27
August 2020

Webinar - Pharmaceutical Forensics: Solving Contamination Issues (FPM) in Pharmaceutical and Healthcare Sectors

Location:

Online webinar

During this webinar, you will hear from our industry expert on best practices for investigating FPM and contamination related issues using forensic analysis. Several case studies will be presented to demonstrate the approaches taken to identify and determine the root cause of contamination.

 

Our industry expert, Fatma Salahioglu (PhD, CSci) will be discussing:

• Regulatory expectations and industry best practices
• Use of forensic methods to determine identity and source of contamination
• Prevention of product recalls and process improvement

Several case studies will be presented to demonstrate the approaches taken to identify and determine the root cause of contamination.

Followed by a live Q&A with our expert.

Date: Thursday 27th August 2020

Time: 3pm BST

Foreign Particulate Matter (FPM) is still an issue despite all measures and controls even in regulated environments such as the pharmaceutical and biopharmaceutical industries. It is crucial to control the presence of such contamination, because this not only affects the end users by impacting on product quality and safety, but also has significant consequences on the manufacturer leading to loss of batches, product recalls and regulatory action.

Historically, regulatory guidance on particulate matter has focused solely on the size and number of particles present. Over the past several years, however, we began to see more and more of the regulators expecting the manufacturers to further characterise and understand the particles encountered by performing testing to identify and determine their root cause.

Presence of FPM in a product indicates potential problems at certain stages of manufacture, assembly or the packaging processes. Identification of FPM is the first step in determining the root cause of the problem.

We offer world class particle counting and particle characterisation service:

Particle Counting

  • USP <788> Particulate Matter in Injections
  • USP <789> Particulate Matter in Ophthalmic Solutions
  • USP <790> Visible particulates in Injection
  • USP <1788> Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions

Techniques

  • Sample isolation and preparation - ISO14644 Class 5 standard (FS 209 Class 100) laminar flow cabinets minimising sample contamination
  • Light obscuration single particle counter - Size
  • Optical microscopy with image analysis – Size, Shape, Colour

This is the first in a series of webinars where we will be showcasing our Impurity and Contamination Centre of Excellence.

Please visit our Foreign Particulate Matter Testing page or contact us at pharma@lgcgroup.com to find out more.