- GMP and Compliance
- GMP Auditor Training
- How to Audit API Manufacturers
- Introduction to Sterile Product Manufacture for New Starters and Junior Staff
- Introduction to Sterile Product Manufacture for those with a cGMP basic understanding
- OOS Investigations in a GMP Environment
- Pharmaceutical Documentation
- Preformulation Studies for Tablet Development
- Writing effective SOPs in a GMP environment
- Pharmaceutical Product Development
- Pharmaceutical Manufacturing Support
- Pharmaceutical R&D Support
- In-house Training Courses
How to Audit API Manufacturers
No Course Dates Currently Available
Overview
This one day seminar is aimed at QA staff in drug product manufacturers and especially their QPs who have specific responsibilities under directive 2004/27/EC.
QPs are required to declare that the active materials used in each of their products have been manufactured to GMP as interpreted by the EU.
Participants will learn about the legislators perspectives and the key differences between APIs and products, which lead to different audit techniques and thought processes when auditing API manufacturers.
The seminar includes:- The background to current GMPs for APIs
- FDA and EU interpretation of GMPs for APIs
- Specific opportunities from the guidelines that API manufacturers may exploit
- Specifics of what to look for when auditing an API site
Who Should Attend?
- Supplier auditors for drug product manufacturers
- QPs in manufacture of drug products
- QA managers who support the QP / declaration
- QC managers of drug products manufacturers
- Production managers of drug products manufacturers
Course Programme
The course will commence with coffee/tea and registration from 8.30, course proper at 9.00 and we anticipate the course will finish at 17.00 each day
Background to ICHQ7 and EU GMP Guidelines Part II
- History of GMP for APIs within EU and USA
- What role do these documents play?
- How they will be enforced?
- How to go about implementing the requirements
- GMP expectations of the API Manufacturer
Why Audit API Manufacturers?
- EU Directive 2004/27/EC (Regulator's view)
- Recent legislation and practice
- Role of products manufacturers
- Regulatory review of audit reports
- Regulatory expectations of the API manufacturer
Workshop 1 - Handling Manufacturing Deviations
- Basis of proactive deviation management
- Identifying and documenting GMP non-compliance incidents
- Monitoring and reporting
- Key aspects of knowledge management
- Framework of critical deviation management
- Continuing governance of critical deviations management
Auditing of an API site (I)
- General preparations
- Quality (Management) System
- Facilities and support services
- Validation activities
- Summary of Key Issues
Auditing of an API site (II) + Open Forum
- SOPs and SOP training
- Materials and Production Controls
- Calibration
- Testing laboratories (QA/QC)
- Packaging and labelling
- Storage and distribution
Implications of EU Directive 2004/27/EC on Medicinal Product Manufacturers
- Role of medicinal product manufacturers (including legal responsibilities)
- Developing requirements
- Risk assessment
- Assessment of potential suppliers
- Resource and cost implications - supplier auditing
- Decision making and managing risks
- Developing contracts
- Maintenance/policing of GMP compliance at the supplying site
Summary of key issues
17.00 Close of Seminar
| What people said about How to Audit API Manufacturers |
|---|
"An excellent course, I would recommend to colleagues" "David is great at simplifying and delivering ideas" "David has great knowledge and experience of the area, notes were encyclopaedic" |
