Non-Sterile Products – Challenges in Manufacturing & Quality


This year, the first part of the conference track will deal with topics such as automation, statistical process control or self-inspection, and the second part will deal with cleaning validation and microbiological issues. Current and modern approaches for identifying sampling points in the non-sterile area (grid-line approach) will be presented, and topics such as risk mitigation versus microbial testing will also be discussed.



Even though the focus today is strongly on the new Annex 1 and the various sterile drugs, non-sterile drugs still represent the most common dosage form, especially tablets with a share of more than 50%. Solids in particular often represent cost-effective dosage forms. They have good stability and open up adjustable options for active ingredient release.
But the various forms of non-sterile drugs also face a number of challenges in manufacturing, quality assurance and quality control. Continuous processing, procurement of production equipment and validation issues related to manufacturing play a role as well as modern validatable purification or microbial requirements e.g. regarding modern risk assessment in bioburden or Burkholderia cepacia complex. Questions of monitoring are also of interest again and again.

Target Audience

This conference track is aimed at all persons in the field of manufacturing, quality assurance and quality control who have to deal with the problems of the non-sterile manufacture of medicinal products or their active and starting materials.

Detailed Programme

Tuesday, 19 March 2024

Fully Automated and DoE-Based Development of an Oral Solid Dosage Form
Dr Thomas Brinz, Syntegon

  • Planning of all trials using Design-of-Experiments
  • Automated execution of all experiments and analysis of the results
  • How to reach Based on the automation of all development steps a high throughput and short development time

Use and Implementation of SIXsigma and SPC (Statistical Process Control) Cp and CpK to improve our Routine Production Process throughout finding the Problems
Pranvera Apostoli, Profarma

  • Capture of CPP values as part of APR (Annual Product Review) values for 300 generics - captured for final product and process steps
  • Use of SPC, IMR and trend charts
  • Analysis of Cp and CpK values and assessment of stability
  • Root Course Analysis in Cases of Instability

Self Inspection in Non-Sterile Manufacturing
Irene Heiderich, Boehringer Ingelheim

  • Why Self Inspection - regulatory background
  • Planning a Self Inspection
  • Performing a Self Inspection

Cleaning Validation in Pharmaceutical Manufacturing Industry
Eni Bushi, Profarma

  • Regulatory requirements for cleaning validation
  • Cleaning validation program
  • Sampling procedure
  • Establishment of limits

Modern Approach for Identifying Sampling Points in the Non-Sterile Area (grid-line Approach)
Dr Marcel Goverde, MGP Consulting

  • FMEA or HACCP or Risk Assessment?
  • Can a gridline approach also be used for non-sterile areas?
  • Application in practice

Bioburden Control in Non-sterile Drug Substance and Product Manufacturing – Risk Mitigation versus Microbial Testing
Dr Tony Cundell, Microbiological Consulting

  • Pros and cons of risk mitigation or microbiological testing compiled - with view on microbial quality of pharmaceutical ingredient, formulation, manufacturing process, physicochemical properties, packaging, dosage and recipients of a drug product
  • The types of microbiological compendial tests, sampling limitation and suitability for microbial enumeration and unacceptable microorganisms
  • Case Study: The shortage of infant formula in the U.S. in 2022 due to a product recall for Cronobacter sakazakii

A Case of Burkholderia cepacia Complex in Non-Sterile Manufacturing; Challenges in Isolation, Identification and Product Recalls
Rashid Idd Kihwelo, Kairuki Pharmaceuticals

  • What is Burkholderia cepacia Complex (Bcc)
  • Taxonomy and diversity of BcBcc contamination in non-sterile manufacturing
  • Challenges in isolation, Identification and the new USP chapter <60>
  • Product recalls of non-sterile products and measures to be taken prevent Bcc contamination