Responding to a GMP/GDP post inspection letter
A proposed format to help prepare responses to good distribution practice (GDP)/good manufacturing practice (GMP) post inspection letters.
The format described below is not mandatory but is the preferred method for providing responses, and should help to reduce the time taken to reach a compliance decision after the inspection.
1. How to respond to different deficiency classifications
1.1 Critical deficiencies
Critical deficiencies are complex in nature and responses may take different formats, depending on the issues cited.
Specific guidance is therefore not provided, but the general principles described below for major deficiencies apply.
1.2. Major deficiencies
The post inspection letter will cite the major deficiency in black. It may include a number of examples and references such as EU GMP CX, CX.1, CX.2.
Initial site response
In your initial site response you should:
- choose a new colour for your first set of responses
- answer the deficiencies raised directly underneath, preferably on the same document provided
- state clearly what you are going to do and when you are going to do it by – provide a date in the format DD/MM/YYYY
- think about the wider (systemic) issue, including other sites in the organisation - do not just respond with a correction to the single identified point
- choose appropriate timelines that are realistic (do not give extended times for simple actions)
- consider interim actions where timelines are long due to the complexity of the solution, but operations are continued (design the interim actions to protect the patient until the longer-term action is complete)
- provide your response in an editable Word document to allow the inspector to respond (if required)
- if your response is a commitment to ‘review a system’, then state when the review will be complete and what will happen with the output of the review (the inspector may request that you provide the output)
- if you have reviewed all similar areas to find other examples of the deficiency, but you found no others, clearly state this and include a description of how you performed the system review
- not include verbose responses with information not directly relevant to the remediation actions (these type of responses are not an efficient use of the inspectors’ or the company’s time - they may return them to you without review with a request to rewrite and simplify)
- not provide evidence of what you have done, unless specifically asked to
- provide your response in an editable Word document to allow the inspector to respond (if required)
- not include hard copies - they are not required and will not be reviewed
MHRA first request for further information
If the inspector requires further information, they will choose a different colour and put the request directly below the point that they require information for.
The use of different colours for each set of responses allows each party to clearly identify which points require further response.
Second site response
The site should choose a new colour for all sets of responses and reply below the further request.
The whole record of all responses will therefore be in a single document.
Do not change previous response text when you are providing additional information or further responses.
1.3 Other deficiencies
Initial site response
Follow the same format for major deficiency responses.
1.4 Comments
Comments are not deficiencies.
Initial site response
The site should respond with a minimum of an acknowledgement of each comment, no detailed action plan is required.
2. Actions to take if you cannot meet the deficiency response commitments
You must communicate with the inspector(s) if you are going to miss a timeline commitment. This communication should take place before you go beyond the due date.
The post-inspection compliance decisions are based on the acceptance of the remediation actions and their associated timescales for completion.
You can use the interim compliance report (available on the GMP/GDP guidance page) to notify of delays to commitment completion.
A PDF version of this guidance is also available, showing a colour-coded example of how to respond to the post inspection letter.
Updates to this page
-
Added the guidance PDF as a download
-
First published.