Planning
Fee bearing inspections of licensed wholesale dealers are carried out to assess the degree of compliance to standards of good distribution practice and compliance with the provisions of the licence.
Inspections of wholesaler dealers (WL) are usually performed every third year. General Sales List (GSL) wholesalers are companies that trade only in over the counter medicines and are inspected as part of a rolling programme covering all sites over a six year period. Inspections may be carried out at shorter intervals for specific reasons.
Notification
Advance notice of inspection is normally given to a company, unless circumstances require that an unannounced inspection should take place. The timing of the inspection would normally be notified in writing by the inspector.
In accordance with the GDP risk based inspection process, sites will be required to complete a Compliance Report in advance of inspection. Further information and guidance can be found in our Risk-based inspections section.
Conduct
The major stages of the inspection process are:
- the introductory or opening meeting
- the detailed inspection
- the summary or closing meeting
Introductory or opening meeting
The purpose of the meeting is for the Inspector to meet with the appropriate key personnel from the company to discuss the arrangements for the inspection. The Inspector would typically confirm the nature of the business, premises and security arrangements, areas to be visited and any documentation which may be required.
Site inspection
The purpose of the site inspection is to determine the degree of conformity of the operations to requirements of good practice and to assess compliance with the terms and conditions of licences issued under the appropriate legislation or with details submitted in support of an application for a licence. The inspection will typically involve visits to goods inward, storage areas (including ambient and refrigerated), returns area, interviews with key personnel and review of stock movement and quality system documentation including product recalls. Any observations, recommendations and deficiencies noted during the inspection would normally be discussed with the company representatives at the time.
During inspections of manufacturing and wholesale operations, samples of starting materials, work in progress and finished products may be taken for testing if an Inspector considers that this might assist in the detection of quality deficiencies. Occasionally, samples may be taken when these cannot be obtained from other sources, for routine surveillance purposes.
Summary or closing meeting
The purpose of the meeting is for the Inspector to provide the company with a verbal summary of the inspection findings and to allow the company to correct at this stage any misconceptions. The Inspector would typically summarise the definition and classification of deficiencies they propose to report and the company are encouraged to give an undertaking to resolve the deficiencies and to agree a provisional timetable for corrective action. The Inspector would also describe the arrangements for the formal notification of the deficiencies to the company (the post-inspection letter) and what is expected as a response.
The choice of company representatives at the meeting is primarily for the company to decide, but should normally include the senior staff who were present during the inspection and the Responsible Person (RP).
Critical deficiency
A deficiency which is causing, or leads to a significant risk of causing either a product to be harmful to the human or veterinary patient or a product which could result in a harmful residue in a food producing animal.
or A combination of a number of major deficiencies that indicates a serious
systems failure.
Major deficiency:
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 licence;
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.
Other deficiency:
A deficiency which cannot be classified as either critical or major, but which indicates a departure from good distribution practice.
(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).
Post Inspection Letter
A post- inspection letter is sent to provide written confirmation of the deficiencies noted and reported verbally during the Closing meeting.
Depending upon the inspection findings and the response from the company during and following the inspection, the Inspector may take one of a number of actions ranging from:
- sending a letter confirming essential compliance with GDP
- recommending to Inspection Action Group (IAG) consideration for adverse licensing action against a Wholesale Dealers licence.
Referral to Inspection Action Group (IAG)
Critical findings are routinely referred to the MHRA’s Inspection Action Group (IAG). The IAG is a non-statutory, multi-disciplinary group constituted to advise the Director of Inspection, Enforcement and Standards (IE&S) Division on any recommendation for regulatory or adverse licensing action appropriate to the Division. The Group considers referrals involving serious/critical GDP deficiencies. The primary objective of IAG is to protect public health by ensuring that licensable activities in the manufacturing and distribution of medicinal products meet the required regulatory standards.
An overview of the IAG process is available below:
Inspection Action Group
(1125Kb)
Company responses
The inspected site is expected to provide a written response (by letter or email) to the post-inspection letter within the required timeframe. The response should consider the context of the deficiency within the overall quality system rather than just the specific issue identified. The inspected site is expected to provide a written response to the post-inspection letter within the required timeframe. The response should consider the context of the deficiency within the overall quality system rather than just the specific issue identified. The response should include proposals for dealing with the deficiencies, together with a timetable for their implementation. It is helpful for the response to be structured as follows:
- Restate the deficiency number and the deficiency as written below.
- State the proposed corrective action.
- State the proposed target date for the completion of the corrective action(s).
- Include any comment the company considers appropriate.
- Provide an electronic version via e-mail.
Inspection report
Once the Inspector is satisfied that any necessary remedial action has been taken or is in hand and that the site is essentially in compliance with GDP, an inspection report and close-out letter are finalised.
A summary of what to expect before, during and after an inspection can be found in the presentation below:
An inspector calls presentation from the GDP symposium, January 2008 (50Kb)
