Approved training courses

Course description

This course outlines the critical concerns when designing, controlling and monitoring the processes that assure the quality of APIs manufactured synthetically and via a variety of bioprocesses. The quality of a medicine depends in no small part on the quality of its ingredients, and in particular the active.Thus, the Qualified Person and other key professionals in dosage form manufacture must have a thorough understanding of how the manufacture and control of the active and its supply chain may influence the fitness for use of the finished product.

This is recognized by the regulators, especially in Europe, where the adoption of Directive 2004/27/EC has put the responsibility for assuring the quality of the active firmly on the shoulders of the dosage form manufacturer, with certain expectations specifically for the QP.

The course will include visits to local state-of-the-art API manufacturing facilities putting into practical perspective the key issues discussed in the lectures.

COURSE OUTLINE

Active Pharmaceutical Ingredients
• The Regulations
• EU and US regulations and guidelines
• Drug Master Files and Certificates of Suitability
• Key GMP guidance – ICH Q7

Manufacturing Processes and Quality
• Synthesis
• Purification and impurity control
• Packaging
• Process Validation

Supply Issues for the Dosage Form Manufacturer
• Supplier selection and audit
• Supply chain integrity
• Technical Agreements
• Certificates of Analysis

Bulk Biologicals and Biotech Products
• What is a Biological or Biotech Product?
• EU and US Regulatory Aspects
• Essential Characteristics of Biologicals
• Quality Aspects

Excipients
Regulatory Environment
GMP Guidances/Codes

Pre-requisites

Please speak to Aimee Harding, QP Administrator at NSF, about entry requirements for both QP training and/or postgraduate qualifications.

Additional info

Lunches and refreshments are included in the course fee plus a special 'course dinner' on the penultimate evening. Specially negotiated B&B rates are available. For further information please contact Aimee Harding, QP Administrator at NSF.

Venue

Marriott Hotel

Teaching method

Class/lab

City

Durham

Duration

3 day

Cost

£2290.00 GBP (plus VAT)

Training provider

NSF International

Email

qppharma@nsf.org

Tel

01751432999

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