GACP CERTIFICATION

The GACP certification (“Good Cultivation and Harvesting Practices for Medicinal Plants”) is the normative reference for the general technical indications needed to obtain good quality medicinal plant materials for the sustainable production of medicines.

The World Health Organisation (WHO) standards provide detailed descriptions of the techniques and measures required for the appropriate cultivation and harvesting of medicinal plants and for the collection and recording of data and information about the operations performed.

The safety and quality of raw materials derived from medicinal plants and finished products depends on internal factors (genetic) or external factors (environment, procedures, processing, transport, storage).

Quality control therefore has a direct influence on the safety and efficacy of medicinal plant products. Practices are only the first step in quality assurance, on which product safety and efficacy depend.

GACP certification represents the standard requirement to qualify material for initial entry into the pharmaceutical industry and to qualify your company as a supplier.

Through the compliance with the standards defined in the standard, “Good Agricultural and Collecting Practices”, you will be able to pursue the following objectives:

• Credibility, reliability, transparency towards the external market;
• Continuous improvement of performance and possibility of cost reduction;
• Satisfaction of market requirements and facilitation of exports;
• Guarantee of quality, safety and consolidation of the corporate identity.

The certification path consists of 4 stages

Application for Certification

In this first part the economic aspects and the activities that will be performed by the auditors during the certification activity are agreed. It ends with the signing of a contract. The certification process is in fact a contract between the company and the certification body. It usually lasts three years.

Preliminary Audit (optional and possibly requested by the customer)

Its purpose is to examine the level of preparedness of the system being certified. This type of audit is not part of the certification process, so any improvements are issued in the form of a recommendation and are not officially notified in the audit report.

Certification Audit – Stage 1

The audit takes place at the company’s premises. During this stage, the auditor collects information and checks the certification documentation. He determines which are the mandatory and voluntary reference standards for the system to be certified. This step is preparatory to the second certification audit.

Certification Audit – Stage 2

During this stage the auditor will check that the standards are actually being applied by the company. At the end of this stage, the Certification Body may proceed with the certification decision.