Remediation / Quality Systems Compliance

  • Overview
  • Quality Enhancement Program
  • Benefits
  • Why Work With NSF?

Regulatory inspections from authorities around the world may require pharma biotech companies to respond to specific enforcement actions. Helping you with regulatory compliance is the core of our expertise. Our team includes former U.S. FDA and UK MHRA inspectors and experts with decades of experience helping companies develop strategic plans to address enforcement actions (FDA, MHRA, Health Canada, etc.).

We have substantial experience in creating, implementing, reviewing and remediating pharmaceutical quality systems for a variety of organizations. We can provide you with sound pragmatic advice on how to respond to adverse regulatory inspection findings and build a compliant pharmaceutical quality system to avoid future problems.

We utilize a systems-based approach to compliance covering the major pharmaceutical subsystems including:

  • Quality system
  • Laboratory and material controls
  • Facilities and equipment
  • Production system
  • Packaging and labeling

Our process involves a risk-based gap assessment, development of corrective action plans and ongoing support with implementation.

What differentiates us from many of our competitors is that we focus on education and behavior at all levels to ensure a sustainable quality culture change.

Our philosophy is to work with you to build a sustainable quality system that is owned by you, enhances your business and is sustainable in the long term.

For more information about FDA and Health Canada related services in remediation and quality systems and compliance, email uspharma@nsf.org or call +1 202.822.1850.

For information on services for European and other international agencies, email pharmamail@nsf.org or call +44 1751432 999.

Quality Enhancement Program

We have developed a proprietary methodology, the quality enhancement program (QEP™), to address quality system shortcomings and strengthen a company’s overall quality management system. We’ve effectively implemented the QEP approach at a number of small, mid-size and large companies.

The QEP approach is systems-based and seeks to remediate root causes by creating workable, efficient processes to ensure compliance and adherence to best practices. Sustainable and robust, the QEP has corporate-wide applicability and achieves outstanding business results in the form of reduced waste, lower costs, less rework, fewer recalls, fewer complaints and more satisfied customers. The QEP takes a process and risk-based approach to developing a “best-fit” quality management system framework in collaboration with the client. In developing the framework, the QEP allows for the examination of roles, responsibilities and processes individually and as a team, while carefully considering the company’s organizational structure, mission and underlying culture.

Benefits

Our remediation services are based on our quality enhancement program (QEP). We will:

  • Help you construct an effective response to the regulatory agency
  • Work with you to implement robust, compliant and sustainable solutions
  • Educate your people at all levels to develop and implement a lasting quality culture to ensure continued success

Our quality management and remediation plans are trusted by pharmaceutical and biotech companies - and regulatory agencies - all over the world. Our unique blend of former regulatory agency inspectors and industry professionals ensures that you receive a thorough consultation and sound, pragmatic recommendations for improvements and remediation.

We are acknowledged as a leader in this field. Pharma and biotech companies, large and small, trust us to deliver a world-class service that assures cost-effective compliance that is tailored to the company’s needs.

Why Work With NSF?

This case study illustrates a real-world example of how working with us can help your company.

Challenge: A company had received a range of critical and major GMP deficiencies from the UK regulatory body MHRA, and was facing a referral to MHRA’s Inspection Action Group. Manufacturing had to be suspended pending a risk assessment to evaluate the effect of the non-compliances in terms of risks of product misbranding and adulteration. Shifts were cancelled, the supply chain was suspended and an urgent remediation program begun.

Solution: We started by helping with the basics like acknowledging the issues with the Agency, evaluating the error chain that led to the non-compliances and engaging in timely and thorough correspondence with the Agency. Next, we worked with the company to:

  • Look at the staff behaviors that led to the critical and major non-compliances and assess how those behaviors could be altered
  • Underpin the remediation program with a series of measured, targeted interventions in leadership and management development training, behavioral GMP, human error reduction and focus on preventing recurring variation/deviation
  • Identify and evaluate risks within the company and action programs to mitigate it

We mapped the whole range of expectations from the U.S. CFRs, the EU GMP Vol. IV guide and the ICH guidelines, and using a deep knowledge of the FDA quality systems inspection technique, we:

  • Fixed the true root causes and addressed the behavior that led to the non-compliances
  • Fixed the issues in a way that was error-proofed, sustainable and economic to the business
  • Identified other, previously unknown critical risks so the site could face further inspections with more confidence and therefore reduced risk of business discontinuity, recalls and poor yields/outputs

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