Setting Specifications for Drug Substances and Drug Products

Why Should You Attend:

A specification is defined as a list of tests, references to analytical procedures and appropriate acceptance criteria that are numerical limits, ranges or other criteria for the tests described. It establishes the set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use. ``Conformance to specifications'' means that the drug substance and drug product, when tested according to the listed analytical procedures and meeting the listed acceptance criteria.

Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval.

Specifications are one part of a total control strategy for the drug substance and drug product designed to ensure product quality and consistency. Other parts of this strategy include thorough product characterization during development, upon which specifications are based and adherence to good manufacturing practices (GMP's), e.g., suitable facilities, a validated manufacturing process, validated test procedures, raw materials testing, in-process testing and stability testing.

Specifications are chosen to confirm the quality of the drug substance and drug product rather than to establish full characterization and should focus on those characteristics found to be useful in ensuring the safety and efficacy of the drug substance and drug product.

This webinar will teach you to set specifications for drug substance and drug product, including use of release test data, long term stability; accelerated stability & special stability studies. The webinar will also cover changing specifications during lifecycle management.

Areas Covered in the Webinar:

• Setting initial specifications
• How to use available data and justify specifications
• ICH specific requirements will be discussed
• Information required to be submitted during the lifecycle
• Updating the specifications during development & commercial phases

Who Will Benefit:

• Manufacturing
• Supply chain
• Technical operations
• Quality control
• Quality assurance
• Regulatory affairs

Peggy Berry
Founder, Synergy Consulting LLC

Peggy J. Berry, MBA, RAC, is the president and CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was vice president of regulatory affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was vice president of regulatory affairs and quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held regulatory affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

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