Discussion on Raw Material Methods and Specifications 2018

Topics

• 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)

Who should Attend

• Product Development/Formulator / R & D Chemist
• Quality Assurance/Control
• Regulatory Affairs
• Analytical Chemist/QC Lab