Most of you will be aware of the classes of deficiency that may be discovered during your risk based inspection, but for those who do not, here is a brief summation
• A “Critical” is deficiency which causes, or leads to a significant risk of causing a product to be harmful to a human or veterinary patient
• Or a product which could result in a harmful residue in a food producing animal.
• Alternatively a critical deficiency can be the combination of a number of major deficiencies that indicates a serious system failure.
• A “Major” is a non-critical deficiency which has caused or may cause a product not to comply with its marketing authorisation;
• or which indicates a major deviation from EU Good Distribution Practice;
• or (within EU) which indicates a major deviation from the terms and provisions of the Wholesale Dealers Authorisation;
• or which indicates a failure to carry out satisfactory procedures for distribution of medicines or (within EU) a failure of the Responsible Person to fulfil his legal duties;
• or a combination of several “other” deficiencies, none of which on their own may be major, but which may together represent a major deficiency and should be explained and reported as such.
• A deficiency which cannot be classified as either critical or major, but which indicates a departure from good distribution practice.
• “Others” can also be comments.
• (A deficiency may be “other” either because it is judged as minor, or because there is insufficient information to classify it as major or critical).
Remember; inspections are risk-based, and receiving major or critical failures to comply will shorten the time between inspectorate visits to your site, or even risk suspension of your licence.
In extreme cases the IAG (Inspection Action Group) may become involved, which can result in licence suspension, licence revocation or legal action, including custodial sentences.
It pays to be compliant, and it is your responsibility to ensure that product that passes through your portals is fit for purpose and that GDP is followed.
Concerned about an upcoming inspection? Unsure that your Quality Management System is compliant?
Please contact us for a no obligation conversation.
13 Mar 2017
24 Feb 2017