GMP/FDA Compliance in Analytical Laboratories How to implement cGMP requirements in the everyday practice of quality control laboratories

GMP/FDA Compliance in Analytical Laboratories

Barcelona, Spain

Course No 21253

This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager". Learn more.



ECA-Member*: EUR 2090,--
Non ECA Member*: EUR 2290,--
EU/GMP Inspectorates*: EUR 1145,--
APIC Member Discount*: EUR 2190,--

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Dr Joachim Ermer, Ermer Quality Consulting, Germany
Dr Manfred Fischer, Manfred Fischer Consulting, Germany
Joerg Kastenschmidt, Merck, Germany
Dr Bob McDowall, R D McDowall Limited, UK


The purpose of this three-day education course is to give participants a comprehensive overview of FDA’s current compliance requirements (21 CFR Part 211, Guidances for Industry, Compliance Program Guide, etc.) and expectations in these and related areas, and how they can be managed effectively.

The format allows each of our speakers to give an overview of the specific regulatory requirements associated with their topic prior to describing the approach to managing the issues with respect to philosophy, documented procedures, SOPs, etc.

In addition, the programme includes four workshop sessions covering:
  • Method Validation
  • Out of Specification Results
  • Validation of Excel Spreadsheets
  • Method Transfer
The course will also discuss the implication of new developments resulting from recent FDA and USP initiatives, such as analytical lifecycle management with continuous monitoring, data integrity, ….


A major consequence of the Barr Ruling in 1993 was the significantly greater emphasis FDA inspections placed on the management and performance of quality control laboratories particularly the handling of Out of Specification results.

As a result of the increased and on-going scrutiny of analytical performance it is hardly surprising that even today the most frequently cited cGMP non-compliances are still found in laboratories, particularly:
  • General cGMP understanding and particularly relating to compliance with written procedures
  • Validation, performance and transfer of analytical procedures
  • Data integrity
  • Management of out of specification and suspect test results
  • Instrument qualification including an explanation of the new version of USP <1058>and calibration
  • Computer validation (including the requirements and actual interpretation of 21 CFR Part 11)
  • Operator training
  • Management of reagents and standards
Take advantage of this course to discuss all these issues.

Target Group

This course will be of significant value to:
  • All quality control managers responsible for FDA compliance in their laboratories
  • Senior laboratory staff charged with meeting these requirements day-to-day
  • All support staff involved in FDA inspections in their companies


General Aspects: Regulatory Requirements and FDA-Inspections
  • Regulatory Overview (US, Europe and the world)
  • Regulatory requirements in the US (cGMP, CFR, Guidances for Industry, etc.)
  • FDA Inspections
  • Key issues during laboratory inspections
  • 483s and Warning Letters
Qualification of Analytical Instruments in QC Laboratories
  • Legal requirements (cGMP, CFR, etc.)
  • USP General Chapter <1058> Analytical Instrument Qualification
  • Qualification Phases (DQ/IQ/OQ/PQ)
  • Qualification examples (problems and solutions)
  • Analytical instrument life-cycle (Requalification, etc.)
Calibration for FDA Inspected Analytical Laboratories
  • General approach to Calibration
  • Instrument calibration in the USP
  • Contrasting US and European approaches (important in the context of laboratories struggling to meet both requirements)
Reference Standards and Reagents for FDA-Inspected Laboratories
  • Regulatory requirements
  • Types of reference standards: Official/primary/working standards/reference materials
  • Traceability, characterisation, and retest date of standards
  • Risk-based approach for management, storage and shelf-life of laboratory reagents and solutions
  • Stability investigation of solutions for quantitation
Validation of Analytical Procedures
  • Regulatory requirements (ICH, FDA, compendia)
  • Lifecycle approach (3-Stage-Model according to USP General Chapter <1220>)
  • Verification of compendial procedures
  • Rationale design of validation studies
  • Identification of relevant performance parameters
  • Sensible use of statistics
  • Suitable performance parameters for continuous monitoring
Stability Testing
  • Regulatory requirements for stability testing of drug substances and drug products
  • Types of stability studies
  • Storage conditions requirements according to climatic zones
  • Stability protocol and reports
  • Establishment of storage conditions and shelf-life
  • Stability testing for post-approval changes
Out of Specification Results
  • Requirements of the FDA Guidance
  • Efficient laboratory investigations
  • Reanalysing, retesting, resampling
  • Management of variability-caused OOS results
  • Investigation of atypical results
  • Proactive strategies to prevent OOS results
Documentation for Quality Control Laboratories
  • “Scientifically sound” GMP requirements of QC documents and approaches
  • Types of QC laboratory documents:
    - Test specifications and analytical procedures
    - Standard Operating Procedures
    - Instrument qualification protocols
    - Complete data for analytical testing and Certificates of Analysis
  • Compare and contrast FDA and EU documentation requirements
  • Management of blank forms and data integrity issues
Sampling in Compliance with FDA Requirements
  • Importance of the sampling procedure
  • Regulatory requirements
  • Sampling statistics / sampling plans
  • Sampling procedures
  • Sampling equipment and environment
  • Training
  • Retained samples
Practical Computer Validation in Analytical Laboratories
  • Computerised system validation as a critical activity in the analytical laboratory
  • 21 CFR Part 11 compliance
  • FDA emphasis on data integrity for computerised systems
  • GAMP software categories and impact on validation approach
  • GAMP Good Practice Guide for Validation of Laboratory Systems second edition
  • Case study examples: how to validate systems in a cost-effective way and steps of what not to do!
FDA Approaches to Laboratory Data Integrity
  • FDA laboratory observations: falsification and fraud
  • Compliance Program Guide 7346.832 on Pre-Approval Inspections: Objective 3 - Laboratory data integrity
  • FDA inspector training: focus on the computer system not paper printouts
  • What controls do you need to have in place to ensure data integrity?
Four Workshops
Some of the most important laboratory compliance topics will be further discussed in interactive workshops:

Topic I: Method Validation

Topic II: Out of Specification Results

Topic III: Validation of Excel Spreadsheets
Moderator: Dr BOB McDOWALL

Topic IV: Method Transfer

Transfer of Analytical Procedures
  • USP General Chapter <1224>Transfer of Analytical Procedures (TAP)
  • Key steps for a successful method transfer:
    - Initiation phase (training method familiarization, etc.)
    - Types of Transfer
    - Analytical procedures
    - Materials (samples and standards) and testing design
    - Instruments
    - Data assessment – Acceptance criteria
    - Documentation (transfer protocol/report)
  • Summary
Validation of Excel Spreadsheets
  • Excel spreadsheets are used widely in analytical laboratories as it is easily available and easy to use - and equally so, it is easy to misuse
  • Technical features available in Excel
  • Practical ways to validate Excel spreadsheets
  • Protection of the electronic records produced
  • Problems of complying with 21 CFR Part 11 and the new EU GMP Annex 11 Requirements
Training Case Study
  • Legal requirements
  • Education/GMP-training/Training on the job
  • Training records
  • Re-training frequency

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