Cara Distribusi Obat yang Baik (CDOB) 2020

Summary

The script outlines the key principles of CDOB (Good Distribution Practices for Pharmaceuticals) as per BPOM regulations. It covers various aspects of pharmaceutical distribution, including quality management, personnel responsibilities, facility maintenance, and equipment calibration. The document highlights the importance of supplier qualifications, storage, packaging, and transportation to maintain drug integrity. It also discusses the handling of complaints, returns, and recalls, ensuring compliance with safety and regulatory standards. Through systematic risk management, regular inspections, and detailed documentation, the CDOB framework ensures the safety, quality, and authenticity of pharmaceutical products throughout the distribution chain.

Takeaways

• 😀 Proper distribution of medicines must comply with BPOM regulations (No. 26 of 2020) to ensure the quality, safety, and efficacy of the drugs.
• 😀 The quality management system (QMS) in the distribution facility should include responsibility for processes, risk management, and regular evaluations of the system.
• 😀 Distribution facilities should have well-organized management structures, and all personnel must be adequately trained and competent, with qualifications verified periodically.
• 😀 Facilities must have clean and adequately structured buildings with separate areas for drug handling, proper pest control, and environmental controls (temperature, humidity).
• 😀 Equipment used in the distribution process should be regularly calibrated, maintained, and fully traceable to ensure drug quality.
• 😀 Computer systems used for distribution must be validated, secure, and capable of maintaining clear and auditable records of transactions.
• 😀 Supplier qualification is crucial, and suppliers should have proper licenses, competence, and a reliable reputation to prevent the circulation of counterfeit medicines.
• 😀 Drug reception must involve checking for physical integrity, expiration dates, and documentation for traceability, including batch numbers.
• 😀 Storage conditions must follow industry recommendations, ensuring drugs are protected from light, temperature fluctuations, and contamination.
• 😀 Any defective or counterfeit drugs identified must be isolated, reported to relevant authorities, and appropriately disposed of, with thorough documentation of actions taken.

Q & A

What is the purpose of the CDOB regulation as mentioned in the script?

The purpose of the CDOB (Good Distribution Practices for Drugs) regulation is to ensure the safety, efficacy, and quality of drugs during their distribution process, in accordance with BPOM regulations.

What are the key elements of quality management in distribution facilities?

The key elements of quality management in distribution facilities include system quality, risk management, and the responsibility of processes, resources, and activities, ensuring that all steps are documented and monitored periodically.

What qualifications are required for personnel handling pharmaceutical distribution?

Personnel must be competent, adequately trained in CDOB aspects, and regularly evaluated to ensure they meet the standards. The responsible person should be a licensed pharmacist.

What are the facility requirements for drug storage and distribution?

The facility must have separate areas for drug status determination, secure access, proper temperature control, pest control, and cleanliness. Storage areas should be distinct from personnel areas to prevent contamination.

How should equipment be managed in drug distribution facilities?

Equipment must be maintained according to a scheduled program, calibrated accurately, and undergo regular checks to ensure they do not affect drug quality. Maintenance activities should be thoroughly documented.

What role does risk management play in quality management for drug distribution?

Risk management involves identifying, handling, and documenting potential risks related to the distribution process. It includes corrective actions and preventive measures to maintain the integrity of the drug supply chain.

What procedures are in place for handling complaints about drugs or distribution processes?

Complaints related to drug quality or distribution must be investigated thoroughly, documented, and classified according to their nature. Trend analysis and corrective actions are essential to address recurring issues.

How are returned drugs or materials managed in the distribution process?

Returned drugs must be examined to ensure they meet quality standards, properly documented, and stored securely. Drugs that are counterfeit or suspected of being fake must be quarantined and reported to the relevant authorities.

What is the process for handling drug withdrawals from the market?

Drug withdrawals should be executed promptly once notified by BPOM or the industry. Affected drugs must be quarantined, clearly labeled, and recorded. The process should ensure proper documentation and reconciliation of quantities.

What are the regulations for handling drugs that are near expiration or have expired?

Expired or near-expired drugs must be handled carefully according to industry guidelines. Such drugs should not be distributed or used and must be disposed of properly to maintain the integrity of the drug supply chain.