The Three Signs That 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

NSF's team of ex-regulators and industry experts have a global reputation for excellence in remediation projects. When companies embark on a remediation project, they need to get it right first time and get back to full operations. NSF's expert team helps companies do that time and again. If you would like to have an initial chat with us about a possible remediation issue or project, please contact us using the link at the end of this article.

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.

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 minimize 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.

• 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.

A culture of quality will ensure that a company has more effective collaboration and a commitment to doing things properly in a timely manner. Getting there requires a simple communication plan that ensures that the right people are ‘looped in’ and ‘on mission.’ These are not one-off interventions or interactions and can often be undertaken on receipts of a warning letter from a regulatory authority (such as the FDA or the MHRA). They can often be long-term projects that can last between 12 and 24 months, so the issue of continuity is critical to the program's success.

Leaders of these programs must consider how to maintain enthusiasm, work rate and focus to deliver within the agreed timeframes. Everything must be in keeping with GMP regulations, directives and cGMP expectations to the connecting observation or issue. In this instance, there is no substitute for expertise in compliance.

A typical remediation program has as many as eight stages within its lifecycle. They can be divided equally into two sections: the state of shock and the act of doing. The eight stages are:

1. Discovery
2. Disbelief, denial and anger
3. Stasis
4. Acceptance
5. Evaluation
6. Planning
7. Execution of actions
8. Effectiveness checks

What many companies forget is the importance of effectiveness checks. How do you know that what you have done works? One typical way to ensure that your work is effective and that mistakes/issues do not repeat themselves is to define what success will look like at the start. Doing so will help you to avoid corrective and preventative actions in the future. Defining success at the start of the exercise also ensures you spend your budget and resources in the right areas.

Many companies have a form of remediation program linked to their training and education program. At NSF, we use a simple cycle of planning called EDGE: evaluation, diagnosis, guidance and checks for effectiveness. It is a cyclical process you can utilize at any point, depending on where you are in your program. EDGE looks at:

• Quality planning
• Appraisal, audit and risk assessment
• Risk mitigation and CAPA
• Simplification and business effectiveness

EDGE aims to bring a company to a state of perpetual readiness.

It is a tool that leverages NSF’s unique offerings across:

• Science
  • Technical training program
• Compliance
  • Quality and GMP training program
  • Establishing and sustaining the quality management system
  • Audit and regulatory inspections
  • GMP remediation

• Leadership
  • Quality culture
  • Management behavior
  • Risk-based decision making
  • Human error reduction
  • Moving towards business excellence through management of quality costs
  • Business engineering with companies, including start-ups

1. Inadequate foresight of what the future will demand of the business
2. Ineffective management of resources and knowledge
3. Staff turnover and a lack of investment in the education and coaching of leaders and subject matter experts
4. Inadequate identification, evaluation and mitigation of risk
5. Inadequate quality management system

1. Preparation and proactive measures are critical
2. Be prepared for this to take time.
3. Remember that there is no substitute for the technical knowledge of the cGMPs.
4. Do only what is needed, sustainable and effective in maintaining GMP compliance.
5. Bring your staff with you.
6. Use the exercise to strengthen and simplify your team.
7. Make commitments that are specific, measurable, action-oriented, realistic and targeted.
8. Keep to your commitment.
9. Keep meticulous records of what was done and what was improved.
10. Ensure accountability through excellent project management skills.

The expert team at NSF has a track record of developing and delivering successful remediation programs for companies worldwide.

Get in touch with us today if you would like our assistance with your GMP remediation program.