Health Products and Food Branch Inspectorate of Canada has issued the guidelines on Risk Classification of Good Manufacturing Practices (GMP) Observations referred to as GUI-0023.
The scope of these guidelines is to classify the observations noted during establishment inspections according to their risk. It calls to ensure uniformity among the inspectors of the Health Products and Food Branch Inspectorate in the attribution of the rating following inspections. Besides it also informs the industry of the situations that the Inspectorate considers unacceptable and that will generate a Non-Compliant (NC) rating following an inspection.
During an establishment inspection, deviations from the Food and Drug Regulations and the current edition of the GMP guidelines 2009 Version 2 GUI 0001 were noted by the inspector and these deviations appear as observations in the inspection Exit Notice. A judgement based on these observations was made by the inspector and an overall recommendation was given.
These covered Compliant which is at the time of the inspection, the regulated party has demonstrated that the activities it conducts are in compliance with the Food and Drugs Act and its associated Regulations. Yet a ‘C’ rating does not mean that there are no observations or corrective actions required.
Non-Compliant or NC rating is provided if the regulated party has not demonstrated compliance with the Food and Drugs Act and its associated regulations. Attribution of a NC rating may have serious consequences for a company, ranging from the implementation of important corrective measures to the temporary suspension or termination of the Establishment License (EL), stated Health Canada.
The definition of a drug in Canada covers a wide variety of products including pharmaceuticals and biologics products. This guidance document covers these products to which Division 2 of Part C of the Food and Drug Regulations applies and is based on the current edition of the GMP.
It is recognized that the evaluation of the conformity to the GMP should be commensurate with the risk involved taking into account the nature and extent of the deviation in relation with the category of products evaluated. Nonetheless, most of the situations involving fraud, misrepresentation or falsification of products or data will generate a NC rating, irrespective of the category of products involved, said the regulatory authority.
It is impossible to encompass every situation that may generate a risk, but the industry should ensure that the risk assigned on the nature and number of occurrences. Generally, when only low risk products are involved, a risk 1 will not be assigned to observations except for extreme situations like fraud or widespread cross-contamination, infestation or unsanitary conditions.
Where a risk 2 observation is re-evaluated as a risk 1, this situation is immediately brought to the attention of the company’s officials. The industry will need to provide proper explanation which should be captured in the Inspection Reporting System (IRS).
A NC rating may also be assigned in situations when numerous Risk 2 observations are noted. Repetition of many Risk 2 and Risk 3 observations noted during previous inspections indicate that the company did not put in place adequate preventive actions in a timely manner to avoid recurrence of such deviations. Generally, a C rating is assigned when Risk 2 observations are noted and in all situations where only Risk 3 observations are noted during an inspection.
When a NC rating is assigned, the inspector will issue a draft inspection Exit Notice during the exit meeting.
Source:Pharmabiz
The scope of these guidelines is to classify the observations noted during establishment inspections according to their risk. It calls to ensure uniformity among the inspectors of the Health Products and Food Branch Inspectorate in the attribution of the rating following inspections. Besides it also informs the industry of the situations that the Inspectorate considers unacceptable and that will generate a Non-Compliant (NC) rating following an inspection.
During an establishment inspection, deviations from the Food and Drug Regulations and the current edition of the GMP guidelines 2009 Version 2 GUI 0001 were noted by the inspector and these deviations appear as observations in the inspection Exit Notice. A judgement based on these observations was made by the inspector and an overall recommendation was given.
These covered Compliant which is at the time of the inspection, the regulated party has demonstrated that the activities it conducts are in compliance with the Food and Drugs Act and its associated Regulations. Yet a ‘C’ rating does not mean that there are no observations or corrective actions required.
Non-Compliant or NC rating is provided if the regulated party has not demonstrated compliance with the Food and Drugs Act and its associated regulations. Attribution of a NC rating may have serious consequences for a company, ranging from the implementation of important corrective measures to the temporary suspension or termination of the Establishment License (EL), stated Health Canada.
The definition of a drug in Canada covers a wide variety of products including pharmaceuticals and biologics products. This guidance document covers these products to which Division 2 of Part C of the Food and Drug Regulations applies and is based on the current edition of the GMP.
It is recognized that the evaluation of the conformity to the GMP should be commensurate with the risk involved taking into account the nature and extent of the deviation in relation with the category of products evaluated. Nonetheless, most of the situations involving fraud, misrepresentation or falsification of products or data will generate a NC rating, irrespective of the category of products involved, said the regulatory authority.
It is impossible to encompass every situation that may generate a risk, but the industry should ensure that the risk assigned on the nature and number of occurrences. Generally, when only low risk products are involved, a risk 1 will not be assigned to observations except for extreme situations like fraud or widespread cross-contamination, infestation or unsanitary conditions.
Where a risk 2 observation is re-evaluated as a risk 1, this situation is immediately brought to the attention of the company’s officials. The industry will need to provide proper explanation which should be captured in the Inspection Reporting System (IRS).
A NC rating may also be assigned in situations when numerous Risk 2 observations are noted. Repetition of many Risk 2 and Risk 3 observations noted during previous inspections indicate that the company did not put in place adequate preventive actions in a timely manner to avoid recurrence of such deviations. Generally, a C rating is assigned when Risk 2 observations are noted and in all situations where only Risk 3 observations are noted during an inspection.
When a NC rating is assigned, the inspector will issue a draft inspection Exit Notice during the exit meeting.
Source:Pharmabiz
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