What is Control and Quality assurance?
Every manufacturer must have a control and quality assurance system to conform to the Canadian Good Manufacturing Practices (GMP).
Quality assurance is a wide-ranging concept that covers all matters that individually or collectively influence the quality of a drug. It is the total of the organized arrangements made with the objective of ensuring that drugs are of the quality required for their intended use. Quality assurance therefore incorporates Good Manufacturing Practices, along with other factors that are outside the scope of these guidelines.
A system of quality assurance appropriate for the manufacture of drugs should ensure that:
- Drugs are designed and developed in a way that takes into account the GMP requirements;
- Managerial responsibilities are clearly specified;
- Systems, facilities and procedures are adequate;
- Production and control operations are clearly specified, and GMP are adopted;
- Arrangements are made for the supply and use of the correct raw and packaging materials;
- Control on intermediates, in-process monitoring, and validation activities are carried out;
- The finished product is processed, packaged/labelled, verified, and tested according to defined procedures;
- Drugs are not sold or supplied before the quality control department has indicated that each batch has been produced and controlled in accordance with the requirements of the marketing authorization and of any other regulations relevant to the production, control and release of drugs;
- Satisfactory arrangements exist for ensuring that the drugs are stored, distributed, and subsequently handled in such a way that quality is maintained throughout their shelf life;
- There is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system;
How are they regulated in Canada?
Title 1A, Part C of the Food and Drug Regulations defines the activities for which compliance with good manufacturing practices must be demonstrated before a site licence is granted.
Who is aimed by this regulation?
And if I don’t comply with this regulation?
Any drug must be manufactured in accordance with the Canadian GMPs under a valid site licence. If Health Canada have reasonable reasons to believe that a drug was manufactured under conditions which does not conform to the GMPs, it can requires with the manufacturer to withdraw the product of the market and also, in some cases, to suspend the site licence to the manufacturer.
What can we do for you?
Our team of experts can assist you to build a control and quality assurance system which conforms to the Canadian GMPs.
What can we do for you ? Click here
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