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?
“The two days were very informative, educational and interesting. The design of the workshops was very well executed, and it was even fun.”
Sebastian Hahn, Sanofi-Aventis Deutschland GmbH, Live Online Training: HPLC Data Integrity, February 2021