Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have. GMP, along with Good Agricultural Practices (GAP), Good Laboratory Practices(GLP) and Good Clinical Practices (GCP), are overseen by regulatory agencies in the United States, Canada, Europe, China, and other countries.
All of our suppliers in China have been certified with the GMP for pharmaceutical products by the State Food & Drug Administration of China, which assures that:
• Products are designed and developed in a way that takes account of the requirements of GMP.
• Production and quality control operations are in compliance with GMP.
• Managerial responsibilities are clearly specified.
• Arrangements are made for the purchase and use of the correct starting and packaging materials.
• All necessary controls on intermediate products are effectively carried out.
• Qualifications and validations are carried out.
• Products are correctly processed, checked, tested, and verified, according to the defined procedures.
• Each batch of products is not released before the approval of the Qualified Person.
• Satisfactory arrangements exist to ensure that the products are stored, distributed and subsequently handled.
• Self-inspection is regularly carried out to appraise the effectiveness and applicability of the Quality Assurance system, according to the procedures.
cGMP refers to the current GMP guidelines set forth by the United States Food and Drug Administration (FDA). The "c" in cGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations.
cGMP is a very detailed and complete system, and addresses all of the following areas:
• The grounds surrounding the production facility and the materials used in its construction;
• The production and testing equipment;
• Personnel and training;
• Sanitation and hygiene;
• Air and water purification;
• The environmental conditions for both storage and manufacturing;
• The manufacturing process;
• The receiving and testing of all raw components;
• In-process product testing for identity, purity, strength and composition;
• Documentation for all stages of the receiving, testing and manufacturing process;
• The traceability of all ingredients and components used in each batch.
When applying for export permission, an herbal manufacturer in China must provide documents containing the results of screening tests for heavy metals, pesticide residues, moisture and bacteria as requested by an importing company in the USA. If any ingredient of a herbal product does not meet the testing requirements, then appropriate permissions will not be granted and thereby, the herbal product cannot be sent to the United States. When an herbal product arrives at the US border, it must go through customs and quarantine processes including the inspections by various of US government agencies.
Good Agricultural Practices are "practices that address environmental, economic and social sustainability for on-farm processes, and result in safe and quality food and non-food agricultural products" (FAO COAG 2003 GAP paper). The objective of these GAP codes, standards and regulations include, to a varying degree:
• Ensuring safety and quality of produce in the food chain
• Capturing new market advantages by modifying supply chain governance
• Improving natural resources use, workers health and working conditions, and/or
• Creating new market opportunities for farmers and exporters in developing countries.