EMA: Update of the GACP Guideline Published

The guideline on Good Agricultural and Collection Practice (GACP) for herbal starting materials has been in place since 2006 to ensure consistent quality of herbal substances. The newly released Revision 1 updates the document to current standards, reflecting developments over the past decade such as the growing use of indoor cultivation technologies and published legal interpretations. In addition, Annex 1 introduces specific requirements for indoor cultivation practices.

Indoor cultivation facilities should contain adequate systems for air, climate and humidity control, light, water treatment, ventilation and air filtration systems. They are designed to:

• Control access to personnel;
• Minimise potential contamination;
• Facilitate cleaning, maintenance and other operations;
• Be impermeable to cleaning and disinfecting agents.

For documentation, the new Annex 1 stipulates:

• Documentation of all relevant conditions, materials, and processes
• Batch-specific acceptance criteria for cultivation & production
• SOP-based document management including retention rules
• Product specifications per batch defined and recorded
• Cleaning activities documented in batch records/logbooks
• Daily digital records of critical process parameters for indoor cultivation

Regarding crop maintenance and plant protection, Annex 1 stipulates:

• Written procedures for material receipt, storage, handling, sampling, approval/rejection
• Validation of processes, cleaning, and responsibilities documented
• Calibration of all cultivation equipment per schedule
• Material approval before each new cultivation cycle by QA
• Indoor cultivation: Identify critical quality attributes (CQA) & process parameters (CPP)
• Define in-process criteria and controls
• Standardize cultivation process
• Complete qualification of critical equipment and supporting systems

Source:

EMA: Good agricultural and collection practice for starting materials of herbal origin - Scientific guideline