Due to Covid-19 the pharmaceutical industry faces a range of challenges, but it is vitally important that compliance with current GMP requirements is maintained.
The surveillance and enforcement methodology has been modified due to travel restrictions and social isolation.
The MHRA will not be carrying out routine site visits, their focus will be on Office-based inspections. These will involve organisations being asked to provide electronic copies of documents and other information for review off-site.
This will be supplemented with teleconferences and email to follow up on questions, concerns and findings. Where necessary, the on-site portion of routine surveillance such as manufacturing plant tours will be followed up when the restrictions are eased.
So, how should you prepare for an office-based inspection?
The simple answer is, the same as you would for a full site inspection. You will be asked to supply electronic copies of documents. It is important that this is done in a controlled manner, attention should be paid to:
- Control of documentation
- A log of all documents supplied should be made.
- The documentation should be clearly marked as a copy.
- An SOP should be in place to describe the control of documentation.
- Review document content for accuracy, if errors are found correct if possible.
- Ensure documents are approved and not beyond their review date.
- Quality of copies
- It is important to ensure the copies are legible and in a common format such as .pdf, the last thing you want is for the inspector to be wasting time trying to read poor copies.
- Use of suitable software
- If copies are to be supplied from an Electronic Document Management System (EDMS) it is important to ensure the system is validated.
Only supply what is requested but it is worth preparing associated documents (e.g. if a process validation is requested, prepare the SOP).
Answering follow-up questions should be treated the same way as during a conventional inspection i.e. honestly, openly and concisely. If this is via video or teleconferencing it is important to ensure the subject matter experts are present to avoid delays in responding to queries. Notes should be taken to ensure any follow-up requirements are captured.
It is important to note that if a significant issue is encountered an on-site inspection may take place and this can be unannounced.
J-GMP have significant experience in managing inspections and provide a variety of services in support of inspections:
- Procedure review
- Mock inspection
- Response to findings
Call us on 07774354446, or use the Contact button, for more information. We’re here to help.