+49 341 223 292 36

Evaluation & qualification of impurities in small molecule drug substances and products, cleaning validation, leachables and extractables (E&L)

Time & Location / Datum & Veranstaltungsort

05. & 06. 02. 2020;  BioCity Leipzig Deutscher Platz 5 D-04103 Leipzig

Target audience and Organiser

Target audience / Zielgruppen

Employees of the pharmaceutical and the medical device industry, from regulatory affairs, R&D, quality assurance, from competent authorities and consultants; in particular those responsible for authorisation, analytics (laboratory), manufacturing.

Organiser / Veranstalter

ACA-pharma concept GmbH, BioCity Leipzig, Deutscher Platz 5, Leipzig in connection with the  postgraduate study programme (PGS) „Toxicology and Environment“ of University Leipzig (TOXNETZ).

Contact / Ansprechpartner

Ms Bianca Leubner
Phone: +49  (0) 341 33 73 33 60
Fax: +49 (0) 341 33 73 33 67

Registration & Accomodation


Please register online via the contact form below or email (see contact information above).

Registration fee

The registration fee includes lunch and beverages during the seminar as well as dinner on evening of day 1. All participants receive a printed version of the presentations.

Participation on 1 Day (5th or 6th Feb 2020) 690.00 €
Participation both days (5th & 6th Feb 2020) 1,150.00 €
Participation on 1 Day (5th or 6th Feb 2020)
for participants & alumni of PGS „Toxicology & Environmental protection“
540.00 €
Participation both days (5th & 6th Feb 2020)
for participants & alumni of PGS „Toxicology & Environmental protection“
890.00 €

Accomodation / Unterkunft

The information will be available upon booking of the seminar.

Speakers / Referenten

  • Prof. Dr. Clemens Allgaier  (ACA-pharma concept GmbH, Leipzig; PGS „Toxicology and Environment“ of University Leipzig (TOXNETZ))
  • Dr. Roland Frötschl (BfArm, Bonn) (angefragt)
  • Dr. Ralph Nussbaum (SYNLAB Analytics & Services Germany GmbH, Aachen)
  • Tim Averbeck (SYNLAB Analytics & Services Germany GmbH, Aachen)
  • Dr. Dirk Freitag-Stechl (CUP LABORATORIEN DR. FREITAG GMBH, Radeberg/Sachsen)
Download Flyer & Invitation (PDF)

Main topics at a glance

Small molecule impurities

  • Overview on relevant guidelines (ICH Q3A-D, Q6A, QWP/199250/2009corr)
  • Analytical approaches of identification/quantification
  • Control of impurities (organic/inorganic impurities, residual solvents) in drug development
  • Toxicological qualification of impurities/adoption of specification limits in marketed drug products
  • Testing strategies for genotoxic impurities (testing battery: in vitro, in vivo, in silico)
  • Non-animal strategies for non genotoxic impurities (TTC, QSAR, read across, in vitro testing)

Elemental impurities

  • ICH Q3D/Q10
  • PDE derivation
  • Element classification
  • Risk assessment
  • Control strategies

Cleaning validation

  • PDE derivation of (herbal) active ingredients
  • DNEL of cleaning agents
  • Calculation of MACO
  • Braketting and worst-case rating
  • SWP/169430/2012

Extractables & Leachables

  • Regulatory background in EU and US (QWP/4359/03, BPOG‘s, USP<1663>)
  • Analytical concepts and study design
  • Extrection media and conditions
  • Analytical approaches/analytical evaluation treshhold
  • Risk assessment/tolerable exposure (SCT, TTC Concept, Cramer classification), EN-ISO 10993-17: 2009-08
Programme of our seminar

Programme of our seminar

Day 1 – Small molecule impurities
(5 February 2020, 09:30 am – 04:15 pm)

09:30 am – 10:00 am Registration & Come-together
10:00 am – 11:00 am Overview on the regulatory framework concerning impurities
Dr. Roland Frötschl, BfArM Bonn
11:00 am – 11:45 am Identification and quantification of small molecule impurities
Dr. Ralph Nussbaum, SYNLAB Analytics & Services Germany GmbH, Aachen
11:45 am – 12:30 pm Lunch break
12:30 pm – 01:15 pm Rational and control of impurities in drug substances and drug products
Dr. Roland Frötschl
01:15 pm – 02:15 pm Toxicological qualification of impurities and justification of specification limits in products that are already on the market
Prof. Dr. Clemens Allgaier, ACA-pharma concept GmbH, Leipzig
02:15 pm – 02:30 pm Coffee break & Networking
02:30 pm – 03:30 pm Genotoxic impurities and testing strategies for the assessment of genotoxicity
Dr. Roland Frötschl
03:30 pm – 04:15 pm Non-animal strategies on the qualification of non-genotoxic impurities
Prof. Dr. Clemens Allgaier
06:30 pm Dinner

Day 2 – Elemental impurities, Cleaning validation and Extractables & Leachables (E&L)
(6 February 2020, 08:30 am – 04:15 pm)

08:30 am – 10:00 am Elemental impurities (ICH Q3D): experiences, developments and strategies
Dr. Roland Frötschl
10:00 am – 10:15 am Coffee break & Networking
10:15 am – 11:30 am Application of ICH Q3D in quality control of drug substances and drug products
Dr. Dirk Freitag-Stechl, CUP LABORATORIEN DR. FREITAG GmBH, Dresden
11:30 am – 12:30 pm Lunch break
12:30 pm – 01:45 pm PDE and DNEL as threshhold values for cross contamination in cleaning validation
Prof. Dr. Clemens Allgaier
01:15 pm – 02:15 pm MACO calculation in cleaning validation
Prof. Dr. Clemens Allgaier
02:15 pm – 02:30 pm Coffee break & Networking
02:30 pm – 03:00 pm Strategies on testing of E&L in drug products and medical devices
Tim Averbeck, SYNLAB Analytics & Services Germany GmbH, Aachen
03:00 pm – 04:15 pm Strategies on toxicological evaluation of Leachables and exposure based risk assessment
Prof. Dr. Clemens Allgaier
04:15 pm Final coffee & farewell


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    Qualifizierung von Verunreinigungen in Arzneimitteln: Update 2018 16.&17.08.2018 (Organische (genotoxische) Verunreinigungen und Reinigungsvalidierung, Elemental Impurities (EI), Extractables & Leachables (E&L))
    Aktuelle Fragen zur Arzneimittelsicherheit 2017
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