EXCiPACT

EXCiPACT is a voluntary international scheme that provides independent third-party certification of manufacturers, suppliers and distributors of pharmaceutical ingredients. Our leading global excipient manufacturing sites have completed the audit requirements of EXCiPACT and we are the first excipient manufacturer to achieve EXCiPACT certification across multiple production facilities.

EXCiPACT at Croda Infographic

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Excipient sustainability - A user and a supplier perspective

To achieve their sustainability ambitions excipient users need to access excipients produced with lower embedded GHG emissions, little or no waste produced and with minimal impact on water quality and availability. As such, in the short-term excipient producers need to optimise processes and switch to renewable or low carbon sources of energy. To achieve the long-term ambitions of the pharmaceutical sector, excipient users and suppliers need to collaborate and share data to identify ways to make step change improvements and identify ways to deliver net zero ingredients within the confines of current legislation.

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Qualifying the EXCiPACT Certification Scheme

There has always been a regulatory requirement for Pharmaceutical manufacturers to audit their starting material suppliers, but with increasing and sustained use of 3rd party audit solutions, pharmaceutical manufacturers will need to qualify not only the excipient manufacturer but also the 3rd party certification scheme owner and any associated organisations that perform the audits. The use of the new IPEC GMP Certification Scheme Certification Body Qualification Guide by EXCiPACT is used to explain an efficient means of qualifying these organisations.

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Croda Pharma: The future of novel excipients

The importance of excipients and their specialised role in formulation development has been recognised in recent years, whether that be for targeting delivery of the drug, aesthetics of the final formulation, or shelf life of the final drug product. Some excipients play a simple role in drug formulations while others require an excipient with different properties to perform their job properly.

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What does our EXCiPACT certification mean for you?

• Confidence in excipient quality and supply chain security
• Reduced supplier audit burden; significant time and cost savings
• Ease of compliance to FDA/EU regulatory requirements

Find out more about the value of working with an EXCiPACT certified supplier by listening to our webinar.

Watch our EXCiPACT webinar on demand

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The pharmaceutical industry is highly regulated, and products of high and consistent quality are essential. When manufactured ingredients are used in drug or vaccines formulations, risk of quality failures must be minimised, and ultimately patient safety ensured.

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EXCiPACT

EXCiPACT at Croda Infographic

Globally connected

Enhanced coordination

Faster response

Access to experts

View related articles:

Excipient sustainability - A user and a supplier perspective

Qualifying the EXCiPACT Certification Scheme

Croda Pharma: The future of novel excipients

What does our EXCiPACT certification mean for you?

Product finder

Resources

Quality

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