EXCiPACT has two core standards covering manufacturing operations (GMP) and repacking and relabeling activities (GDP). However, the excipient supply chain includes those who only transport and store the materials in a facility.
For these organisations, the GDP standard is too detailed as it includes repacking operations where the excipient may be exposed to the environment. To help transport and warehousing operations maintain high standards of excipient safety EXCiPACT has developed a focused, leaner, standard for these operations.
This is called Good Warehousing Practices (GWP).
The objective of excipient GWP is to ensure that:
• the receipt, storage, despatch, and transportation of closed pack excipients maintain material with the desired quality characteristics,
• it assures product integrity, traceability, and consistent quality,
• it avoids product contamination, and
• it ensures that appropriate records are maintained.
Since the operations in the warehouse are much simpler than those operations practised at excipient manufacturers and distributors, audit durations are likely to be shorter with many being completed in one day.
As a result, the EXCiPACT Certification fee is only €2000 for a 3-year certificate for these operations.
More details can be found here or requested at info@excipact.org
Below you can find the webinar held earlier in 2021 by Dr. Iain Moore – President of EXCiPACT.