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Session 1: What is needed – Regulatory Review
- Review
EU and FDA regulations:
- Mentions
of Outsourcing in GMPS:
- EU
and US GMPs
- ICH
Q7 for APIs
- Q10
– Pharmaceutical Quality System Requirements for Outsourcing
- UPDATE – NEW HOT TOPIC: EU concept paper on revision of
chapter 7 regarding the use of contractors:
Session 2: Initial Selection and Preparation for Audit /
Initiation Visit
- URS
– reviewing and collating the requirements and expectations for this
contract inside your own company
- Information
gathering: which organizations might be suitable:
- Factors
to consider
- Recommendations
- Financial
stability of the company
- Initial
risk assessment based on your URS and initial contact with organizations
- Audit
planning
Session
3: Workshop
Participants will work in small groups to identify risks associated with the
use of contract manufacturers and to assign them risk ranking numbers. The class will then work together to identify
priorities and use them to develop a quality / technical agreement,
highlighting high risk items.
Session 4: Auditing an Outsourced Operation and Ongoing
Oversight
- Risk
(and time) management during auditing: focus on major items
- Confidentiality
issues
- Close-out
and report writing
- Managing
corrective actions
Ongoing
oversight of outsourcing: remote and on-site |