Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs)

Why Should You Attend:

ICH Q7, (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) will be the primary document used to define Good Manufacturing Practices (GMPs) for Active Pharmaceutical Ingredients (APIs). In order define GMP requirements for APIs throughout product lifecycle however, the ICH Q7 Working Group noted that portions of ICH Q10 (Pharmaceutical Quality System), ICH Q11, (Development and Manufacture of Drug Substances), ICH Q8 (R2), PART II (Pharmaceutical Development) and ICH Q9, (Quality Risk Management) be reviewed as well.

Learning Objectives:

• Understand the roles of quality management, quality personnel and production in ensuring GMP manufacture of the APIs under an appropriate system for managing quality, as required by regulatory authorities worldwide.
• Firms involved in contract manufacturing of APIs will better understand requirements that must be met in order to satisfy their obligations to the customer to use GMPs under an appropriate system for managing quality. In addition, contract manufacturers will remain within compliance.
• Understand and apply requirements for GMPs for APIs, as defined by ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients).
• Understand the level of GMPs required for APIs during each stage of the product lifecycle.

Areas Covered in the Webinar:

• ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• Applicable portions of the following documents will be discussed as well, in order to define GMPs for APIs during each stage of the product lifecycle per Working Group for ICH Q7:
• ICH Q10 (Pharmaceutical Quality System),
• ICH Q11 (Development and Manufacture of Drug Substances),
• ICH Q8(R2), PART II (Pharmaceutical Development) and
• ICH Q9 (Quality Risk Management)

Who Will Benefit:

• Quality management
• Quality personnel/Quality control unit personnel
• Regulatory affairs professionals
• Production personnel
• Quality auditors
• Compliance professionals
• Quality engineers

Stephanie Cooke
Consultant, Cooke Consulting, Inc

Stephanie Cooke is the President/CEO of Cooke Consulting, Inc., using her 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biopharmaceutical, medical device and nutraceutical firms. Her broad-based experience includes preparation of regulatory dossiers for human and animal pharmaceutical and biotech products, drug/device combination products and medical devices in all stages of development (INDs, NDAs, post-marketing, orphan drug submissions, 510ks, PMAs and HDEs). She also has extensive QA and validation experience, hosting many compliance audits conducted by FDA, ISO and other international regulatory bodies, conduct/management of auditing program to qualify contract manufacturers and vendors of raw materials, APIs, product release experience in manufacturing environments and for companies using contract manufacturers, responsibility for QMS for all product types (CAPA, Complaint, Document Control systems), stability programs, as well as preparation/performance of manufacturing process validation, sterilization validation (EtO, steam, gamma), aseptic processing, qualification of cleanrooms/water systems and qualification of equipment.

Stephanie worked for Scīele Pharma from 2005-2009 and was VP of Regulatory Affairs, Quality Assurance/Validation for Scīele, leaving in 2009 to start Cooke Consulting. She also held various senior RA, QA and validation positions at Merial, Bayer, Cryolife, Theragenics and other pharmaceutical, biotech and device companies, after beginning in industry as a lab tech and as a certified as a Microbiologist. She has a BS in Biology and an M.S. in Molecular Genetics and Biochemistry.

Follow us :