Bob McDowall, R.D.McDowall Ltd.
Yves Samson, Kereon AG
The aim of this one day course is to understand what can be defined as raw data and 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
- CRO and CMO 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
Cutting Through the Confusion and Fog of Regulatory Terms
Currently there are many terms used in GMP regulations and data integrity guidance documents. What do they mean? How are they relevant to debate? Definition and interpretation of
Interpretation of Raw Data for Production Systems
- 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?
Using a manufacturing process that is automated by standalone PLCs, PLCs linked to a SCADA system and an automated Manufacturing Execution System, what constitutes raw data will be outlined.
Raw Data for PLCs
PLCs linked to a SCADA system
SCADA linked to a Manufacturing Execution System
Interpretation of Raw Data for Laboratory Systems
Using a process involving a chromatography data system and a LIMS, what constitutes raw data will be outlined in two scenarios
Can a True Copy be Raw Data?
- Hybrid CDS and manual input to the LIMS
- Electronic CDS with automatic transfer to the LIMS
- Managing sample management and preparation records
This brief presentation will start from the definitions of raw data and true copy and explore if and how a true copy can be considered raw data.
Workshop: Defining Raw Data for Production, QA and Laboratory Systems
This workshop is intended to reinforce the two previous presentations. Attendees will be given laboratory, quality assurance and production scenarios to define raw data. Outputs will be discussed with the course.
Workshop: What are Raw Data for quality decisions
- Identifying GMP quality decisions?
- For each quality decision – define the raw data