The GMP implementation programme

The implementation of a Good Manufacturing Practice programme means an improvement in your company’s productivity.

Embedding process management as well as a validated software is not an easy thing to do. Without proper planning, the project may become an obstacle for company’s operation.

For this reason, the following points need to be considered in the implementation process.

Requirements assessment and process analysis.

These two issues do not mean the same thing, but it is necessary to consider them together since process analysis is often overlooked after the requirements definition.

The IT team, with the heads of each area, should be able to draw up a basic requirements document.

The adaptability of the chosen solution is definitely important, so the main reason of many of the delays in the implementation of an efficient GMP solution is closely related to the absence of process analysis.

The customisation of the chosen solution is critical. For this reason, the cause of many of the delays in implementing an efficient GMP solution is directly related to the omission of a complete process analysis.

Companies tend not to implement this kind of programmes properly when faced with this need, and it becomes a source of many internal problems.

Finally, implementing a GMP programme aims to monitor and optimise the organisation’s current processes, through an automated system.

Selecting suitable metrics

The choice of appropriate metrics to measure the process performance is a key point.

In fact, choosing indicators that do not adequately measure the project and business objectives impacts on the solution’s effectiveness.

Documenting improvement opportunities

In order to properly identify improvement opportunities within the organisation, it is necessary to identify the problems and weaknesses of each stage of the process.

How can we achieve this?

Designing a specific worksheet for this aim, where all improvement opportunities are well registered .

Choosing the right system

The market is increasingly saturated with such solutions that are not aligned with the specific needs of each company. For this reason it is always advisable to invest in a tailor-made solution that covers all the company current needs.

All areas should be involved

The adoption of such a solution and its adaptation should be approved by the following areas:

– Heads of each area and management team; in terms of the functional and business needs to be covered.

– Staff who will be affected by the implementation of the Project

– User staff, who must consider how their day-to-day operations are affected by this new workflow.

– IT area in charge of its maintenance

Testing

The real impact of this process management can only be verified once it has been put into force, fully deployed and after successive optimisation phases have been carried out.

Although it is a long process, it is always better to test the solution progressively and in testing environments where it is clearly proven to work. In a short period of time you will see the benefits:

1)  It reduces risks and guarantees quick success.

2) Overcomes any remaining objections within the company.

3) It improves the users’ and technical managers’ learning curve.

Results analysis and process optimisation

The implementation of a GMP solution must be organised based on the added value it generates for the Business. If the system cannot measure and guarantee positive ROI, all efforts will have been in vain as further investments cannot be justified.

Set some strategic KPIs and check results of the process optimisation. Once the process has been confirmed, adopt a “continuous improvement” approach that will roadmap the achievement of higher management efficiency.

Assemble the Dream Team

The proper recruitment of the staff for the deployment of a GMP solution has a positive impact

– Select the project leader, as he/she is a key person.

– Identify team members who are already internalised with process management and have analytical skills.

Conclusion

The implementation of a GMP process enables companies to increased business value, and enhance their competitive advantage. It requires hard work and planning, but most of these efforts, if used effectively, generate important benefits within the organisation.