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 Mapping help you ensure protection of HPLC records and data integrity?
- Development of short-term remediation as quick fixes and long-term solutions to move away from paper.
The current Version of USP <1058> for AIQ and its Impact on Data Integrity – Part 1 URS to OQ
- The updated USP <1058> has major changes that impact data integrity.
- The USP <1058> requires a user requirements specification, risk assessment to determine the Group based on intended use.
- A separate DQ phase followed by OQ testing against URS requirements.
- The requirements should cover both the chromatograph as well as the CDS application.
- Harmonisation of USP <1058> with Annex 15 clauses 2.5, 3.2 and 3.3.
Specifying Data Integrity Requirements for HPLC Instruments and CDS Software
- What critical parameters must be specified for HPLC instruments and the accompanying CDS application software to ensure data integrity?
- Aim of the workshop is to get attendees to outline requirements 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?
- Must a log book be paper or can a log be electronic?
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?
The current Version of USP <1058> for AIQ and its Impact on Data Integrity – Part 2 What Does PQ Really Mean?
- PQ is perhaps the most misunderstood part of the 4Qs model.
- The USP <1058> states that PQ consists of calibration, service, maintenance and monitoring of instrument performance.
- The USP <1058> links PQ back to the instrument URS. How will you comply with this?
- Proposed changes for the next version of USP<1058>
Second Person Review and its Importance in Ensuring Data Integrity
- Second person review (3rd and 4th eyes of the 4 eyes principle) 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-correlation and consistency checks to be performed.
- What is review by exception and how should it be conducted?
- Differences to a normal GMP review?
- How can CDS support the review?
Second Person Review Procedure
- How will a second person review of any HPLC Analysis be controlled and documented?
- What is the scope of the procedure?
- How will you use the CDS to reduce review work?
- How will your procedure define review by exception?
Metrics for HPLC Data Integrity
- To monitor and review chromatographic analysis and data integrity, regulatory guidance documents from WHO, MHRA and PIC/S require metrics to be generated.
- However, the PIC/S guidance contains a warning about metrics influencing analyst working and impacting DI.
- What metrics could be generated and reviewed for HPLC analysis?
- Why should metrics be generated automatically?