Dr Rainer Gnibl, GMP Inspector for EMA
Arno Hoekstra, Kite Pharma
Dr Andreas König, Fidelio Healthcare
Dr Jens-Uwe Rengers, JeRo Consulting
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.
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.
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.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html
you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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?
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 …)
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)
Discussion of given PQR-Examples
Based on real examples, the speaker will discuss the content and lay-out of PQRs:
- What is useful?
- What is ambiguous?
- What could be improved?
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
- Definition, scope, objectives
- Participants, responsibilities
- Topics to be presented: input and output
- KPIs per system
- Examples and experience
Using KPI in Quality Reviews and in Communication with Authorities
- Current status of the requirements
- Key areas and data to be submitted
- How industry can prepare to meet the expectations
Quality Reviews in Contract Manufacturing
- Customer QMRs - content, scope, frequency, organisation
- Interface with Business Management Reviews
- Assessment of data, trending and decision making
- Actions, follow-up
- „Face to Face“ or telecon?
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?
- How to report the data and information gained
Review Management: Bringing them all together in an efficient Way
- How to set up an integrated data, review and Report management
- How to avoid double work