Quality Control and Assurance
Any manufacturer must have quality control and assurance system to comply with the good manufacturing practices (GMPs).
The quality assurance is a broad concept that covers all the aspects that influence the quality of a product. This is the sum of the measures and procedures established for the quality (safety, safety, efficacy) is maintained throughout its life until it is consumed. The quality assurance therefore comprises mainly good manufacturing practices and standard operating procedures.
The appropriate quality assurance system for product manufacturing must provide evidence that:
The product is designed and developed to reflect the GMPs requirements;
Management responsibilities are clearly defined;
Systems , facilities and procedures are adequate;
Production operations and control are clearly defined and specified , and that GMPs are put into practice;
Arrangements are made for the supply and use of raw materials and appropriate packaging material;
The control of intermediates , control during manufacture and validation activities are performed;
The finished product is processed, packaged, labeled, tested and analyzed in accordance with established procedures;
The product is not sold or shipped before a service charge of quality control has declared that each batch has been manufactured and tested in accordance with the requirements of the marketing authorization and any other regulations on production, control and distribution of the product;
Arrangements exist to ensure that the product is stored, distributed and subsequently handled so that quality is maintained throughout its shelf life;
There is a self-inspection procedure and / or verification of the quality by which we regularly evaluate the effectiveness of the quality assurance system.
How are they regulated in Canada ?
Division 1A of Part C of the Food and Drug Regulations and the Natural Health Product Regulation defines the activities for which compliance with Good Manufacturing Practices must be demonstrated before an establishment or site license is issued.
In the food industry, different type of certification or permit (ex.: fish processing establishment; food exportation)are delivered once the manufacturer/processor has demonstrated its compliance with some quality control and assurance requirements.
And if I do not comply ?
If Health Canada has reasonable justifications to believe that a product has been manufactured under conditions that fail to comply minimally with GMP and other regulations specifically applicable to the product, it may require the manufacturer to remove the product from the market and, in some cases, suspend licenses and permits of the manufacturer and to cease its activities. This may result in media coverage of the event and a history of bad reputation of this company and the products manufactured by it.