Why Is Inspection Preparation Needed?

PREPARATION NEEDED?

By Martin Baker

It is a good question and one that I feel was effectively answered at this year’s PIPA Conference. The session was led by Ranjana Khanna, Head of Pharmacovigilance Quality Assurance at Vifor Pharma. Ranjana has over 15 years of experience in the pharmaceutical industry and through a combination of PowerPoint slides and role-plays, she delivered an interactive and engaging session; sharing her personal experiences, learnings and some useful dos and don’ts on inspection readiness. Interestingly for me, one of the main take home messages from the session was the development opportunity an inspection could offer MI and PV professionals.

Let me try and explain.

The session opened with a recap of some of the laws and regulations that govern and drive inspections in the European Union. Then the role and responsibilities of the Inspector was described, and we were all reminded that an inspector’s job is to identify potential deficiencies in the company’s system(s) (e.g. a non-compliance which could pose a risk to the patient and/or public health), so we shouldn’t take these personally.

Ranjana then went into a good amount of detail regarding how an inspection should be conducted: general rules of engagement, timelines and a description of the flow an inspection will typically follow - as well as the right of an inspector to amend the inspection plan e.g. by adding new topics to the agenda, calling additional staff for interview and/or adjusting timelines.

The crux of the presentation rightly focused on what we can all do to effectively prepare ourselves and the company for an inspection. Ranjana shared some very useful insights that could make all the difference, for example:

• Establish a core inspection team

• Set up a Subject Matter Expert (SME) list

• Have all trainings completed prior to the first inspection day

• Be aware of current issues/potential areas of concern in your function and know if corrective measures have already commenced

• Familiarise yourself with the previous inspection findings and/or recent audit observations relevant for your function

• Have I.T. support on the day to manage any unexpected errors and to support with information sharing across different locations and time zones, if required.

Building on this understanding, the second half of the session focused around 3 role-play scenarios that were acted out. The audience where then asked to provide feedback on how well the auditee in the scenario had done at answering the inspector’s questions. The audience then appraised the quality of the responses by analysing what went wrong and sharing some tips on how the auditee could have answered the questions better. For example, some of the tips that were shared were:

• Remain professional, keep on topic and answer the questions being asked

• Be confident. If you don’t understand the question –

ask the inspector for further clarification • Sometimes a little more information is useful, ‘I think so’ answers are poor responses from a responsible person OR subject matter expert.

Ranjana closed the session and talked in detail about several key roles involved in an inspection:

• Inspection lead

• Inspection moderator • Scribe • Runner

• Document controller

She described the key attributes, qualifications and character traits people performing these duties successfully need to show.

1

Know what you do

2

Say what you do

3

Do what you say

4

Prove what you did

From a personal development opportunity, it is important to note that getting involved in an inspection could open some doors as well as increase exposure to other areas of business.

Personally, I left the session feeling much more confident with a better understanding - and appreciation of – the amount of work that goes into successfully hosting an inspection and how best to prepare yourself, your team, department and/or company.

If you have any questions or would like to receive some more information on this session, please contact me on martin.baker@alliancepharma.co.uk

Martin Baker Medical Information Manager Alliance Pharmaceuticals Ltd