Manufacture of sterile pharmaceutical products by aseptic processing and terminal sterilization

Manufacture of sterile pharmaceutical products training course

14 – 15 November 2019

Kiev

Course Objectives
  • To understand the mechanisms of contamination transfer from source to product and the protective measures in place to prevent product contamination
  • To have the opportunity to work with risk management techniques
  • To understand the key control measures and they impact the sterility assurance of the product
  • To introduce new thinking for qualification & validation based on risk assessment
  • To follow the EU GMP and cGMP regulations and guidelines for aseptic processing and to engage in discussions regarding industry changes and best practices

Target group
Anyone who wants to know more about GMP, such as quality control, quality assurance, and operations staff who perform GMP activities

Workshop program:

14.11.2019
10:00 – 11:15	Terms and definitions Requirements for the production of sterile drugs How to choose the sterilization method Organization of production of liquid, sterile medicines: in aseptic conditions and with the use of finishing thermal sterilization. GMP requirements and practical implementation of the process: • solution preparation • cooling water for injection, • dispensing and loading of active pharmaceutical ingredients and excipients, • mixing, • sterilizing filtration, • filling the primary packaging.
11:30 – 13:00	Wash of primary packaging. Qualification of the car washer of primary packing. Dry-heat sterilization and deproteinization. Qualification of the Depirogenation Tunnel. Qualification of the depirogenation tunnel.
13:00 – 14:00	Lunch break
14:00 –17:00	Wet heat sterilization Sterilization with superheated water Monitoring of bioburden Qualification and re-qualification of steam sterilizer Data integrity on the production of sterile medicines

15.11.2019
10:00 – 13:00	Validation of the sterilizing filtration: • regulatory requirements for sterilization • risk analysis during validation of the filtration process • study of the viability of microorganisms • bacterial retention • chemical compatibility • adsorption • extractables and leachables • product-wetted integrity testing • toxicity testing
13:00 – 14:00	Lunch break
14:00 – 15:30	Intervention risk analysis Qualification and validation as a tool to reduce the risks of drug non-sterility Validation of Aseptic Processes (MFT) Restricted Access Barrier Systems & Isolator
15:40 – 17:00	Practical workshops

Previous training

Trainings archive

Next training