The ICH Q7 Guideline is par excellence THE set of rules for the manufacture of chemically synthesized or fermentatively produced Active Pharmaceutical Ingredients, APIs. The guideline was recommended for use by the regulatory authorities of the European Union, Japan and the USA as early as November 2000, following a public consultation by the responsible ICH expert group. Since then, it has also been consistently implemented in the industry.
The ECA-Training Course 2023 ICH Q7, June 19-23, Munich, provides detailed knowledge of all the requirements outlined and gives practical advice on how to implement them. Important questions such as:
- at which process step GMP compliance has to be applied,
- how to deal with process validation, equipment qualification, deviation management,
- how a risk-based approach can be integrated,
- how suppliers of starting materials should be qualified
are discussed and explained with examples.
On the way to becoming an auditor
The course leads to a certificate of attendance, which then entitles the participant to take part in the subsequent auditor training course and, if passed, to be considered a certified ECA QA manager and auditor for Active Pharmaceutical Ingredient Manufacturing in the future. The auditor training course provides instruction in "Good Audit Practice". Communication aspects as well as cultural conditions are addressed.
Equipment qualification and calibration
Ralf Gengenbach, Managing Director gempex GmbH, will present the important basics for equipment qualification and calibration in the session ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis. This includes the presentation of the regulatory requirements as well as the existing guidelines for their implementation. A complete validation project is then presented in detail, starting with the validation master plan, through the risk analysis to the design qualification, the installation qualification, the operational qualification and the performance qualification. All the fundamentals are explained using practical examples, and the treatment of Equipment that has been in operation for many years, often referred to as Old Equipment (Legacy Equipment), is also discussed in detail. The lecture will be rounded off with information on redundancy-free documentation.
Further information as well as the possibility of the registration are made available with the organizer, the ECA.
The gempex expert team will be happy to assist you in the area of equipment qualification via contact@gempex.com.
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Qualification: DQ, IQ, OQ, PQ