GACP Audits for Herbal Medicinal Products (2 part-series: GACP basics and case studies in demarcation and auditing)

Annex 7 of the EU GMP guideline clearly states that the cultivation, harvesting and processing of herbal starting material must be carried out under GACP as early as the authorisation stage, but also throughout the entire life cycle of GMP-compliant manufacturing of herbal medicinal products. This must be proven by means of a GACP declaration by the applicant and later by the marketing authorisation holder. The initial inspection and further monitoring always require audits. 

The transitions between the requirements for starting materials and active substances are fluid in the case of herbal medicinal products and depend on the processing and manufacture of the respective plants - and therefore your existing or planned manufacturing process is decisive as to whether your authority will accept the chosen demarcation concept between GMP and GACP. 

Due to the often complex, variable nature of herbal starting materials, their control, storage and processing are of particular importance in the manufacture of herbal medicinal products.
The herbal starting material must be of an appropriate, consistent quality and free from contaminants, for which the manufacturer of the herbal medicinal product must be provided with appropriate documentation, e.g. detailed information on agricultural production. The selection of seeds, cultivation and harvesting conditions are important aspects for the quality of the starting materials. The same applies to quality assurance measures in the case of wild harvesting. 

A well-known discussion for herbal medicinal products, especially in the authorisation process, is the depth of GMP requirements in the transitional area between GACP and GMP. Individual concepts are necessary here and it is hardly possible to make generalised statements.

The webinars provide an overview of the requirements of the GACP guideline. You will also learn how to prepare, conduct and follow up GACP audits. 

The webinars are aimed at marketing authorisation holders of herbal medicinal products, importers of herbal medicinal products and active substances, manufacturers of herbal medicinal products, manufacturers of herbal active substances and wholesalers of herbal medicinal products.

Contents:

Part I: GACP basics

• Legal framework in Germany and Europe 
• Demaraction between GACP and GMP: differences and similarities 
• Review of the requirements as part of the audit 
• Regulatory aspects 

Part II: Case studies in demarcation and auditing

• Comparison of different plant parts and the different manufacturing requirements derived therefrom 
• GACP audit as a Qualified Person or quality assurance of a GMP company: expectations and reality 

Duration: approx. 90 minutes per modul
Language: English | Handout: English

...more from your speaker Ronja Loy...

Webinars allow you to conveniently attend training sessions and technical presentations from anywhere at any time. They are the perfect way to keep up to date with the latest knowledge without much effort. You are also welcome to ask the speaker questions after the webinar.

Module 1 in this series can also be booked individually. You can find them in our course calendar.

Note on contingent call-off: When booking this webinar described here, two units will be deducted per participant.

For whole teams we offer attractive special prices with special advantages or develop your own in-house training for you - please contact us.