Why the Good Manufacturing Practice (GMP) Certification is Important
Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized Good Manufacturing Practice (GMP) standards.
GMP is a system for ensuring that products are consistently produced and controlled according to quality standards.
It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
The main quality control risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.
GMP covers all aspects of production; from the starting materials, premises and equipment, to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product.
There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.
The World Health Organization (WHO) has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, such as in the European Union, in the Association of South-East Asian Nations (ASEAN), and through the Pharmaceutical Inspection Convention.
Outdoor growing and standard greenhouse cultivation of cannabis cannot meet GMP standards since these types of growing operations cannot control for the many variables that can lead to unexpected contamination. Only fully enclosed, temperature and humidity controlled, clean-room, and hygiene-enforced facilities built to meet GMP standards can be certified.