APIs – How to Certify Your Active Substances as GMP Compliant

Day 1

What is required for GMP Compliance of Active Substances? – Regulatory View and Findings

• EU Directive 2004/27/EC – What are the requirements
• What are the expectations from API Manufacturers
• What are the expectations of Secondary Manufacturers
• How will regulators assess compliance with these requirements
• What are the common critical and major deficiencies

ICH Q7a and EU GMP Guide Part II

• History of GMP for APIs
• What role do these documents play
• FDA Draft Guidance
• Differences and similarities with the EU GMP requirements for APIs
• GMP requirements outlined
• How to go about implementing the requirements
• How will manufacturers comply with FDA and ICH requirements

Networking and Coffee

Implications of EU Directive 2004/27/EC on Drug Product Manufacturers

• What role should manufactures of the secondary products play in enforcing these requirements?
• What is the impact on manufacturers
• How to apply the requirements to non EU API sites
• What impact will this have on the cost of APIs

Open Forum Discussion

• What if existing supplier does not comply (after audit)?
• What is the role and the constraints of Risk Assessment?
• What about risk mitigation? (additional testing?)

Lunch

Workshop I: How to identify and select a GMP Compliant API Manufacturer

• Assessing the rational for GMP relevance of activities
• Identifying the critical processing steps
• Key documentation

Developing a Sourcing Strategy for APIs

• Developing requirements
• Assessment of potential suppliers (supplier auditing procedure)
• Resource and cost implication on auditing non EU API sites
• Maintenance/policing GMP compliance at the supply site

Networking and Tea

Guidance for Approval of Excipients and their Manufacturers

• Review of IQA GMP guideline (PS9001:2002) for pharmaceutical excipients

General Discussion

Day 2

Summary of Day One

Quality Management Systems for APIs

• What is a QMS
• How to identify what is required
• ISO 9001, QMS requirements
• Developing a Quality Culture at organisation level
• Action planning and implementation
• Reprocessing and reworking

Understanding GMP-relevant Activities for API Manufacture

• Understanding the GMP-relevant activities
• Developing a rationale for GMP activities
• Critical parameters and steps during manufacture
• Risk assessment for active substances
• CAPA for active substances
• Gap analysis and action planning

Networking and Coffee

What to expect when Auditing an API Site

• Critical steps (handling Manufacturing Deviations)
• Documentation and systems review
• Facilities and support services
• Validation
• Calibration
• Testing laboratories
• Packaging and labelling
• Storage and distribution

Open Forum Discussion

• What is the QP declaration concerning GMP compliance of active substances?
• How do you guard against counterfeit active substances?

Lunch

Workshop II: Handling Planned Change and Deviations

EU Inspection Procedures and Trends for Active Substances

(Compilation of Community Procedures on Inspections and Exchange of Information)

• Process or Product related
• Format of Inspection reports
• Classification of Observations - Critical, Major, Other (Minor)
• Frequency of Inspections
• Impact of MRAs
• EU Procedures on Inspections and Exchange of Information
• GMP Compliance Inspections for Active Substances (APIs)
• Key aspects of QS
• Critical and non-critical steps
• Inspection/audit report(s)
• Contracts
• Responsibilities of Qualified Person (products)

Networking and Tea

Maximising Benefits from Auditing an API Site

• Recording deviations
• Following up CAPAs
• Issues around change control
• Managing expectations
• Maintaining secure relationships

General Discussion

End of Seminar

Speaker

Dr David Inglis