Dr Rainer Gnibl, GMP Inspector for EMA
Prof Edwin van den Heuvel, University of Technology Eindhoven
Dr Andreas König, Fidelio Healthcare
Dr Jens-Uwe Rengers, Akorn AG
Pia Lise Sandau, Novo Nordisk
This course examines regulatory requirements, provides insight into inspectors’ expectations and provides 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.
The U.S. FDA has set up an initiative to use Quality Metrics for risk based inspection planning and published a draft Guidance for Industry in July 2015 and a Technical Performance Guide in June 2016. There are currently some discussions on how to proceed.
All relevant guidances 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.
- an example for a PQR SOP with Annexes
- an example for a Management Review SOP
- real PQR examples
- extracts from real Management Reviews
Quality Reviews in the Context of FDA, EU and ICH - Requirements and Expectations
EU Product Quality Reviews in the Light of Inspections – Expectations of the Agencies
- 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
- 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)
Set up of efficient PQRs and APRs
- 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 …)
Workshop: Evaluation of given PQR Examples
- 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
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?
Novo Nordisk Case Study: Management Review - from Data Collection to Evaluation and Reporting
- Definition, scope, objectives
- Participants, responsibilities
- Topics to be presented: input and output
- KPIs per system
- Examples and experience
Vetter Case Study: Quality Reviews in Contract Manufacturing
- 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
Using KPI in Quality Reviews and in Communication with Authorities
- 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?
Review Management: Bringing them all together in an efficient Way
- Current status of the requirements
- Key areas and data to be submitted
- How industry can prepare to meet the expectations
Pre-course Session „Statistical Process Evaluation and Reporting“
- How to set up an integrated data, review and report management
- How to avoid double work
This pre-course session will provide you recommendations, tools and examples to apply statistical principles in your day-to-day business as well as to meet future challenges.
Working with statistical simulation tools, you will gain understanding of the consequences of appropriate and inappropriate performance parameters and a sound evaluation of data.
The Application of statistical Tools in Data Review
- Ongoing/data collection and management
- Interpretation, comparison and presentation of data
- Describing process capability and performance
- Control Charts; what is a trend and how to deal with it?
- Quality Metrics
- Documenting the outcomes; are we in control?
Quality Review Summary Report
- Descriptive Statistics
- Outlier detection
- Normality testing
Quality Review Performance
- Control Charts
- Capability Indices
The Session includes a Workshop with Minitab Software: What are the Data telling us?
A case study on analysing and interpreting process performance data.