The Q7 guideline of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) is considered the global standard for the broad field of manufacturing all types of active ingredients for human medicines.
The document describes the GMP requirements that apply to the manufacture of APIs (active pharmaceutical ingredients). Particularly with regard to international supply chains, the application of ICH Q7 ensures that comparable quality requirements are pursued regardless of the country of origin.
The ECA Europeam Compliance Academy offers a comprehensive seminar from 25 to 28 November 2025 on ICH Q7 as part of its training courses. Speakers from industry, practice, and regulatory authorities impart the necessary basic knowledge about the requirements of ICH Q7. Two parallel courses are available, depending on the type of manufacturing: chemical synthesis or cell culture/fermentation.
gempex supports the event. Tim Ohlrich, Manager GMP Compliance Projects, contributes his experience in dealing with the regulations in the course "ICH Q7 Compliance for the Manufacture of Active Ingredients by Chemical Synthesis" with the following technical lectures:
Equipment Qualification and Calibration
- Regulatory requirements – guidelines
- Validation project: validation master plan, risk analysis, DQ, IQ, OQ, PQ
- Practical approaches to equipment qualification and calibration
- How to handle „legacy equipment”
- Documentation (validation plan and protocols, validation reports, revalidation)
Engineering and Equipment Design
- Good Engineering Practices
- Buildings, equipment
- Flow of materials
- Requirements for utilities
- Water quality in API manufacte
- Containment
With his extensive practical expertise, Tim Ohlrich explains the various options available for GMP-compliant implementation. Close cooperation with engineering (GEP, Good Engineering Practices) is always the key to efficient qualification. If the requirements to be tested later in the qualification process are considered during planning, valuable savings potential could be achieved.
All information about the event is available on the website of the organizer, ECA Academy, www.gmp-compliance.org, under course number 21919.
One of gempex's particular strengths is its ability to efficiently implement qualification in a wide variety of scenarios.
If you have any questions about efficient equipment qualification and GEP Good Engineering Practice, please contact Tim Ohlrich at contact@gempex.com.
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Qualification: DQ, IQ, OQ, PQ