Cara Distribusi Obat yang Baik (CDOB)

Summary

This video provides an in-depth explanation of Good Distribution Practices (GDP) for pharmaceutical products, focusing on the key steps involved in ensuring safe, efficient, and high-quality drug distribution. It covers aspects such as proper storage, transportation, documentation, and personnel qualifications. Key regulations, including guidelines for pharmaceutical wholesalers (PBF) and cold-chain product handling, are discussed. The video emphasizes the importance of compliance with national standards to maintain drug safety, quality, and efficacy, ensuring that pharmaceutical products meet all regulatory requirements throughout their distribution lifecycle.

Takeaways

• 😀 Distribution involves activities like procurement, purchasing, storage, and delivery of drugs and pharmaceutical materials.
• 😀 A pharmaceutical distributor (PBF) is a legal entity licensed to handle large quantities of drugs and materials, regulated by the Ministry of Health's regulations.
• 😀 Good distribution practices (GDP) ensure drug quality, safety, and efficacy during storage and transport.
• 😀 The key elements of GDP include quality management, clear responsibility division, training, and maintaining proper documentation.
• 😀 Qualified personnel, particularly pharmacists, are required to manage and oversee the distribution of drugs and materials.
• 😀 Facilities must be designed to prevent contamination or damage, with proper storage conditions (temperature, humidity) and pest control in place.
• 😀 Suppliers and customers must be properly qualified, and proper documentation (such as invoices and purchase orders) must be maintained for all transactions.
• 😀 Self-inspections are critical for ensuring compliance with GDP and identifying areas for improvement.
• 😀 Special handling procedures are required for sensitive drugs, such as narcotics, psychotropic substances, and cold-chain products.
• 😀 Documentation is vital for tracking every step in the distribution process, and must be kept for at least three years.
• 😀 Drugs and materials must be properly managed throughout their life cycle, including quality control, returns, withdrawals, and destruction if necessary.

Q & A

What is the definition of distribution in the context of pharmaceutical products?

Distribution refers to activities that involve procurement, purchasing, storage, delivery, import, and export of medicines and pharmaceutical ingredients, excluding the direct delivery of medicine to patients.

What are distribution facilities, and can you provide an example?

Distribution facilities are locations or organizations used to distribute or deliver pharmaceutical products. An example is a pharmaceutical wholesaler (PBF), which is a company licensed to procure, store, and distribute medicines and pharmaceutical ingredients in large quantities.

How long is the licensing period for a central PBF, and how can it be renewed?

The license for a central PBF is valid for five years and can be renewed. The renewal process must comply with the regulations set by the Ministry of Health.

What is a CDOB certificate, and why is it important?

A CDOB (Good Distribution Practice for Medicines) certificate proves that a PBF or distribution facility meets the required standards for ensuring the quality of medicines or pharmaceutical ingredients during distribution. It includes 12 essential aspects of quality management.

What is the role of quality management in the distribution of medicines?

Quality management ensures that all stages of the pharmaceutical distribution process meet predefined standards, including procurement, storage, delivery, and risk management to prevent and correct quality issues.

Why is proper building design and equipment crucial in pharmaceutical distribution?

The design of buildings and equipment must ensure that medicines and pharmaceutical ingredients are stored under optimal conditions, free from contamination (e.g., dust, pests) and maintained at the required temperature and humidity levels.

What is the role of personnel training in pharmaceutical distribution?

Personnel must be trained in proper handling, storage, and safety procedures for medicines and pharmaceutical ingredients. Training should be documented and evaluated periodically to ensure compliance with Good Distribution Practice (CDOB).

How should pharmaceutical products be handled if they are returned, suspected to be counterfeit, or recalled?

Returned products must be segregated and documented. Counterfeit products should be quarantined and reported to authorities. Recalled products must be separated and tracked, with progress documented until the issue is resolved.

What are the guidelines for transporting pharmaceutical products?

Transportation should be carefully planned with consideration of risk factors to prevent any compromise in product quality. Proper documentation must accompany all shipments, and personnel must follow established procedures to ensure safe and compliant transport.

What are the specific requirements for the storage and handling of narcotics, psychotropics, and precursor drugs?

Narcotics, psychotropics, and precursor drugs must be ordered through special purchase orders signed by a licensed pharmacist. These products must be stored in secure locations with dual locks, and destruction must be witnessed by health authorities.