Why You Might Need a Remediation Program

NSF remediation experts work to assist companies around the world in their remediation efforts. Some projects arise from a client identifying a risk themselves, while others are a company responding to a communication from a regulatory agency.

This article will look at why remediation projects are needed, the traits of successful programs and what you need to do to ensure success in your remediation efforts.

We will look at:

• Reasons why a GMP remediation program is needed
• Key objectives of a remediation program
• The five attributes that a successful program must have
• Typical lifecycle
• The top five root causes that make a remediation program necessary
• Top ten must do’s

Reasons why a GMP remediation program is needed

There are three main reasons why remediation programs are needed:

1. You have identified the risk yourself
2. Someone else has identified the risk for you
3. There was an awareness of the risk. However, the CAPA was not completed in time, and someone identified it as a gap in your quality management system (QMS)

If you have identified the risk yourself, you have acknowledged that your systems for quality planning are fit for purpose and that you are considering:

• ICH Q9
• That you have a GMP risk register in place
• Your internal audit program is working
• That you have effective GMP surveillance processes

If somebody else has identified the risk, you need to ask yourself why the risk was missed.

The third reason you may need a remediation program is that the target program has not been completed by its target completion date. When this happens, it is a suitable time to consider issues around resources, how they are managed and if the risk is being evaluated accurately. It might also be a simple issue of timing, where the team was working on the issue but had not yet resolved it.

Key Objectives of a Remediation Program

The principal objective of a remediation program is to maintain business continuity and facilitate confident planning for the business management team. Your remediation efforts should also ensure that your business meets its long-term goals on high-quality standards, GMP compliance, product delivery and excellent customer service.

In essence, the program must ensure that you deliver the right product to the right customer at the right cost to the right quality and GMP status.

The program also needs to minimise or avoid the risk of product misbranding, adulteration or systemic GMP non-conformances.

In cases where you must share corrective and preventive actions with regulators, you need to share the information in a credible and comprehensive way that is in keeping with the commitments you have made about completion dates.

When the program begins, there is a need to:

• Stay on mission
• Stay on schedule
• Stay on budget

And to take proportionate, risk-based interventions that are sustainable, scientific and simple for the risk you are trying to prevent.

The Five Attributes That a Successful Program Must Have

• Collaboration
• Commitment
• Communication
• Continuity
• Compliance

These five traits must be underpinned by a culture of quality: an obsessive curiosity to do things right in a more straightforward, more predictable way.

Discover more: https://www.pharmafocusasia.com/articles/why-you-might-need-a-remediation-program