This course examines regulatory requirements, provides insight into inspectors’ expectations and explains tools for improving your documented review processes.
Based on real examples you will learn how you can implement and improve your Quality Reviews and use them more efficiently.
Background
Quality Reviews and Metrics are critical GMP elements. They are an integral part of a pharmaceutical quality system and provide an opportunity to assess and control relevant processes.
Both parts of the EU-GMP Guidelines require the Product Quality Review (PQR) to verify the consistency and appropriateness of existing processes, but also to identify product and process improvement opportunities.
The FDA 21CFR 211 requires an Annual Product Review (APR) to evaluate annually the quality standards of each drug product.
All relevant guidance do also consider a Management Review to be an appropriate instrument to assess adequacy and effectiveness of quality systems.
All these different reviews could result in a tremendous work load or they can be performed in an efficient way with useful results – depending on how they are organised. Therefore it is very important to understand the requirements and the idea behind it and to see how these tools can be used more efficiently.
Target Group
This Education Course is designed for managers, supervisors and all other staff members in the pharmaceutical and API industry who are involved in preparing and compiling Quality Reviews and Metrics.
Every participant will get:
an example for PQR SOP Annexes
an example for a Management Review SOP
real PQR examples
extracts from real Management Reviews
Programme
Quality Reviews in the Context of FDA, EU and ICH Requirements and Expectations
EU-GMP: which types of Quality Reviews are required?
EU Quality System Review (overview)
How to achieve EU-GMP compliance
ICH/US-FDA view on the situation (overview)
EU Product Quality Review (PQR)
Technical terms and aims of PQR
What documents and data should be reviewed?
Are EU-requirements the same for APIs & medicinal products?
What about US-FDA and ICH?
EU Product Quality Reviews in the Light of Inspections – Expectations of the Agencies
Inspectors view on critical parts of EU-PQR
Practical implementation and inspection
PQR and contract manufacturing
Comparison EU-PQR and US-APQR (inspectors point of view)
PQR and APR
How to combine PQR and APR in an efficient way
Well-proven PQR/APR designs
Interface to Regulatory Affairs
Certainties (PQR/APR in Custom Manufacturing, how to deal with limited numbers of batches …)
Set up of efficient PQRs and APRs
How to profit from existing QA Systems in PQR/APR and vice versa
Best practices
Time/efforts needed
Ongoing data collection
Foreseeable complications/advantages
Well-proven examples
Workshop: Evaluation of given PQR-Examples Evaluate with other delegates the content and lay-out of given PQR-examples and discuss it with the speakers:
What is useful?
What is ambiguous?
What could be improved?
Management Review
Definition, scope, objectives
Organisation
Participants, responsibilities
Topics to be presented: input and output
KPIs per system
Examples and experience
Kite Pharma Case Study: Management Review - from Data Collection to Evaluation and Reporting
Collection and preparation of data: time/efforts needed, automatic vs. manual data capture
Evaluation of deviations and changes
Interpretation of data: what is the data telling us?
Testimonials