FI Inventory

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Questions and Answers

Who is required to adhere to Good Distribution Practices (GDP)?

All organizations and individuals involved in storage and distribution (correct)

Only manufacturers of pharmaceuticals

Only regulatory authorities

Only transportation personnel

Which of the following is NOT a part of maintaining high standards in the distribution process?

Substandard products (correct)

Documentation & records

Transportation management

Quality assurance

What does the term 'self-inspection' refer to in the context of supply chain activities?

Inspection carried out by external bodies

Internal assessment of compliance with quality standards (correct)

Random checks by regulatory authorities

Customer feedback on products

Which element is related to proper handling within the GDP framework?

Quality system implementation Signup and view all the answers

What is a critical factor for ensuring the integrity of the distribution process?

Adhering to regulatory guidelines and quality standards Signup and view all the answers

Which of the following practices helps mitigate the risk of falsified products?

Comprehensive documentation and record-keeping Signup and view all the answers

What role does stock control play in good distribution practices?

It manages inventory freshness and reduces waste. Signup and view all the answers

Which document is essential for addressing and managing complaints within the supply chain?

Complaint management log Signup and view all the answers

What should be done if there is a temperature excursion during distribution?

Report it to the distributor Signup and view all the answers

Which of the following best describes the purpose of the receiving function?

To verify that products originate from approved suppliers Signup and view all the answers

What management strategy ensures products are used before their expiration dates?

FIFO (First In, First Out) Signup and view all the answers

What is NOT required to be done before products can be transferred to saleable stock?

Immediately transfer to market Signup and view all the answers

What should be done with returned or rejected products?

Segregate, assess, and record them Signup and view all the answers

How should products that require special handling be prioritized during receiving?

They should be immediately transferred to appropriate storage facilities Signup and view all the answers

What is involved in the disposal of products in inventory management?

Segregation and documentation Signup and view all the answers

What documentation might be required to verify products upon receiving?

Delivery Order and Certificate of Analysis Signup and view all the answers

What is the main focus of logistics and warehousing in the pharmaceutical industry?

Ensuring supply chain efficiency and meeting storage requirements Signup and view all the answers

Which act regulates the sale of drugs in Malaysia?

Sale of Drugs Act 1952 Signup and view all the answers

What is one objective of effective distribution management in pharmaceuticals?

Maintaining product integrity and compliance during delivery Signup and view all the answers

What is one principle of stock and inventory management in the pharmaceutical sector?

Regularly updating stock levels to reduce waste Signup and view all the answers

What is emphasized in the guideline of Good Distribution Practice (GDP)?

Preserving the nature and quality of products during storage and distribution Signup and view all the answers

Which of the following is NOT a regulation affecting pharmacological practices in Malaysia?

Peatland Management Act 1999 Signup and view all the answers

What is a primary requirement for local manufacturers and wholesalers in Malaysia concerning GDP?

To comply with Good Distribution Practice guidelines Signup and view all the answers

What aspect of inventory optimization is crucial for pharmaceutical companies?

Ensuring product availability while minimizing waste Signup and view all the answers

What is the primary purpose of temperature mapping in storage areas?

To optimize supply chain efficiency & storage requirements Signup and view all the answers

What should be retained as part of the planned preventive maintenance protocol?

Records of repair and maintenance for key equipment Signup and view all the answers

When should equipment used to monitor the environment be calibrated?

At regular intervals Signup and view all the answers

Which of the following is a requirement for computerized systems used in storage and distribution?

They must be validated and verified for accuracy Signup and view all the answers

What is true regarding packaging and labeling in storage and distribution?

Packaging materials must protect products from damage Signup and view all the answers

Which factor is crucial for the positioning of monitoring devices in storage areas?

Results from temperature mapping Signup and view all the answers

What is an important aspect of the labeling requirements for products?

Labels must provide adequate storage and handling information Signup and view all the answers

What aspect of supply chain efficiency is influenced by the calibration of monitoring equipment?

The consistency of environmental control Signup and view all the answers

What should be tested to ensure effectiveness in monitoring storage conditions?

The alarm systems in place Signup and view all the answers

What is a key component necessary for containers used in distribution?

Containers must provide adequate protection against damage Signup and view all the answers

What should be done if a falsified product is suspected?

The batch should be segregated and reported. Signup and view all the answers

What principle should be observed when issuing stock, especially for expiry dated products?

First In, First Out (FIFO) Signup and view all the answers

How should products with broken seals or damaged packaging be handled?

They must not be sold or supplied. Signup and view all the answers

What is required for the repacking of products?

An appropriate license or approval is needed. Signup and view all the answers

What should happen to returned and rejected products?

They should be put in quarantine and marked. Signup and view all the answers

Who should determine the fate of returned and rejected products?

Trained and competent personnel authorized to do so. Signup and view all the answers

What should be done if there is a significant stock discrepancy?

Investigate against inadvertent mix-ups. Signup and view all the answers

What records should be maintained regarding returned products?

Records of returned products must be maintained. Signup and view all the answers

What information must be included in the documentation for returned products?

Name and address of the consignee returning the products Signup and view all the answers

Which of the following is a required element in the distribution control process?

Having a system for product recall traceability Signup and view all the answers

For returned products intended for destruction, what should be ensured?

They should be appropriately identified and segregated Signup and view all the answers

What is necessary for import and export activities according to the guidelines?

Conducting activities in accordance with national legislation Signup and view all the answers

What challenge is mentioned regarding Good Distribution Practice (GDP) requirements?

Different understanding of GDP among industry players Signup and view all the answers

What should be done with products intended for destruction?

Disposed of with consideration to environmental safety Signup and view all the answers

When picking products for distribution, what is crucial to verify?

Products should have an appropriate remaining shelf life Signup and view all the answers

What documentation is required to accompany all suppliers in distribution?

A delivery order containing specific details Signup and view all the answers

Study Notes

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.

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