New USP & FDA Approaches for HPLC

New USP & FDA Approaches for HPLC

Copenhagen, Denmark

Course No 15009


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Dr Joachim Ermer, Sanofi, Germany
Dr Manfred Fischer, SkyePharma AG, Switzerland
Dr Bob McDowall, R D McDowall Ltd., UK
Dr Christine Mladek, Boehringer Ingelheim, Germa


The purpose of this course is to provide attendees with practical information to perform and manage HPLC analyses within GMP-/FDA-regulated environments of the pharmaceutical industry. The course content includes the latest information on USP with proposed approaches on HPLC method development, validation and on-going verification and the proposed in-process revision to USP <1058> on Analytical Instrument Qualification (AIQ).
Quality by Design throughout the life of an analytical procedure is the new approach to method development and validation. The USP will be writing two new chapters <220> ad <1220> and withdrawing <1224>, <1225> and <1226>. ICH Q2(R1) is also due to be updated as a consequence. In contrast, FDA has issued a final method validation guidance based on ICH Q2(R1). Attendees will learn about the differences in the two approaches to validation.

Data falsification and fraud as a result of poor data management practices and manipulation of chromatography data system (CDS) files continues to be a major regulatory topic. It is not confined to India and China but a global issue. Data management includes generating “complete data” to comply with 21 CFR 211 but also good chromatographic integration practices – when can manual integration be performed and when can’t it? What measures should GMP regulated analytical laboratories have in place to ensure the integrity of their chromatographic data? The course will include the latest FDA and MHRA guidance on the subject.


High performance liquid chromatography is a key analytical technique used in nearly all analytical laboratories in the pharmaceutical industry. As such it is regulated with sections in all of the major pharmacopoeias (Ph.Eur., USP, etc.) as well as the subject of an FDA reviewer guidance document. However, HPLC and the associated CDS applications are also the source of some major non-compliances involving falsification and fraud. Therefore attendees will be given practical advice on ways to ensure chromatographic data integrity.

This HPLC course will deal with helping attendees understand the latest USP and FDA requirements for the successful application of HPLC in a regulated GMP laboratory.

The emphasis will be on the following issues:
QbD method development and validation including understanding and trouble-shooting problems
Analytical Target Profile (ATP) as focal point of the lifecycle approach
Sampling practices and pitfalls
Sample preparation for HPLC
Latest enforcement issues and lessons for CDS
Understanding the proposed USP <1058>
Transitioning from HPLC to UPLC
USP and EP system suitability tests
Chromatographic integration in an GMP context
Better working to avoid OOS investigations
Fast and efficient validation of a CDS
Defining and protecting CDS electronic records
Understanding the requirements for complete data, raw data and primary analytical record

It is the aim of this course to provide guidance on ways of attaining best regulatory practice (GMP, FDA, pharmacopoeias, etc.) and to address tools to increase analytical HPLC labs’ efficiency and effectiveness.

Target Group

This course is intended for experienced chromatographers, HPLC Laboratory supervisors, QC Laboratory Managers and employees in Quality Assurance.


Introduction: Overview of HPLC in a GMP Laboratory
Overview of the conference
Role of HPLC in a regulated laboratory
FDA Quality Metrics – impact on the laboratory?
FDA issues with HPLC data integrity
Quality by Design for HPLC analytical procedures -
the proposed USP updates
Overview of the proposed changes for USP <1058> on Analytical Instrument Qualification

Sampling Practices and Pitfalls for HPLC Analysis
Sampling and sampling equipment
Consequences for the analysis
Sampling areas during an inspection

Supporting Documentation for HPLC
Minimizing documentation - maintaining clarity - keep it simple
Use of electronic recording systems
Standardizing processes and procedures
Operator responsibilities and training
Servicing – internal and external provider responsibilities

Sample Preparation for HPLC / Robotic HPLC
Sample preparation techniques for HPLC
Consequences for the analysis
Validation and robustness of sample preparation
Coupling and automation of sample preparation

Quality by Design and Lifecycle Approach to Pharmaceutical Analysis
Alignment with process terminology: QbD in analytics
Defining the measurement requirements: Analytical Target Profile (ATP)
3-Stage concept of the analytical lifecycle
-Method Design and Understanding
-Method Performance Qualification
-Continued Method Performance Verification

Method Design and Understanding
ATP as the starting point for QbD-method development
Identification of critical method parameters to establish the Method Design Space
Understanding the components that make a robust assay

Translating from Traditional Chromatography to Fast Chromatography
Minimizing the changes
Maximising the advantages
Improving efficiency and productivity

Efficient and FDA-conform Investigation of Out of Specification HPLC Results
Requirements of the FDA Guidance
Efficient laboratory investigations
Reanalysing, retesting, resampling
Proactive strategies to prevent OOS results
Controls of equipment and method, data trending

Risk-based HPLC Instrument Qualification: Good
Science and Compliance
Proposed changes to USP <1058>
Difference between the proposed and current versions of <1058>
‘Fitness for purpose’ and traceability
Qualification and validation challenge – an integrated approach

Validation and Verification of HPLC Procedures
Validation according to ICH and FDA Guidelines
Identification of relevant performance parameters
Evaluation of validation results
Sensible use of statistics and validation software
Verification of compendial procedures, USP Chapter <1226>

System Suitability Requirements for HPLC according to Ph.Eur. and USP
Ph.Eur and USP monographs for chromatographic techniques
Chromatographic parameters
System suitability requirements
Adjustments of chromatographic conditions
Continued method performance verification –
Monitoring of SST data

Practical Interpretation of HPLC Chromatograms:
Ensuring Data Integrity and Quality of Results
Basics of integration
How do you judge if the chromatogram is OK?
Setting the integration parameters
System suitability for integration?

Ensuring HPLC and CDS Data Integrity
Hear and understand the ten compliance requirements for chromatography data systems and the benefits they will bring to your laboratory
Learn from the mistakes of others: Able Laboratories, Ohm Laboratories, Ranbaxy, Wockhardt and many other worthy organisations

Reference Standards for HPLC
Different types of reference standards
Requirements and how to quality a reference standard

Practical Interpretation of Electronic Records for a CDS
Defining the main electronic records for a CDS to comply with 21 CFR 11 and EU GMP Chapter 4
Additional e-records that can be created depending on your ways of working
Further e-records created depending on your HPLC equipment
Effective protection of the electronic records to meet regulatory expectations
Paper or electronic records are our raw data?

Effective Analytical Method Technology Transfer
Determining requirements
Assigning responsibilities
Secrets of successful method transfer
Standardising and harmonising the process
Regulatory issues

Risk Based Validation of a CDS including Implementing Electronic Signatures for Productivity
Understanding your working practices
Eliminating Excel from the process
Plan for electronic working including electronic signatures
Understanding the regulatory requirements for electronic signatures
Validation of the CDS: expected documentation
Case study examples of productivity gains

From Analytical Target Profile (ATP) to HPLC Assay Performance Criteria
Measurement requirements for the Quality Attribute Assay
Precision and Accuracy of the reportable result
Method selection to meet the ATP
“Translation” into HPLC Assay performance criteria

Risk Assessment for Analytical Instruments and Computerised Systems
Topics to be covered in the workshop are:
Understanding the risk assessment methodology
Facilitated discussion for a simple instrument
Workshop and discussion for more complex systems

Common Method Validation Problems and How to Troubleshoot Them
Examples from published papers
Discussion in groups:
What are the mistakes?
What are possible improvements?

HPLC System Suitability Tests

Identifying the Common Pitfalls in the Validation of a Chromatography Data System

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