The need for compliance with cGMP guidelines is that the set standard for quality assurance helps in offering safe and effective health products and medicines to the consumers. The main role of medicines such as tablets, capsules, health care products and supplements is to meet the requirement of its intended use.
Whether one is putting up a capsule manufacturing plant or encapsulation unit, tablet manufacturing unit or any other contract manufacturing plant, it needs to be approved by the main regulatory body. The compliance with current Good Manufacturing Practices help in the procurement of a license for carrying out manufacturing work at a unit.
A licensed facility is approved by the health regulatory bodies and similar national or regional authorities. Such a facility and its processes, methodology and operation complies with the guidelines laid down by the GMP or good manufacturing practices of a region or a country. These guidelines may vary from region to region and can have different specifications depending on the laws of Health and Public welfare divisions of the government.
The Health Canada has specific cGMP guidelines that need to be complied by and certain specifications fulfilled by the manufacturing units in the region. In order to carry out manufacturing processes in these units, Health Canada issues licenses for the contract manufacturers certifying that their activities are as per the Establishment licensing framework.
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