A two-day training course, followed by half-day on-site visits, is organized by Quintessence Enterprises Ltd
This is a High Importance Seminar, approved and subsidised by the Human Resource Development Authority
Seminar Dates: 14&15 May 2018

Sterile manufacturing and aseptic production is the most critical process for the manufacture of medicinal products. EU Annex 1 states " 

Using the referenced documents, this course will cover regulatory philosophy, aseptic process and equipment considerations, aseptic cleanroom design and operation, differential pressure requirements, airlocks, air filtration, HVAC design considerations, and a brief introduction to barrier isolation technology.

This workshop will be an opportunity to learn / to refresh knowledge on the basics of sterile manufacturing on the first day, and to get more insight about the main requirements and associated difficulties pertaining to the successive steps for terminal sterilization processes on one hand and for the aseptic processes on the other hand. The conference includes reminders of the different sterile dosage forms, the essential requirements for general sterile products and further requirements for parenteral products that are often considered as the most GMP demanding pharmaceuticals.

The participants will be given a first compilation booklet including the main historical guidelines (FDA,  EU PIC/ S, JAPAN) on sterile products manufacturing and dated from 1976 to 2011.  

The first day, after the introduction two mini‐quiz, will be submitted to participants. The same will be passed at the end of the second day to assess their initial and end proficiency in the field of sterile manufacturing.   The participants will be given a second booklet corresponding to the revised EU‐PIC/S Annex 1 on sterile products manufacturing, draft for public consultation, published [September] 2017.     The second day will be structured on the newly revised “Annex 1: Sterile Manufacturing” issued by the European Commission and the Pharmaceutical Inspection Cooperation Scheme (EU & PIC/S).

Every chapter will be illustrated with photographs and the participants will be challenged with some fair questions about the application of the different requirements. A focus will be delivered on the changes and to the additional requirements/precisions brought to the Annex 1.  

The participants will be given a second booklet corresponding to the revised EU‐PIC/S Annex 1 on sterile products manufacturing, draft for public consultation, published [September] 2017.  

Who Should Attend

This is a two-day course for people who need to understand the technical fundamentals of aseptic processing or who are responsible for aseptic operations in a lab, pilot or commercial setting. The course is ideally suited to industrial microbiologists, scientists and engineers either with technical or managerial responsibilities in the biotechnology and pharmaceutical industries

The course will also highlight the fundamentals you need to consider and can transfer back to your workplace. 

Benefits of Attending this workshop:


  • Recognize the institutional framework applied in the European Union, America and Japan to produce sterile pharmaceutical products.
  • Distinguish the specific characteristics of different types of sterile pharmaceutical products
  • List the parameters that define aseptic processes for the production of sterile pharmaceutical products
  • Evaluate and manage the risk of sterile pharmaceutical products.
  • Separate the practices involved in the production of parenteral and non-parenteral sterile pharmaceutical products
  • Apply techniques to minimize microbial contamination of sterile pharmaceutical products
  • Distinguish the cleanliness classes of production areas and the types of air cleanup monitoring equipment. 

    About the lecturers

    M. Jean-Denis Mallet, is an industrial pharmacist graduated from the Tours University (France). He has started his career abroad working at Roussel Morocco. He came back in France where he worked for Janssen as QA and Pharmygiene as Production Director. In 1994 he joined the 1st French Agency GMP Inspection Team for five years, then he joined back the industry in Janssen-Cilag as Quality Director and then Ipsen as QA Director. In 2003 he joined the 2nd French Agency (afssaps) as the head of the GMP inspection department. Since he worked at the International Committee of the Red Cross as International Auditor. He is now Compliance Director at NNE, an engineering and consulting company sharing his activity in audits, training and expertise/ problem-solving.