- In March 2020, BPOM released a revised version of Good Distribution Practices (GDP) No 6/2020, replacing the same regulation (No 9/2019) which released in 2019. Just a year after the previous version was issued, but many chapters were amended in the current version, as follows:
- Premise and equipment (chapter III): 4 new points have been added
- Operational (Chapter IV): 8 new points have been added
- Transportation (chapter VII): 13 new points have been added
- Contract distribution organization (chapter VIII): 8 new points have been added
- Documentation (chapter IX): 17 new points have been added
This new regulation will impact all the stakeholders from the pharmaceutical supply chain. As BPOM urged that this regulation immediately become effective, thus they need to understand how they will adapt to the changes this regulation brings.
Distribution is an important activity in the integrated supply-chain management of pharmaceutical products because it can affect the quality and identity of pharmaceutical products during any of the steps involved (from procurement, purchasing, storage, distribution, transportation, documentation and record-keeping practices), it also must deal with and prevent the introduction of counterfeits to the marketplace via distribution chains.
Just like in the manufacturing facility, many aspect in the distribution activities use computer system in the GDP operation, but there haven’t been any clear requirements for computer systems from the regulation. In this revised version, computer systems have been mentioned several times, from validation requirements to data integrity requirements. This revised version gives more clarity in terms of how computer systems can be used in some aspects of GDP, one of them being documentation management for example.
Computer system requirement
Validation requirement (Chapter III – Premise and Equipment, Sub chapter Computer System)
A computer system used in a distribution facility is not excluded from validation requirements. With regard to this regulation, the user at least should perform verification and control against data entry, accuracy, and system security including access to the system.
Apart from this, the regulation requires computer systems to have a traceable audit trail, one important feature which regulated companies sometimes neglect. Other Computerised System Validation (CSV) requirements are printouts, archiving, incident management, and business continuity planning when the system is experiencing a breakdown
The regulation limits the scope of which computer systems must be validated, such as the system used for storage, purchasing-distribution, and financial transaction, as well as supplier and customer data management. See section Document type and its requirements (below) for further details.
Data Integrity Requirement (Chapter IX – Documentation)
The computer system used in a distribution facility (either for purchasing activity, inventory management or distribution record) must fulfil basic data integrity requirements such as attributable, legible, contemporaneous, original, accurate, enduring, available, and complete. See section Document type and its requirements for further details.
Document type and its requirements
In the GDP operation, there are 3 types of documentation system which must ensure data integrity and require CSV (if they use an electronic system). These are purchasing documentation, distribution documentation, and inventory documentation.
1. Purchasing Documentation & Distribution Documentation
- Purchasing documentation comprises Purchase Order and supplier delivery order. Both documents must be attached together for ease of traceability
- Distribution documentation comprises of Sales Order from customer and delivery order. Both documents must be attached together for ease of traceability
- The electronic system can pertain detailed information from Purchase Order: detail of distribution facility, responsible Pharmacist, supplier, drug ordered
- Access to the systems is limited only to an Authorized user (responsible Pharmacist)
- The electronic system can retain all the product traceability information for at least 3 years
- The data from electronic system must be easily retrieved and evaluated at any time when required
- Distribution documentation related to serialization has to fulfil requirement according to its respective regulation
2. Inventory Documentation
- The electronic system can record detailed information from inventory, as recorded in a manual stock card, such as: detail of drug, material receiving/outgoing, quantity (balance, incoming, outgoing), batch number, and operator attributes
- The electronic system can retain material movement information for at least 3 years
- Has other documentation system in place, in case there is a system breakdown
- Possible to have a copy or printouts
- There should be an audit trail function to record all modifications to the data
The amendment is intended to ensure that the quality and identity of pharmaceutical products is maintained during all aspect of the distribution process to achieve the ultimate goal in terms of delivering guaranteed product quality and patient safety.
CSV projects can be a challenge for those who are not familiar with it, even for some big companies. It is important to assess the need to involve Subject Matter Expert (SME)/Consultant for this purpose.
- Peraturan Badan Pengawas Obat dan Makanan Nomor 6 Tahun 2020 Tentang Perubahan atas Peraturan Badan Pengawas Obat dan Makanan No 9 Tahun 2019 Tentang Pedoman Teknis Cara Distribusi Obat yang Baik, Badan Pengawas Obat dan Makanan Republik Indonesia