Annex 7 – Manufacture of Herbal Medicinal Products

Description

PIC/S Annex 7 – Manufacture of Herbal Medicinal Products

PIC/S Annex 7 and EU Annex 7 cover GMP requirements specific to the manufacture of herbal medicinal products. This course will help you understand specific requirements, from starting materials to batch documentation, for plant-based medicines (including GMP for herbal supplements as required in several jurisdictions).

Herbal medicines must be manufactured in accordance with the regulations described in the EU Annex 7 and/or PIC/S Annex 7 as well as other GMP Guides (I and II) and other requirements in Eudralex Volume 4.

EU & PIC/S Annex 7 Herbal Medicines GMP eLearning Course

What You’ll Learn:

This interactive e-Learning module introduces key GMP requirements for herbal medicines as published in Annex 7. It has additional important information for personnel working with plant-based medicines and other herbal products including herbal supplements (generally regulated as a food; but certain supplements are regulated as a pharmaceutical/drug product in several jurisdictions).

Topics in this Annex 7 GMP Compliance training course for herbal medicine manufacturers, suppliers, contractors, and GMP personnel include:

• GMP and regulatory expectations for starting materials and production documentation

• Requirements for the control, sampling, and identification of plant materials including seed selections

• Cleanliness, storage, and environmental controls essential to herbal manufacturing

• Avoiding cross-contamination and other forms of adulteration in herbal medicines

• The importance of starting material quality and consistency for herbal products

• The scope and purpose of PIC/S and EU Annex 7 for herbal medicine manufacturing

• Other important regulations and standards including the importance of adhering to biosecurity laws when sourcing herbal medicine seeds and plant materials
• Requirements for import licencing with examples from US, Australia, Canada and Europe.

Herbal Medicines – Good Manufacturing Practice (GMP)

GMP Compliance – Course Scope

The scope of this Online GMP training course on EU Annex 7 & PIC/S GMP Annex 7 applies to the manufacture of herbal medicinal products.

Due to their complex and variable nature, control of starting materials, and storage and processing will assume particular importance in the manufacture of herbal medicinal products. With additional risks inherent in manufacturing plant-based (herbal) medicines, it is crucial that all personal learn to comply with the GMP requirements in PIC/S Annex 7 or EU Annex 7, as PIC/S & EU Annexes for herbal medicines are closely aligned.

The course focuses on the importance of ensuring the quality of starting materials in the manufacture of herbal medicinal products (herbal medicines or supplements) and ensuring these are of suitable quality.

Consistent quality of the herbal substance requires detailed information of the control of its agricultural production. The selection of seeds, cultivation and harvesting conditions represent important aspects of the quality of the herbal substance and can influence the consistency of the finished product.

Key areas of emphasis include:

• The quality and traceability of starting materials such as medicinal plants, herbal substances, and herbal preparations

• The influence of seed selection, cultivation, and harvesting conditions on product consistency

• The role of agricultural practices in the overall quality of the finished product

• The GMP requirements for risk management and quality control across the product’s lifecycle.

⚠️ Please note: This course does not cover the HMPC guideline on Good Agricultural and Collection Practice for starting materials of herbal origin.

• Recommendations on an appropriate quality assurance systems and the need for supplier qualification/supplier audits (and to ensure Good Agricultural and Collection Practice is being followed by suppliers)

This Online GMP training course PIC/S Annex 7 applies to all herbal starting materials: medicinal plants, herbal substances or herbal preparations, and includes additional information on regulatory compliance such as biosecurity laws and other environmental protections.

To order, add this course to your cart. If you haven’t completed Part 1 and Part 2 of the PIC/S GMP guide, Good Recordkeeping Practice and/or other product-relevant PIC/S Annexes, consider a 4-module training bundle.  After you’ve finalised your GMP eLearning purchase, check ALL of your email folders for an email containing your login details to onlinegmptraining.com (or search for Annex 7). Access is 24/7 online, and you can begin learning within minutes of your order.

Certificate of completion for PIC/S Annex 7 (Herbal Medicines)

After successfully completing the course, you’ll receive a dated and signed Certificate of Completion, which meets general PIC/S and EU GMP regulatory expectations for GMP training records.

This Annex 7 GMP Training Certificate can be:

• Saved or printed for your records

• Attached to your resume or CV

• Added to your personnel file and GMP training program documentation

  Note: You will have access to this course for 12 months from the date of purchase. 

  One learner per licence.
  Education purposes only.