Distribution is a crucial aspect in ensuring the quality of pharmaceutical products. To ensure quality throughout the distribution process, product quality needs to be monitored from the moment they enter the warehouse until they reach the hands of consumers. Medical Device Distributors (PAK) are legal entities licensed to procure, store, and distribute drugs and/or pharmaceutical materials in large quantities according to regulatory provisions. The goal is to provide healthcare services where medical equipment distributed can always be effectively functional, including efforts to ensure the provision of safe, reliable, and fit-for-use medical devices.
There are some components of requirements that must be fulfilled by a PAK to comply with the CDAKB requirements:
- Must have a quality management system: A quality management system must be implemented to manage data on acceptance, storage, distribution, and sale of medical devices effectively and in accordance with applicable requirements.
- Must provide evidence of managing personnel resources related to the operation.
- Must have buildings and facilities suitable for proper medical device distribution methods.
- Must have a good inventory storage and handling system.
- Able to trace products: The company must be able to trace distributed devices by including data containing the customer’s name, manufacturer’s name, serial number, type, quantity, and marketing authorization number.
- Handling customer complaints: The company must have an effective customer complaint handling system.
- Handling Field Safety Corrective Action (FSCA)
- Must have a system for returning medical devices.
- Must have a mechanism for medical device destruction.
- Identification of illegal medical devices that do not meet requirements.
- Internal audit: The company must conduct regular internal audits to ensure the quality and safety of medical devices.
- Management review: The company must have an effective management review system to ensure the quality and safety of medical devices.
- Evidence of controlling third-party activities (outsource activity)
Reference:
Permenkes No.4 Tahun 2014
