We Talk About Pharmacy Ep. 2 : CDOB (Cara Distribusi Obat yang Baik) Part 1

Summary

This video discusses the best practices in drug distribution, focusing on quality management, organizational structure, personnel, and operational processes. It covers key aspects like ensuring proper facilities, managing suppliers, receiving and storing products, and handling product returns, complaints, and recalls. Emphasis is placed on maintaining drug integrity through quality assurance systems, staff training, and monitoring storage conditions. The script also touches on the legal procedures for handling counterfeit products, managing drug recalls, and ensuring proper transport logistics, with a strong focus on compliance and documentation throughout the distribution process.

Takeaways

• 😀 Ensure quality management throughout the distribution process, with clear responsibilities and risk management strategies in place.
• 😀 Organizational structure must be clear and well-understood, with competent personnel supported by adequate training.
• 😀 Facilities must comply with licensing requirements, have the capacity to store medicines properly, and include necessary monitoring tools like temperature control.
• 😀 Ensure procurement processes are transparent, with suppliers meeting required standards and pharmaceutical qualifications.
• 😀 Reception of pharmaceutical goods must be carefully inspected for quantity, authenticity, and documentation, with all findings documented.
• 😀 Storage conditions should minimize risks such as contamination and mix-ups, with proper labeling and controlled environments for sensitive products.
• 😀 Distribution must match orders and be thoroughly controlled, including ensuring customer qualifications and payment confirmation.
• 😀 Destroy expired or substandard products following legal guidelines and ensure proper documentation and reporting to regulatory authorities.
• 😀 Regular self-inspections should be performed to evaluate compliance with quality standards and correct any found issues in a timely manner.
• 😀 All complaints about medicines, including suspected counterfeits, should be thoroughly investigated, with returned products stored separately and documented appropriately.
• 😀 The recall process must be swift and well-documented, with effective communication with relevant authorities and stakeholders to ensure consumer safety.

Q & A

What is the importance of quality management in pharmaceutical distribution?

Quality management ensures that the integrity of pharmaceuticals is maintained throughout the distribution process. It involves setting up a system to manage risks, monitor processes, and guarantee the product’s quality from supply to delivery.

Why is it essential to have a clear organizational structure in pharmaceutical distribution facilities?

A clear organizational structure ensures that all personnel understand their roles and responsibilities, which is crucial for effective management and compliance with regulations. It also helps maintain accountability and smooth operations within the facility.

What are the key infrastructure requirements for a pharmaceutical distribution facility?

The facility must comply with regulatory requirements, have an appropriate layout, sufficient capacity for storing pharmaceuticals, proper lighting, and temperature control systems. The storage areas should be designed specifically for different types of products.

What role does personnel training play in pharmaceutical distribution?

Personnel must be adequately trained to ensure they are competent in performing their duties. Proper training helps reduce errors, maintain compliance with regulations, and ensures personnel understand their responsibilities in maintaining product quality and safety.

How should pharmaceutical products be handled during the procurement process?

During procurement, the supplier must be qualified, ensuring they meet necessary standards such as GxP. The procurement process should also consider potential risks such as counterfeit products and irregular pricing. The apothecary in charge must oversee this process.

What are the essential steps involved in the self-inspection process for distribution facilities?

Self-inspection involves forming an independent team to evaluate compliance with standards. It should be conducted regularly, documenting findings and addressing any non-compliance issues. The process ensures continuous improvement in the distribution system.

What should be done when complaints or information about damaged or counterfeit products are received?

Complaints and information about damaged or counterfeit products should be collected, reviewed, and investigated according to written procedures. There must be documentation for each process, and actions taken must comply with regulatory guidelines.

How should returned pharmaceutical products be handled?

Returned pharmaceutical products should be stored separately from sellable goods, labeled clearly, and kept in a locked area. Products that require cold storage should not be returned. All returns must be evaluated by competent personnel and documented.

What are the differences between mandatory and voluntary product recalls?

A mandatory recall is initiated by a regulatory authority like BPOM, while a voluntary recall is initiated by the pharmaceutical company. Both processes involve removing products from circulation and documenting the procedure for safety and compliance.

How should pharmaceutical products be transported to ensure their integrity?

Transport must be managed carefully to prevent unauthorized access and ensure that conditions are suitable for the specific pharmaceutical products being transported. External transport providers must understand their responsibilities and how to manage issues that arise during transit.