Courses and Conferences for aseptic/ sterile manufacturing in the pharmaceutical industry
Within the framework of pharmaceutical production, the most demanding requirements apply to sterile manufacturing and aseptic production because this is the most critical process for the manufacture of medicinal products. Both the EU and the US (respectively in Annex 1 of the GMP Guide and the FDA Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing) have formulated very comprehensive requirements.
EU GMP Annex 1 states: „The manufacture of sterile products is subject to special requirements in order to minimize risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the personnel involved. Quality Assurance is particularly important, and this type of manufacture must strictly follow carefully established and validated methods of preparation and procedure. Sole reliance for sterility or other quality aspects must not be placed on any terminal process or finished product test“
Cleans rooms are the prerequisite for the manufacture of sterile products. They have to be established and operated according to the GMP requirements. Moreover, new systems such as isolators and RABS systems have developed processes in sterile manufacturing further. Clean rooms have thus to be classified first (in A, B, C, or D) and subsequently qualified. ISO 14644-1 defines the requirements for this procedure. Both the EU and the FDA refer to this standard in their guidelines. Nevertheless, there are differences and further requirements which have to be taken into consideration in pharmaceutical manufacturing. Comprehensive monitoring – i.e. clean room monitoring – is part of this as well as the extensive requirements regarding the personnel. Only qualified members of staff are allowed to enter the clean room. A high standard of hygiene is essential.
Concept Heidelberg regularly organises courses and conferences on sterile and aseptic manufacturing of medicinal products. Please find here a short overview:
- Risk Management for sterile manufacturing
- Environmental Monitoring - Compliant and Reasonable
- Handling Failures in Sterile Manufacturing
You can get additional qualifications thanks to our GMP Certification Programmes. We offer the following programmes: