Analytical Methods for Cleaning Validation - Live Online Training
Development, Validation & Control
9-11 June 2026
Course No. 22506
With outlook on ICH Q2(R2) and ICH Q14
Target Group
The addressees of the event are analytical chemists testing the residues, quality control personnel, quality assurance personnel, regulatory affairs professionals, GMP auditors and inspectors and validation personnel also involved in cleaning Validation.
Objectives
This live online training consists of two parts. The first part revolves around the development of suitable analytical methods. The characteristics of these methods (HPLC, HPTLC, TOC, conductometry, pH, total protein, visual inspection, etc.) will be discussed in the light of their capability of detection and quantitation of residues. In particular, the advantages of the TOC method in accurately detecting and quantifying low levels of nonspecific residues (such as detergents, drug excipients and active ingredients) which may not be determined by HPLC, will be highlighted. Prior to this, the concept of Maximal Carry Over (MAC) limits according to PIC/S, FDA and WHO guides will be presented along with the new EMA approach based on toxicity thresholds. Finally, a pre-requisite requirement for a well-developed analytical procedure is an efficient sampling recovery and therefore, the first part of the course will highlight the various techniques of sampling recovery.
The second part of the live online training will address a systematic validation of the analytical method for cleaning residues. Performance characteristics of the analytical method (accuracy, precision, linearity, robustness, sensitivity and sampling recovery) will be systematically presented.
This Live Online Training combines presentations and practices with Excel, which allows all delegates to apply the presented theory directly into practice. Therefore, a device with installed Excel programme is required.
Background
Initiating a manufacturing of pharmaceutical in shared equipment requires demonstrating that no cross-contamination from previous product takes place. Optimally, residues from previous manufactured product or API or residues from the cleaning agent itself should be absent or very low. The validation of any cleaning process relies heavily on the validity of the test results provided by the analytical procedure for cleaning residues. However, here lies the challenge facing an analytical chemist: the need to develop and validate an analytical method that is sensitive enough to detect and reliably quantify well recovered trace amounts of chemicals and practical enough to rapidly deliver results.
Programme
Cleaning Method Characteristics
Types of cleaning residues and their identification
Analytical methods for cleaning residues: specific versus non-specific (HPLC, HPTLC, TOC, Conductometry, pH, total protein, visual inspection etc…)
Methods for validation and for Monitoring
Limit test versus quantitative test
Correlation between specific and non-specific Methods for cleaning residues
Introduction Cleaning Validation and Regulatory Requirements
Regulations (FDA, EU, PIC/S, APIC, WHO)
Cleaning process
Life cycle of cleaning process from development to validation
HPLC, TOC and Conductivity Methods for Residues
HPLC procedure for residues
Procedure for Total Organic Carbon
Procedure for conductivity
Testing methods for cleaning agents
Understanding the Allowable Carryover (MAC)
Common MAC limits (PIC/S, FDA and WHO guides)
New approach of EMA guide (NOAEL and PDE)
Residues limits on swab and rinse samples and in analytical samples
Formulas for calculating MAC
Sampling Techniques of Cleaning Residues
Swab and Wipe Sampling
Requirements from Swab
Rinse Sampling
Solvent Sampling
Placebo Sampling
Product Sampling
Visual examination of cleaned equipment
Roadmap of Development and Validation of Analytical Procedure of Cleaning Residues
Cleanability studies
Development of an analytical method for residues
Requirements from a method ready for Validation
Validation strategy of analytical methods for residues
Role of statistical tools in method Validation
Overview of the roadmap from development to formal validation of analytical procedures
The approach to development and validation of analytical procedures according to the new draft ICH Q14 and Q2(R2) guides
Specificity of Measurement Method
Interference with excipient residues, degradation product, and cleaning residue
Interference with swab extractables
Interferences in analytical samples
Quantitative aspect of specificity
Precision of Measurement Method (incl. demonstration)
Method Repeatability
Intermediate Precision
Combined analysis of Repeatability/Intermediate
Precision with One-way ANOVA
Accuracy (incl. demonstration with examples and practices)
Swab Recovery Studies on coupons
Rinse Recovery Studies on coupons
Solvent Sampling from hoses
Accuracy of the Measurement Method
Detection and Quantitation Limits of Measurement Methods (incl. demonstration)
By ICH, EP and USP methods
of TOC method
of HPLC method
Visual detection Limit (VDL)
Robustness
Robustness factors for sampling recovery
Robustness factors for measurement method
by DOE matrix Solvent Sampling from hoses
Linearity and Range of Measurement Method(incl. demonstration)
ICH requirements (Correlation coefficient, residual SS, residuals plot)
Considerations (number of data points, of repeats, quality of fit to linearity, etc.)
Analysis of plot of measured vs. actual concentrations
Correlation between Cleaning Validation and Monitoring: Relative TOC response factor of Target Residue/
Reference Standard in TOC method
Range on swab and rinse samples
Range of analytical samples
Validation of Sampling Recovery
Validation of swab and rinse sampling recovery
What Spiking levels?
How many replicates?
Acceptance criteria
Should you correct for recovery?
Validation of Visible Residue Level (VRL)
Examples of statistical recovery data analysis
Documentation of Method Validation
Writing a protocol
Writing a report
Further Information
Technical Requirements We use Webex for our live online training courses and webinars. At 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.
Conference language The official conference language will be English.
Fees (per delegate, plus VAT) ECA Members € 2,290 APIC Members € 2,390 Non-ECA Members € 2,490 EU GMP Inspectorates € 1,245 The conference 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.
Testimonials
