Discussion on Raw Material Methods and Specifications 2018 is a webinar that covers topics such as:
- Justification for the use of a standard from the BP, EP, or JP in lieu of the USP/NF standard in the application
- Acceptability of Standards from Alternative Compendia (BP/EP/JP)
- Does compendia specification captures all of the tests necessary to ensure that the Active and inactive ingredient will perform as expected in the final drug formulation
- Evaluate supplier specifications and methods listed on suppliers C.O.A (perform side by side and compare limits, supplier and user should interact to discuss Mutual agreement on quality requirements
- Characterization of the composition of the excipient
- The supplier`s commitment to conforming to appropriate excipient GMP requirements
- Description of the API and excipient manufacturing process and facility
- Regulatory information, (CFR, Mapp`s, Guidance`s, ICH, Orange book)
Discussion on Raw Material Methods and Specifications 2018 is intended for:
- Product Development/Formulator / R & D Chemist
- Quality Assurance/Control
- Regulatory Affairs
- Analytical Chemist/QC Lab