08.06.2015 |

LOGFILE No. 35/2015 – GMP Inspection: Be Prepared when the Inspector Comes

GMP Inspection: Be Prepared when the Inspector Comes

by Thomas Peither

The success of GMP inspections is crucial for the business continuity of a drug manufacturer. The outcome of an inspection should not be a coincidence. You can follow clear procedures and recommendations to increase substantially the success rate. In this article I highlight some important aspects you should cover while preparing for a GMP inspection.

Licence to Make Drugs

At the end of a successful GMP inspection is a manufacturing authorization, so a positive inspection is absolutely essential for the business continuity of a drug manufacturer.

For whichever reason a GMP inspector will visit you – always be prepared. Three different inspections are possible:

  • Pre-approval inspection
  • Routine inspection
  • For cause inspection

It is important to know the reason and the expectations of an authority inspection. This will have an impact on your preparation. The focus is always different. The better you understand the agency motivation, the better you can manage the challenge. In preparing for an inspection, you should focus on the following:

  • Inspection team
  • Risk identification
  • Organisation & site
  • People

Establish an Inspection Team

It is important to have the best people on board. That does not necessarily mean the highest level or the most decorated managers. The best means to have the following people on the team:

  • Subject matter experts (SMEs) with deep understanding of the quality procedures (qualification, validation, deviation, changes, etc.)
  • SMEs with deep understanding of the manufacturing processes (manufacturing, visual inspection, packaging, etc.)
  • SMEs with deep organizational knowledge (Who is responsible for what? Who knows about …? )
  • Managers responsible for GMP compliance (quality, manufacturing, quality systems, auditing, etc.)

You have to form a leading team and the appropriate SMEs for the inspection itself (front office & back office).

Identify Risks Before the Inspector is on Site

It is always better to know the risks before the inspector observes them. For that reason, inspection preparation begins long before the effective inspection. The best course is to always be prepared. The self-inspection system should deliver an evaluation of the site compliance.

If you are not sure that the self-inspection system delivers appropriate information, you can also perform an assessment as part of the inspection preparation. Common approaches are:

  • Mock inspection
  • Internal gap analysis
  • External gap analysis

Sometimes it is a good idea to get a neutral external view of the GMP compliance, especially if you have become blind to shortcomings in company processes (after many years of employment).

Prepare the Organisation and the Site

First of all, employees need to care about the success of the organisation and site. The organisation means:

  • Policies
  • SOPs
  • Documentation (batch records, qualification and validation reports, calibration reports, etc.)
  • Organisation chart and responsibilities

Focusing on the site, you should consider:

  • Manufacturing equipment
  • Infrastructure (HVAC, water, gases, etc.)
  • Facilities (rooms, floors, ceilings, etc.)

You should make regular visits to the relevant areas at least weekly to oversee progress. Take this as an opportunity to talk to people and connect, which will boost rapport and morale.

Do not underestimate the importance of a priority list and do take the risks into consideration. First, conduct a gap analysis, rank the risks, set priorities, and develop an action plan. Don’t overlook cleanliness of the site. Set up a back office organisation weeks before the inspection will take place, and bear in mind that success is crucial for your business continuity.

Prepare Your People

The best organisation and site compliance is worthless if your people do not adhere to best practices. Take your people with you on the inspection journey, and explain why the process is important. Explain:

  • The reason for the inspection
  • The upcoming action
  • How outcomes could affect the company
  • The influence on the individual situation

Quality behaviour always makes sense – and it often begins with the behaviour of management. Sometimes individual managers ignore improvements, so it is important to get support from top management. Explain how quality is a top priority issue, crucial for business continuity.

Interactive training is key to competent performance. Focus on:

  • Real life situations, such as mock inspections
  • Presentation skills
  • How to behave during the inspection
  • Language hurdles

Remember, the better people are prepared, the better the outcome of the inspection.

Summary

You do not need to re-invent the wheel. You can learn a lot from other organisations that have already mastered inspections. Talk to industry colleagues to gain additional insight that you can share with your organisation. Focus on:

  • Compliance risks
  • Organizational compliance
  • Technology compliance
  • Behaviour and personal compliance

Be prepared for you next GMP inspection. Visit our Workshop in Dublin!

Workshop GMP Inspections in Europe:
Proven Strategies on How to Prepare
17. - 18. November 2015 in Dublin

Click here for more information and registration.

Author:

Thomas Peither
Editor in Chief
Maas & Peither AG, Schopfheim, Germany
E-mail: thomas.peither@gmp-publishing.com

Thomas Peither has +20 years of consulting experience as a GMP expert for drug manufacturers. He successfully prepared companies for authority inspections (FDA, Europe, etc.). He is a well-known speaker at conferences, workshops and seminars.

 

 
 
 

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