header-image

Analytical Methods for Cleaning Validation - Live Online Training

25-27 June 2024

Seminar-Nr. 21099

Referent:innen

Walid El Azab

Walid El Azab

QP Pro Services

Dr. Raphael Bar

Dr. Raphael Bar

BR Consulting

All times mentioned are CEST.

Zielsetzung

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.

Hintergrund

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.

Zielgruppe

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.  

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.

Programm

Analytical Methods for Cleaning Validation - Live Online Training

Gesamtes Programm als PDF herunterladen

Introduction Cleaning Validation and Regulatory Requirements
  • Regulations (FDA, EU, PIC/S, APIC, WHO)
  • Cleaning process
  • Life cycle of  cleaning process from development to validation
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
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
  • Methods for cleaning residues
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
HPLC, TOC and Conductivity Methods for Residues
  • HPLC procedure for residues
  • Procedure for Total Organic Carbon
  • Procedure for conductivity
  • Testing methods for cleaning agents
Roadmap of Dev 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
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
Precision of Measurement Method (incl. demonstration with examples and practices)
  • Method Repeatability
  • Intermediate Precision
  • Combined analysis of Repeatability/Intermediate Precision with One-way ANOVA
Detection and Quantitation Limits of Measurement Methods (incl. demonstration with examples and practices)
  • By ICH, EP and USP methods
  • of TOC method
  • of HPLC method
  • Visual detection Limit (VDL)
Linearity of Measurement Method (incl. demonstration with examples and practices)
  • 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
  • Range on swab and rinse samples
  • Range of analytical samples
Robustness
  • Robustness factors for sampling recovery
  • Robustness factors for measurement method
  • by DOE matrix Solvent Sampling from hoses
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

Dieses Seminar/Webinar kann nicht gebucht werden. Alternative Termine für dieses Seminar/Webinar und ähnliche Veranstaltungen finden Sie in der Übersicht nach Thema..

Für viele Seminare und Webinare gibt es auch Aufzeichnungen, die Sie jederzeit bestellen und anschauen können. Diese Aufzeichnungen finden Sie in einer themensortierten Liste.

Oder senden Sie uns Ihre Anfrage einfach über das folgende Kontaktformular.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

icon
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
icon
Weitere Termine online
Weitere Termine online nicht verfügbar
icon
Aufzeichnung nicht verfügbar

Haben Sie noch Fragen?

Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de

Frau mit Headset

Zurück

Teilnehmerstimmen - das sagen andere über unsere Seminare:

"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen.
Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.”
Christian Wagener, WAGENER & CO. GmbH
GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023

„Interessante Themen, gut vorgetragen, die eigenen Erfahrungen der Vortragenden helfen, dies noch besser nachzuvollziehen.“ „Gute Gestaltung der Workshops, das Zusammenarbeiten in Gruppen und der Austausch mit anderen hilft sehr.“
Manuela Seibert, Merck, GMP-Leadauditor/in (FA 2), April 2024

NEWSLETTER

Bleiben Sie informiert mit dem GMP Newsletter von Concept Heidelberg!

GMP Newsletter

Concept Heidelberg bietet verschieden GMP Newsletter die Sie auf Ihren Bedarf hin zusammenstellen können.

Hier können Sie sich kostenfrei registrieren.

Kontakt

Kontaktieren Sie uns

Haben Sie Fragen?

Concept Heidelberg GmbH
Rischerstraße 8
69123 Heidelberg

Tel. :+49622184440
Fax : +49 6221 84 44 84
E-Mail: info@concept-heidelberg.de

zum Kontaktformular