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The International Pharmaceutical Excipients Council (IPEC) has released its Good Distribution Practices (GDP) guideline version 3, 2024, jointly developed by a team consisting of members from IPEC Europe and IPEC-Americas. Industry experts noted that this would propel Indian manufacturers to adhere to stringent regulatory standards for excipients to align with international expectations.
A major chunk of excipients imported from China is utilised for domestic pharma manufacturing and only 10 percent of excipients manufactured in India are currently being used in the US and Europe.
According to Kaushik Desai, general secretary, IPEC India, “The GDP guide for excipients has been prepared in the light of having issues with use of substandard excipients resulting in fatalities in some parts of the globe. It brings clarity on the profession as distributors. The scope of distributor has been widened for better understanding. This guidance document will be of great support in following good distribution practices to all excipients suppliers and it will bring Indian suppliers align with uniform global practices in delivering safe and quality excipients”.
Excipients play a critical role in the manufacture of medicines by helping to preserve the efficacy, safety, and stability of active pharmaceutical ingredients (APIs), and help to ensure that they deliver their promised benefits to patients.
The Good Distribution Practices Guideline has proven to be an important element in the supply chain management and control of pharmaceutical starting materials. The updated guide provides a comprehensive tool for companies operating within the supply chain of pharmaceutical excipients. Several serious incidents in the past, and more recently over the past two years resulted in the deaths of many children caused by a lack of supply chain security, inappropriate handling of pharmaceutical excipients and falsification of records. This has moved regulators, users, manufacturers and distributors to take action, stated the communication issued by IPEC.
It is IPEC Federation’s position that those involved throughout the entire supply chain for the distribution of pharmaceutical excipients as well as stakeholders should rigorously promote and apply the principles of Good Distribution Practices (GDP) as provided in this updated guideline.
IPEC Federation strongly believes that the application of GDP by all stakeholders in the excipient supply chain will help to avoid incidents resulting from the use of sub-standard excipients in drug products.
For the purpose of this document ‘distributors’ includes for example, those parties involved in trade and distribution, re-processors, re-packagers, transport and warehousing companies, forwarding agents, brokers, traders, and suppliers other than the original manufacturer.
To begin with, the guidance document will be available, initially exclusively to IPEC members for a three-month period, on the IPEC Federation and national/regional members’ websites. Thereafter, the guide will be made available to the general public.
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