Bob McDowall, R.D.McDowall
Yves Samson, Kereon
The aim of this one day course is to understand what can be defined as raw data and to explore the meaning of the term for manufacturing, laboratory and quality records. Is there harmonisation of US and EU GMP regulations? For example:
- What is a “quality decision” and what is the impact of having to define raw data for the process or system?
- Can raw data be equivalent to complete information and complete data?
- Should we treat manufacturing “information” and laboratory “data” as the same?
FDA GMP in 21 CFR 211 requires “complete information” for manufacturing records and “complete data” for laboratory records. In contrast, Chapter 4 of EU GMP on documentation contains in the Principle three sentences that are in apparent contradiction to the United States regulations:
- Records include the raw data which is used to generate other records
- For electronic records regulated users should define which data are to be used as raw data
- At least, all data on which quality decisions are based should be defined as raw data
In the days of harmonisation of regulations how can we reconcile these differences? This situation is compounded by the failure of EU GMP to define the term “raw data” in the regulations to help industry plan their approach to meeting these regulatory requirements.
- Managers and staff from Manufacturing, QC/QA and Analytical Development Laboratories of pharmaceutical companies
- Contract Research Organisation and Contract Manufacturing Organisation manufacturing, laboratory and QA personnel
- Auditors (internal and external) responsible for performing self-inspections or external audits and needing to understand and assess data integrity
Especially the Data Integrity Master Class course is directed to participants who have first experiences in Data Integrity, e.g. the ECA course “Data Integrity – Requirements for a GMP compliant Data Life Cycle".
Attendees will get a free electronic copy of ECA “GMP Data Governance and Data Integrity Guide” - Version 3
Data, Information and Knowledge
- Data vs information vs knowledge
- From knowledge to insight
- DIKI model
- Product, Prcocess, Data
- US GMP regulations: 211.68(b), 211.180(d), 211.188 and 211.194(a-e): complete data and complete information
- EU GMP Chapter 4 regulations – raw data principles outlined from a GMP perspective
Understanding GMP Definitions and Regulations for Raw Data
- Original record / record
- Raw data – MHRA GMP and US GLP definitions
- Data and metadata
- True copy
- Complete data
- Initial data
- Translating raw data for a GMP environment: should we treat manufacturing and laboratory the same when it comes to raw data?
Interpretation of Raw Data for Production Systems
- Raw Data for PLCs
- PLCs linked to a SCADA system
- SCADA linked to a Manufacturing Execution System
Interpretation of Raw Data for Laboratory Systems
- Hybrid CDS and manual input to the LIMS
- Electronic CDS with automatic transfer to the LIMS
- Managing sample management and preparation records
Workshop: Defining Raw Data for Production, QA and Laboratory Systems
Can a True Copy be Raw Data?
Workshop : What are Raw Data for Quality Decisions