Implementation of GDP WHO Technical Series No. 937, 2006
Entering the free-market era with the industry and society dynamics, there are many challenges emerged particularly in the pharmaceutical and healthcare industry. Countermeasures towards present and future problem become more important, not only to the regulatory bodies, but also to other parties involved, such as the manufacturers, distributors, retailers, paramedics, including the consumers (patients).
As a leading company in pharmaceutical distribution, AAM has a strong commitment to respond the challenges posed by the market and business industry, at the same time to ascertain the fulfillment of regulatory requirement.
Answering these various challenges, AAM brings forth its 3 competitive advantages, they are:
- Strong market exploration
- Reliable Supply Chain Solution
- Knowledge based Organization
To ensure sufficient capability in pharmaceutical distribution, AAM sees it necessary to assure a reliable handling method throughout the distribution process, with the purpose to:
- Preserve the identical properties of drug and healthcare product from the manufacturer release to its administration by the patients
- Fulfill regulatory requirement related to Good Distribution Practices
- Meet the Product Specific Requirements and Distribution Service Standard which are established by the manufacturer
- Undertake the competition challenges in the Asean Free Trade Area
As a commitment to provide a reliable supply chain solution, AAM continuously apply the Good Distribution Practices guidelines in relevant activities. Prior to applying the Good Distribution Practice of WHO 2006 standard, AAM had been observing the guidelines from the European Union, EU-Directives, no 94/C 63/03, also known as EU-GDP. Afterward, AAM updated its GDP reference to those released by the WHO in the 2006
According to the GDP guidelines, the quality of pharmaceutical products can be affected by a lack of adequate control over the numerous activities which occur during the distribution process. Furthermore, it is also important to ensure the establishment, development, maintenance and control over the activities involved in the distribution process. The objective of these guidelines is to assist in ensuring the quality and integrity of pharmaceutical products during all aspects of the distribution process.
The guidelines cover most activities in the distribution process, including the process of planning, receiving, storage, and dispatch. It starts with the activity of the physical checking in against the document since it was accepted from the Principal, verifying conformance of products received, until the handover to customer and recording activity.
One example of GDP application is the Cold Chain Product Handling. AAM CCP Storage System has been certified with Good Distribution Practices standard, starting from maintaining specific storage, desirable conditioned temperature, equipped with temperature alarm, which will be triggered when temperature reaches below or exceeds the required temperature. AAM ensures the quality of Cold Chain Product, since the receiving process from the principal until product delivery to the customer site in validated acceptable condition.
With robust information system capability, AAM promotes strong partnership with the principal in ensuring a reliable traceability of distribution transactions, enabling retrieval of receiving and dispatch records in accurate, fast, and comprehensive manner.
Based on the quality management system in place, the GDP guidelines were then adopted through in internal standardization steps, implementation, and self-inspection, before finally submitted for a certification process. After a series of audit, conducted on 2 – 4 December 2008, these efforts have accomplished a certification of Good Distribution Practices in accordance to World Health Organization standard, Technical Series no. 937, 2006.
As the organization continues to develop, and so does the market condition, AAM recognize the possibility that the regulatory bodies and drug manufacturers will advance in the improvement of healthcare quality. With the same manner and determination, the effort to progressively improve the quality of distribution process and material handling shall always become major part of integrated solution in PT Anugrah Argon Medica.