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EXCiPACT is continuing to strengthen its leadership role in the pharmaceutical industry by advancing globally recognized excipient certification standards. Through its robust, independent certification scheme, it helps ensure that excipients used in medicinal products consistently meet high levels of quality, safety, and regulatory compliance.
This contributes to greater confidence across the pharmaceutical supply chain, supporting manufacturers, suppliers, and regulators in maintaining harmonized Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) expectations. The globally recognized certification scheme that ensures quality, safety, and consistency in the manufacture and distribution of pharmaceutical excipients is now a game changer for the industry, said Kaushik Desai, board member EXCiPACT.
We see pharmaceutical companies that use EXCiPACT achieve maximum return on their audit programmes, increased assurance of excipient quality, especially for imported materials and improved traceability throughout the excipient supply chain. In light of the recent incidents regarding excipient quality in India, third-party certification from a global body like EXCiPACT is gaining significant confidence, he added.
By integrating rigorous GMP and GDP standards, it provides a harmonized framework that helps suppliers meet regulatory expectations while giving pharmaceutical companies greater confidence in their quality standards. As regulatory scrutiny and global sourcing continue to increase, EXCiPACT serves as a trusted benchmark, reducing audit burdens and promoting transparency, reliability, and compliance across the excipients industry, Desai said at an event last month on 'Excipients: Value contribution to pharma industry', he noted.
Highlighting the need for flexible approaches to ensure patient safety, Desai noted that at trade shows, excipient suppliers are often first asked by new customers how they can demonstrate traceability, quality assurance, and regulatory compliance for their products. They also question whether global regulatory authorities would accept EXCiPACT certification.
In March 2025, EXCiPACT participated in the EMA (European Medicines Agency) Interested Parties Meeting, where its role in qualifying excipient suppliers was highlighted. It is increasingly being adopted across the industry for supplier qualification, said Desai.
The UK MHRA was also asked whether it had any concerns about industry use of EXCiPACT. It explained its expectations for how EXCiPACT should be applied, noting that the use of EXCiPACT certificates and audit reports is acceptable where a formalised risk assessment (FRA) indicates that EXCiPACT GMP is suitable for the relevant dosage form. It also confirmed that EXCiPACT is considered a qualified provider of audit reports, said Desai. Nigeria and Vietnam regulatory authorities have already recognised EXCiPACT certification for excipients, he said.
“Overall, pharmaceutical companies availing EXCiPACT achieve maximum value from their audit programmes, gain greater assurance of excipient quality, particularly for imported materials and benefit from enhanced traceability across the excipient supply chain,” said Desai.
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