bozoomer GMP Certification - Good Manufacturing Practice
Good Manufacturing Practices (GMP) are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, supplement products. These guidelines provide minimum requirements that a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
All guidelines follow a few basic principles:
Hygiene: Food, supplement manufacturing facility must maintain a clean and hygienic manufacturing area.
Controlled environmental conditions in order to prevent cross contamination of food, supplement product from other food, supplement or extraneous particulate matter which may render the food, supplement product unsafe for human consumption.
Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the food, supplement are validated as necessary.
Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
Operators are trained to carry out and document procedures.
Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food, supplement was as expected. Deviations are investigated and documented.
Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
The distribution of the food, supplements minimizes any risk to their quality.
A system is available for recalling any batch of food, supplement from sale or supply.
Complaints about marketed food, supplements are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective food, supplements and to prevent recurrence.
Practices are recommended with the goal of safeguarding the health of patients as well as producing good quality medicine, medical devices, or active Food, supplement products. In the United States, a food, supplement may be deemed "adulterated" if it has passed all of the specifications tests, but is found to be manufactured in a facility or condition which violates or does not comply with current good manufacturing guideline. Therefore, complying with GMP is mandatory in food, supplement manufacturing.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.