Pelaksanaan Prosedur CDOB di Perusahaan Distributor Obat | Pedagang Besar Farmasi (PBF)

Summary

In this presentation, Desy Cynthia, a student from Riau College of Pharmaceutical Sciences, discusses the implementation of Good Drug Distribution Practices (CDOB) in a pharmaceutical wholesaler (PBF). She covers the regulatory framework, key aspects of CDOB, including quality management, personnel, facilities, operations, self-inspections, and handling of drug complaints and returns. The presentation also addresses the distribution of narcotics and psychotropics, as well as handling cold chain products. Emphasizing the importance of compliance, she outlines procedures for ensuring drug quality, safety, and effective transportation, all aimed at maintaining drug integrity across the distribution process.

Takeaways

• 😀 A pharmaceutical wholesaler (PBF) must comply with Good Drug Distribution (CDOB) regulations to ensure safe, effective, and quality drug distribution.
• 😀 CDOB regulations are governed by multiple laws, including the Minister of Health Regulations and the Head of POM Agency's guidelines.
• 😀 PBFs are responsible for the procurement, storage, and distribution of drugs, and must adhere to quality management principles to maintain drug integrity.
• 😀 Clear organizational structure and qualified personnel are essential for PBF operations, with specific roles and responsibilities outlined in the regulatory framework.
• 😀 PBF facilities must meet stringent requirements, including proper storage conditions, pest control, and environmental management.
• 😀 Cold chain products (CCPs) must be stored and transported at controlled temperatures (2-8°C for refrigeration, -25°C to -15°C for freezing) to maintain their quality.
• 😀 PBFs are required to document all activities, ensuring traceability and compliance with CDOB standards. Records must be retained for at least 3 years.
• 😀 Periodic self-inspections must be conducted to ensure PBFs remain compliant with CDOB regulations, and corrective actions should be taken for any deviations.
• 😀 Complaints about counterfeit drugs must be investigated, and proper procedures should be followed for returns, recalls, and reporting to authorities.
• 😀 Special categories of drugs, such as narcotics and psychotropics, require additional legal and regulatory compliance, including monthly distribution reports.
• 😀 PBFs must adhere to legal and regulatory requirements for narcotics and psychotropic drugs, ensuring controlled distribution and reporting in accordance with the law.

Q & A

What is a pharmaceutical wholesaler (PBF)?

A pharmaceutical wholesaler (PBF) is a company legally authorized to procure, store, and distribute drugs or medicinal ingredients in large quantities, in accordance with applicable regulations.

What are the main regulations governing pharmaceutical wholesalers in Indonesia?

The main regulations are the Minister of Health Regulation No. 11/48 of 2011, the Minister of Health Regulation No. 34 of 2014 (amendment), the Minister of Health Regulation No. 30 of 2017 (second amendment), and the Regulation of the Head of the POM Agency (2012) regarding technical guidelines for good drug distribution methods (CDOB).

What does CDOB stand for, and what is its purpose?

CDOB stands for 'Good Drug Distribution Methods.' Its purpose is to ensure that drugs maintain their quality throughout the distribution process, adhering to specified requirements and standards.

What are the key aspects of CDOB?

The key aspects of CDOB include quality management, management and personnel, buildings and facilities, operations, self-inspection, handling complaints and returns, transportation, contracts, and documentation.

What does quality management in CDOB entail?

Quality management involves ensuring that drugs are obtained, stored, and distributed according to CDOB requirements, monitoring drug quality, conducting risk assessments, and ensuring compliance through documentation of all related activities.

What role does personnel play in CDOB compliance?

Personnel must be properly trained and qualified according to CDOB standards. There should be a clear organizational structure, regulations to prevent conflicts of interest, and competent personnel responsible for carrying out the procedures.

Why is building and equipment management important in a PBF?

Building and equipment management ensures that the storage areas meet safety, environmental, and security standards, and that drugs are stored at the correct temperature and humidity. It also includes maintaining vital equipment like thermohygrometers and generators.

How should cold chain products (CCP) be handled in a PBF?

Cold chain products must be stored in temperature-controlled environments, such as refrigerators or freezers. Personnel involved in handling these products should receive regular training, and the area where these products are handled should be near the controlled storage space.

What are the specific requirements for handling narcotics and psychotropics in a PBF?

Narcotics and psychotropics must be stored and distributed in compliance with relevant legal requirements. The PBF must submit monthly distribution reports and ensure that these substances are handled according to strict regulatory guidelines.

What is the importance of self-inspection in CDOB compliance?

Self-inspection ensures that all aspects of CDOB are being followed. It is a comprehensive check carried out periodically to verify compliance with laws, regulations, and internal procedures, with reports documenting any deviations and corrective actions taken.

How are complaints and returns handled in a PBF?

Complaints and returns, especially for suspected fake drugs, must be handled according to written procedures. The PBF must investigate any issues, document the process, and report the findings to the authorities, ensuring that returned drugs are properly managed and do not re-enter the market.