Draft Specific Conditions of the Application of the
confidence that the excipient will meet its intended specifications for quality and purity All quality related activities shall be defined and documented A system of managing changes that could have an impact on excipient quality and compliance with agreed specifications shall be included
LEADING EXPERTISE ON EXCIPIENTS JOIN OUR NETWORK, MAKE A
Europe the hub of excipient expertise and know-how We represent all types and sizes of companies and make a meaningful impact on the industry’s future As a member of the IPEC Federation with our sister associations in the Americas, China, India and Japan, we strive to improve excipient quality and safety at the global level
IPEC EUROPE Excipients Council - Europe asbl JOIN OUR NETWORK
Europe the hub of excipient expertise and know-how We represent all types and sizes of companies and make a meaningful impact on the industry s future As a member of the IPEC Federation with our sister associations in the Americas, China, India and Japan, we strive to improve excipient quality and safety at the global level
DEFINITION OF ACTIVE PHARMACEUTICAL INGREDIENT
The moment an API is mixed with another API, or with an excipient, it is no more considered an API This is best illustrated by the guidelines mentioned below The current draft Guideline on submission of documentation for a multisource (generic) finished pharmaceutical product (FPP): quality part (QAS/10 373/Rev 1), line 1944, reads:
W0930-08-51 Correlation between excipient material attributes
The excipient material attributes for different grades of Pharmatose® 200M can be seen in Table 1a A screw speed of 530 rpm was used to feed the excipients in a volumetric mode Figure 1 shows the feed rate of the three grades at varying hopper levels(The hopper is completely filled at the start and is allowed to drain till empty)
YOUR NI HALATOI N GRADE LACTOSE - DFE Pharma
excipient in advanced pharma-ceutical applications With this knowledge we can advise our customers on the latest scientific developments DFE Pharma offers the following inhalation grade lactose brands: • Lactohale • Respitose® Production capabilities Within DFE Pharma, three production sites are fully committed to the production of
YOUR ORAL SOLID DOSE - DFE Pharma
leader in excipient solutions We develop, produce and supply excipients for use in oral solid dose and inhalation formulations, but as a supplier of complete solutions we do a lot more than that We work closely with pharma ceutical companies around the world, collaborating in original research, supporting their go to
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