Introduction to the Course
The background and content of the course will be presented to set the scene for the two days.
- Description of a data integrity model for data governance and data integrity in an Organisation
- An analytical data life cycle
- Regulatory issues with HPLC and CDS
- Compliance requirements for a CDS
Data Process Mapping: Why and How?
- What is Data Process Mapping?
- Why is it important?
- Emphasis on process, manual and computerised system assessment
Data Process Mapping in Practice
- How should Data Process Mapping help you to ensure protection of HPLC records and data integrity?
- How can Data Process mapping help to identify potential risks?
A Critical Review of the Current State of USP<1058>
- USP <1058> on Analytical Instrument Qualification and Computerised System Validation
- Principles of the USP chapter with its advantages and disadvantages for Data Integrity
- Typical pitfalls and deficiencies in practical context for standalone and computerized systems
Specifying Data Integrity Requirements for HPLC Instruments and CDS Software
- Based on the Workshop I: What critical parameters must be specified for HPLC instruments and the accompanying CDS application software to ensure data integrity?
- The workshop familiarises you with the concept of standard requirements for e.g. instrument control, audit trail functionality, security and access control, etc.
Ensuring HPLC Data Integrity: What Records Should Log Books Contain?
- Instrument and column log books are essential records for ensuring data integrity.
- What records should a log book contain?
- How often should these log books be reviewed?
- Paper or electronic - the right tool and how it should be used
Role of Suppliers in Data Integrity
- What is the role of a supplier in data integrity for specifications of liquid chromatographs?
- USP <1058> calls for suppliers to publish meaningful specifications.
- CDS software needs an architecture where data are acquired directly to the network, has a database and adequate technical controls for data integrity.
- IQ and OQ qualification protocols executed by a supplier’s engineer need to be reviewed before and after execution and ensure that records are complete, consistent and accurate.
Complete Data and Raw Data for HPLC Analysis
- FDA 21 CFR 211 regulations require complete data
- EU GMP Chapter 4 mentions raw data
- What do these terms mean and what is their impact on HPLC records from regulated analyses?
- What about hybrid systems are paper or electronic records the main records?
- Definition of e-records for an HPLC analysis
Controlling Chromatographic Integration and Data Processing
- Process methods and data integration
- Training in process methods with the focus on integration
- Automatically processing versus manual intervention: when can I manually integrate a peak?
- Process requirements for reporting data – audit trail, integration, calculation e.g. custom fields etc.
- Training in chromatographic integration in a regulated environment
- Manual intervention versus manual intervention: when can I manually integrate a peak?
Controlling Chromatographic Integration
- What should be included in an SOP for chromatographic integration?
- How can this be enforced by the CDS where possible?
- How can I evaluate integration and data integrity errors in my chromatogram?
An Introduction to the ECA Guide on Analytical Instrument Qualification and System Validation (AIQSV)
- Background to the ECA Guide on AIQSV
- Risk assessment to determine the USP <1058> group and sub-type based on intended use
- Lifecycle of analytical instruments and systems
- Practical qualification and validation examples
Second Person Review and its Importance in Ensuring Data Integrity
- Second person review is key to ensuring data integrity.
- Who should perform this task and what training and experience should they have?
- How to review HPLC analysis records and cross-correlations?
- How are consistency checks to be performed?
- What is review by exception and how should it be conducted?
- How can/should a CDS support the review?
Second Person Review of a CDS Audit Trail
- How will a second person review an HPLC audit trail?
- What is the scope of the procedure?
- How will you structure reporting and use the CDS to reduce review work?
- How will your procedure define review by exception?
Ways to Identify Data Manipulation and Falsification in HPLC Analyses
- Regulatory expectations for identification of falsification – an integral part of second person review and DI audits and investigations
- What to look out for from sample receipt to sample preparation
- From volumetric flask to loading the autosampler
- Data manipulation and falsification in the chromatography data system