Discussion on Raw Material Methods and Specifications (Active and Inactive Ingredients) Referenced in UPS, EP, and JP Compendia

Duration: 60 Minutes
When establishing specifications for compendia items, it should be noted that there may be specific attributes of the inactive ingredient that are important for the company's product and/or manufacturing process but that are not identified as part of the compendia specifications. Thus appropriate testing and proper evaluations of all product ingredients can be established via the use of alternate methods to obtain true picture of ingredients.
Raw Material Methods
Instructor: Lamont M. Fulton
Product ID: 509975
Objectives of the Presentation
  • Acceptability of standards from alternative compendia (BP/EP/JP)
  • Justification for the use of a standard from the BP, EP, or JP in lieu of the USP/NF standard in the application
  • 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)
  • 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
  • The supplier's commitment to conforming to appropriate excipient GMP requirements
  • Characterization of the composition of the excipient
  • Regulatory information, (CFR, Mapp's, Guidance's, ICH, Orange book)
  • Description of the API and excipient manufacturing process and facility
Why Should you Attend
The FDA has approved hundreds of inactive ingredients for thousands of products with various dosage forms (routes of administration). The quantities and quality of each inactive ingredient is critical to the function and design of the final product formulation.

Thus, a particular dosage form, (tablets, creams injectable, etc.) with a specified route of administration, must provide information on the maximum potency contained per dosage strengths. Therefore, it is incumbent on the manufacturer of the proposed marketed product, to establish controls that will provide appropriate test, measure and consistent release of products.

Who will Benefit
  • Quality Assurance/Control
  • Product Development/Formulator / R & D Chemist
  • Analytical Chemist/QC Lab
  • Regulatory Affairs
  • Material Management
  • Regulatory consulting
  • Project managers
  • Technical services
  • Analytical and Quality
  • Formulation
  • Project Management
  • Regulatory Operations
  • Process Automation Manufacturing Operations
  • Process and Design Engineering
  • Quality Control
  • Utility Operations
$375
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Instructor Profile:
Mr. Lamont M. Fulton is President of Regulatory Direction LLc and has overForty years of Pharmaceutical experience (26 inregulatoryaffairs CMC).Mr. Fulton has had roles as both Manager and Director of Chemistry Manufacturing and Controls (CMC) Regulatory and labeling at both Branded(Merck, SmithKline, Wyeth) and Generic drugs firm (Mylan).

Prior to working as the leader to regulatory affairs departments, Mr. Fulton worked at the FDA as a Chemist reviewer in the center for drugs. While at the FDA, He also worked as anAnalyst in the office of regulatory affairs and international office of policy, dealing with FDA/ICH regulations and guidance for global initiatives.

Mr. Fulton's past experience in government and industry, including his current role as senior consultant, has allowed him the opportunity to develop relationship with various CMC partners(Pfizer, Johnson and Johnson, Bristol Myers Squibb, etc.). It has also afforded his consultancy the chance to assist and manage other multidisciplinary teamsachieve approval fordozens ofNDA's, ANDA's to the FDA, as well as provide help with several successful international drug applicationsto the EMEA, MHLW and ROW.

The blended years of both pharmaceutical quality and regulatory affairs has provided Mr.Fulton with a perspective to determine appropriate filing strategy and provide regulatory impact of changes in postâ??marketing products.

Mr. Fulton has BA degree in Chemistry from Cheyney University of Pennsylvania; where he studied under Dr.Taylor on the nature of terpenes and its various derivative. Certificate of Pharmaceutical training from University of Maryland school of Pharmacy / FDA program.

Mr. Fulton's affiliations included; GPhA (Generic Pharmaceutical Association), ACS American chemical society) RAP (Regulatory Affairs Professional society), PDA (Parenteral Drug Association); Sigma Xi.
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