Sterile pharmaceutical preparations - injections, infusions and pharmaceutical forms for application on eyes and on mucous membranes - are expected to be efficacious and safe.
The safety includes being sterile and free from microbial toxins and visible particles. However, achieving sterility is not straightforward, requiring a series of manufacturing controls and sterilisation steps.
Assurance of sterility is obtained through an assessment of environmental controls, staff training, sterile components, environmental monitoring, and the end product sterility test. This means sterile products manufacturing itself is a continuum that stretches from development to manufacturing, to finished product, to marketing and distribution, and to utilisation of drugs and biologics.The webinars are designed to cover the critical steps, focusing on the requirements of Good Manufacturing Practice (GMP) and the essential elements needed to develop a robust sterility assurance system and contamination control strategy.
WEBINAR: EU GMP ANNEX 1 - IMPLICATIONS FOR STERILE PRODUCTS MANUFACTURE
Wednesday 1 April 2020 14:00 – 15:00 (BST)
- Understand the major updates to the latest draft of EU GMP Annex 1 for sterile products manufacture and how they differ to the current guidance
- Learn how the key changes will impact the control and release of sterile products and gain advice on how to get prepared before the regulation becomes final
- Gain an insight into the elements required for a contamination control strategy
- Become familiar with the importance of quality risk management in relation to sterile products
EXPERT WEBINAR SPEAKER
DR. TIM SANDLE
Dr. Tim Sandle has over twenty-five years’ experience of microbiological research and biopharmaceutical processing. He is a member of several editorials boards and he has written over six-hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle works for a pharmaceutical manufacturer in the UK, and is a visiting tutor at both the University of Manchester and UCL.