Ensuring Control of Chromatographs, Integration and Results
20/21 January 2027
Course No. 22113
Speakers
Dr Bob McDowall
R.D. McDowall Ltd.
Dr Christine Mladek
Boehringer Ingelheim Pharma
Dr Markus Dathe
F. Hoffmann-La Roche
Target Group
This Live Online Training is intended for experienced chromatographers, HPLC laboratory supervisors, QC laboratory managers and employees in Quality Assurance.
Objectives
The objectives of this Live Online Training are:
To provide tools to enable GMP regulated analytical laboratories to map chromatographic processes and identify risks and vulnerabilities in their records
To understand pros and cons of USP <1058> for analytical instrument qualification and data Integrity
Take the attendees through key stages of chromatographic processes highlighting the areas where control is required
How to identify falsification and data manipulation in HPLC analyses
Background
Chromatography, a pivotal analytical technique in pharmaceutical analytical development and quality control, is governed by major pharmacopoeias and FDA guidelines. Despite its importance, Chromatography Data Systems (CDS) have faced significant compliance issues, including data falsification and manipulation, highlighted by the Able Laboratories case in 2005. This Live Online Training offers practical advice on ensuring data integrity in chromatography, processing methods and conducting effective second person reviews, besides insights into the latest regulatory and USP requirements for chromatographic analysis in GMP-regulated laboratories. The emphasis will be on the following:
Data process mapping as a technique to identify risks and vulnerabilities to data and records
Understanding the changes in the new USP <1058> for Analytical Instrument Qualification (AIQ)
The use of log books to ensure data integrity in the chromatography laboratory
The role of suppliers in ensuring data integrity for chromatographs and CDS application Software
Controlling chromatographic integration in a GMP context: when can integration parameters and manual integration be performed?
Understanding the requirements for complete data and raw data
Second person review for ensuring chromatographic data Integrity
Metrics for monitoring data integrity in HPLC laboratories
Programme
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
WORKSHOP I 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 Draft Update 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
Workshop II 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?
WORKSHOP III 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?
WORKSHOP IV 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
Further Information
Technical Requirements We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT) ECA Members € 1,890 APIC Members € 1,990 Non-ECA Members € 2,090 EU GMP Inspectorates € 1,045 The fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
