical products.

Storage of Products

• Includes topics such as product storage.

Transportation of Products

• Presents the means to transport and distribute products.

Regulatory Requirements: Qualification of Suppliers

• The procedures for qualification and approval, due-diligence checks on suppliers, for the supply of pharmaceutical products prior to purchase is laid out.

Regulatory Requirements: Qualification of Customers

• The presentation details the requirements for supplying medicinal products to authorized individuals and checking on them periodically. Regular checks are necessary to prevent irregularities like diversion.

Logistics & Warehousing: Storage Area

• Storage area requirements, including segregation of various product types (poison, quarantine), sufficient capacity, security measures (access control, locks, keys), license requirements, and maintaining hygiene (cleaning, pest control), are discussed.

Logistics & Warehousing: Design, Layout, and Segregation

• The design of the layout of storage areas must accommodate necessary needs for holding products while maintaining appropriate environmental conditions and security.
• Storage areas should be segregated as needed by product type.

Logistics & Warehousing: Security and Access Control

• Detailed requirements for access, preventative measures, and security personnel are detailed.
• There is a necessity for controls to prevent unauthorized access, using devices like CCTV and intruder alarms.

Logistics & Warehousing: License

• The presentation details the type of licenses and contracts required for valid business operations.

Logistics & Warehousing: Hygiene & Cleanliness

• Procedures for cleaning storage areas, maintaining hygiene, conducting pest control, and defining restricted zones inside the storage area are outlined.

Logistics & Warehousing: Environment Control

• Maintaining humidity, temperature, and light levels are important, with monitoring devices.

Logistics & Warehousing: Planned Preventive Maintenance and Calibration

• Maintenance for storage equipment and procedures are included, including regular maintenance and calibration of relevant equipment (and records).

Logistics & Warehousing: Computerized System

• Requirements for validation and verifying computer systems and associated security procedures along with regular updates (backup) are detailed.

Distribution: Containers, Packaging, and Labelling

• Requirements for container, packaging, and labelling, including the specifications for materials, and that packaging must not alter product quality.
• Labelling is essential for providing information about handling and storage.

Distribution: Time and Temperature Sensitive Products (TTSP)

• The guidelines mention the importance of appropriately qualified equipment, including active or passive systems.
• Temperature-controlled containers and vehicles are emphasized for time and temperature sensitive goods and the need for temperature monitoring equipment.

Distribution: Transportation

• The mode of transport should be capable of maintaining product integrity and quality throughout the travel.
• Route profiling and risk assessments are crucial to ensure the best way to transport the goods.
• The need to be vigilant for temperature excursions is vital.
• Procedures that address and deal with any mishaps on the vehicles and products are outlined.

Stock & Inventory Management: Receiving

• Receiving function, product accuracy, checks on incoming products from authorised vendors, required handling procedures for different pharmaceutical products (such as poisons, psychotropics), and immediate product transfer.
• Receiving checks should include physically inspecting products against the relevant documentation.

Stock & Inventory Management: Receiving (continued)

• Batches of products not ready for sale must be placed in quarantine.
• Any suspected falsified products need a prompt inspection and reporting to appropriate authorities.

Stock & Inventory Management: Stock Rotation & Control

• Reconciliation, FIFO/FEFO and expiry date management are important factors for stock rotation.
• Products should be appropriately labelled and handled if repackaged.

Stock & Inventory Management: Returned and Rejected

• Return and reject procedures and documentation rules are vital.
• Recording of returned items is essential for proper handling, procedures, and record-keeping.

Distribution

• Ensuring appropriate products and labels are present and shelf life is appropriate during picking is important.
• Crucial information (like supplier information) should accompany the products.
• Import and export activities must conform to international protocols and guidelines.
• Proper products for destruction are to be appropriately labeled, segregated, and handled according to existing protocols. Disposal products are to be recorded.

Challenges

• Varied understanding of GDP requirements among industry players.
• Maintaining commitment across all supply chain parties.
• Handling various product types needs consistent guideline adherence, and varying standards are mentioned.
• Varied transport lanes and geographical restrictions are also included.