To provide tools to enable GMP regulated analytical laboratories to map chromatographic processes and identify risks and vulnerabilities in their records
To understand the role of the new version of USP <1058> for analytical instrument qualification and the role in data Integrity
Take the attendees through key stages of chromatographic processes highlighting the areas where control is required
Outline quality metrics for data integrity that could be used to monitor chromatographic analysis
Note that this course will not present or discuss basic data integrity topics such as the applicable regulations, regulatory guidance documents or the ALCOA principles.
Background
High performance liquid chromatography is a key analytical technique used in nearly all analytical laboratories in the pharmaceutical industry from analytical development to quality control. As such it is regulated with sections in all of the major pharmacopoeias (Ph.Eur., USP, etc.) and is subject of an FDA reviewer guidance document. However, HPLC and the associated CDS applications have been the source of major non-compliances involving data falsification and fraud since the Able Laboratories fraud case in 2005. Therefore, attendees will be given practical advice on ways to ensure chromatographic data integrity and carry out effective second person reviews.
This Live Online Training will deal with helping attendees understand the latest USP and DI requirements for the successful application of HPLC in a regulated GMP laboratory. 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
Target Group
This Live Online Training is intended for experienced chromatographers, HPLC laboratory supervisors, QC laboratory managers and employees in Quality Assurance.
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 trainings 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.
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.
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 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
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
This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager" Learn more
Testimonials
Seminar Programme as PDF