GMPs for APIs

In this webinar we will discuss the regulatory expectations that apply to the production and control of active pharmaceutical ingredients.

The discussion will start with the introduction of ICH Q7, the internationally accepted GMP for APIs, discuss the international regulatory and compliance issues associated with this GMP and each of the main areas of ICH Q7 to include: personnel, buildings and facilities, process equipment, documents and records, materials, production and production controls, packaging, and laboratory controls.

Discussion will include how ICH Q7 supports contemporary Quality System concepts and is supplemented by guidance such as ICH Q10, the Pharmaceutical Quality System, ICH Q8,Pharmaceutical Development,ICH Q9 Quality Risk Management and ICH Q11, Development and Manufacture of Drug Substances. The impact of FDA guidance on Process Validation, Quality Metrics and Data Integrity will also be considered.

Why should you Attend: Anyone working in a firm that produces Active Pharmaceutical Ingredients, or is involved in any way in the production and control of Active Pharmaceutical Ingredients, should understand and follow ICH Q7, the GMP covering the production and control of active pharmaceutical ingredients (API).

Although this is not an official US regulation, it defines the requirements for a compliant active pharmaceutical Ingredient production operation. ICH Q7 is an integral part of the pharmaceutical GMPs in most jurisdictions outside of the United States.

Any firm that produces or provides drug product excipients (materials incorporated into a drug product) should understand the industry and regulatory expectations that the firm operate in compliance with a clearly defined quality system. Although there is no US GMP that officially applies to the production of pharmaceutical product excipients. Drug product manufacturers do expect their suppliers to have effective quality systems with documented production controls. ICH Q7A defines an appropriate quality system.

ICH Q7 is an international document that identifies an effective Quality Management System acceptable throughout the world and should be on the basis of quality system for any firm involved in the production of Active pharmaceutical ingredients, as well as excipients.

Areas Covered in the Session:

• Drug GMPs
• ICH Q7
• ICH Q8
• ICH Q9
• ICH Q10
• ICH Q11
• FDA Process Validation guidance
• Data Integrity
• Quality Metrics

• Quality Assurance Management and Staff
• Quality Control Management and Staff
• Production Management and Staff
• Senior Management
• Purchasing Personnel
• Quality Auditors