What is GMP in the pharmaceutical field?

Home/What is GMP in the pharmaceutical field?

What is GMP in the pharmaceutical field?

2020-08-06T17:23:42+00:00December 27th, 2018|

Good manufacturing conditions, or good maufacturing practice (GMP), in the pharma industry are designed to ensure that the pharmaceutical products are manufactured in accordance with the requirements of the factory quality system. Implementation of GMP will minimize risks associated with production processes. GMP covers all aspects of production, ranging from vendor or suppler certification, raw material acceptance and storage, cleanliness and production facility infrastructure and support systems, production equipment, employee conduct and training, and cleaning and validation processes.

In Israel, Ministry of Health audit and enforcement procedures are carried out to evaluate and enforce GMP requirements.

In the US, GMP requirements are described and enforced for drugs and medicines under 21 CFR parts 210 and 211, and for medical devices under 21 CRF 800.

In Europe, GMP requirements for drugs and medicinal products are described and enforced as part of Directive 2003/94/EC, and for medical devices under the Medical Device Directives and  the 2017 Medical Device Regulations.

 

Product Development, Delivery System & Clinical Trials

Novel cannabis products and delivery system for improved bio-availability, accuracy, consistency and efficacy that can be proven and backed up with a strong IP and clinical trials

Growing, Manufacturing & Lab Facilities Design

Conceptual & detailed design including personnel/material flow diagram, pressure cascade, cleanness level, utilities and technology based on current GxP standards and common practices

Quality Assurance & Good Practices (GxP)

An effective quality management system establishment, policies and SOPs writing, cultivation and manufacturing procedures, protocols and employees training

Cultivation & Product Manufacturing Technology

Utilities, systems, machinery and controls required for cultivation, development and manufacturing processes that will enable high quality, control and cost-effectiveness.

New Product Regulations & Submissions

Cannabis products specifications and regulatory requirements completion including all relevant documentation and data in order to be submitted and sold in regulatory markets

Qualification &Validation

New facility, infrastructure, utilities, system, machinery, software, control system, manufacturing/cleaning processes qualification and validation protocols, execution and reports

Let’s Change the Game

OUR NEWSLETTER

Subscribe to our cool newsletter.

    צור קשר