Contact us

Case Study: What Happens When An MIA Is Suspended?

NSF supported a UK-based pharmaceutical manufacturer to address issues that resulted in an MIA suspension. This case study outlines our work to help restore the MIA, returning the client to full manufacturing.

The possibility of having a Manufacturer's and Importer's Authorization (MIA) suspended strikes fear into the hearts of pharmaceutical executives everywhere. License suspensions can have considerable consequences for the security of the company’s workforce. It can cause reputational damage and have an impact on revenue.

In this case study, we examine a client NSF supported to address the significant issues that resulted in an MIA suspension and outline how we helped bring them back to full manufacturing.

We look at:

  • The powers held by regulators in Europe.
  • What happens when a regulator finds critical or numerous major findings.
  • The findings identified at the company.
  • How NSF worked with the company.
  • Lessons learned.

What Powers Do Regulators Have?

European regulators have the power to suspend, vary or evoke an MIA from a company if the regulator identifies critical or major findings during an audit1.

To ensure compliance, MIA license holders must:

  • Establish and implement an effective pharmaceutical quality assurance system.
  • Have competent and appropriately qualified personnel sufficient in number to achieve the pharmaceutical quality objective(s).
  • Define the duties of managerial and supervisory staff responsible for implementing and operating GMP in their job descriptions.
  • Give personnel sufficient authority and training to meet the pharmaceutical quality objective(s).
  • Institute and maintain hygiene programs relating to health, hygiene and clothing.
  • Provide and maintain premises and equipment appropriate to the intended operations.
  • Have system(s) of documentation covering all the processes and specifications covering the various operations. Batch documentation must be retained for at least one year after the expiry date of the batch to which it relates.
  • Provide and maintain an independent quality control department under the authority of the person nominated as responsible for overall quality control.
  • Retain records and samples of starting materials and finished products for the required periods.
  • Ensure that any work contracted out is the subject of a written contract.
  • Maintain an effective system whereby complaints are reviewed and products may be recalled.
  • Carry out a program of regular self-inspection.

How Long Does It Take a Regulator to Act?

Regulatory inspectors who identify critical or numerous findings can move swiftly to issue a suspension, although the timing does depend on the seriousness of the findings and the risk to patients. Manufacturing must cease as soon as a suspension of an MIA is issued unless it is a partial suspension. Furthermore, the suspended MIA license is listed on the EUDRAGMP database and other regulatory authorities are informed. Suspension can last for a considerable period, often for months.

Case Study

NSF was called to work with a UK-based pharmaceutical manufacturer following the suspension of their MIA by the UK regulator, the Medicines and Healthcare Products Regulatory Authority (MHRA).

A GMP inspection of the site had found:

  1. Poor investigations, including not looking broadly enough at other batches that may be implicated.
  2. Control strategies that did not prevent cross-contamination.
  3. Evidence of inadequate cleaning of equipment and facilities.
  4. Facilities and equipment of poor design, construction and maintenance.
  5. Inadequate management of supplier qualification, approval and maintenance of API suppliers.

What Happened Next

Initially, the company began responding to inspection findings. However, it quickly became evident that they did not have the expertise required to manage a project of this scale. The company’s management engaged NSF to manage the project and help the manufacturing site resume operations with MIA reinstatement.

What NSF Did

NSF worked over 18 months to bring the site back into compliance and, importantly, helped provide continuity to the company as staff turnover was high during that time. NSF handled multiple elements of this complex project, including:

Response Management

  • Developed and wrote responses to inspections
  • Carried out a risk assessment of products on the market
  • Completed a risk assessment of products within the company’s control
  • Prepared update sessions for the regulatory authority, including securing approval of quality metrics
  • Presented progress reports to regulatory authorities
  • Participated in management review meetings
  • Project managed all actions, including the setting of priorities
  • Recruited key staff, including the new quality director

Quality Assurance and Documentation Issues Management

  • Assessed the completeness of CAPA closures
  • Developed supplier quality management processes, including excipient assessment procedures
  • Implemented improvements to batch manufacturing instructions
  • Developed a contamination control strategy
  • Improved the pharmaceutical quality system (PQS) elements, including assessment procedures
  • Wrote and approved validation reports, including IQ, OQ, PQ, and analytical/cleaning

Comprehensive Training Plan Implementation

  • Developed a training strategy to include eLearning and in-person training specifically for the site
  • Delivered training to all board members, management and members of staff

Other Aspects

  • Consulted on issues such as computer systems validation, data integrity, engineering processes and maintenance systems
  • Developed an occupational health policy

How We Succeeded

During this significant undertaking, NSF experts worked to bring the site back to manufacturing and to secure the company’s MIA reinstatement.

The company’s license was reinstated after 12 months, and they could supply products from the site six months later. In total, the company could not supply products from the site for 18 months.

Lessons Learned

NSF’s multi-disciplinary team spent a significant period working with the company to remediate the issues and reinstate the MIA license. When asked about lessons learned and observations from the project, our experts identified five key takeaways:

  1. Early involvement can ensure a proportionate, timely and systematic response. If you believe that your site is being referred to the licensing authority, or if voluntary or official action is indicated, seek assistance from NSF immediately.
  2. Always ensure that corrective and preventive actions are treated as a project. Have a dedicated project manager to ensure that risks are flagged early.
  3. Subject matter experts can save time by developing pragmatic and compliant solutions.
  4. Staff needs to know what happened and the role they can play to help in MIA remediation.
  5. Trusted independent experts can act as a sounding board for staff during this time. Companies should never underestimate the variety of emotions that their team will experience.

We Can Help

In this instance, the company was aware that they were not prepared or capable of effectively managing the issue at an early stage. They called on NSF’s expert team to guide them through a lengthy process, ensuring the reinstatement of their MIA. The NSF multi-disciplinary team has put the company and its staff on a secure footing, ready to supply their products to market.

NSF can help your company prevent issues like this from happening, or, if the worst happens, we can work with your company to get your MIA reinstated. Contact us today by using the form below.

Ready to Begin the Process?

Contact us with questions or to receive a quote.

NSF was instrumental in ensuring our turnaround plan met all the regulator’s concerns. NSF was our trusted advisor during an exceptionally difficult period. They provided board-level input on strategy whilst deploying technical experts with sometimes very short notice to cover gaps in competence or expertise internally.
CEO of UK-based Pharma Manufacturer

News and Events

NSF Health Sciences Podcasts – Access Expert Content On-the-Go
October 22, 2020
Access a wealth of free podcasts and webinar recordings from our pharma and medical devices experts to help you make better business decisions and stay up to date with the latest industry trends. These podcasts include interviews, Q&A sessions, consolidated white papers, webinars and more. These short podcasts are perfect for when you’re on the road or need information quickly. Our experts in the pharma and medical device industry cover topics like: Drug shortages and the impact on global health careCommunication methods that create stability and direction while being authentic and trustworthyMaintaining the product disposition process underpinning the supply chainData integrityCheck back for our latest podcast and follow NSF Health Sciences on Spotify and Apple Podcasts to stay in the know!
Read the Story
NSF’s Responsible Person Course Is Now MHRA Recognized and Cogent Gold Standard Approved
August 27, 2019
We are very pleased to announce that NSF’s Responsible Person and Good Distribution Practice course now meets the Cogent Gold Standard competencies for the role of the RP in Medicinal Products and the accompanying standard. Catherine Kay, Director of NSF’s Pharmaceutical Services who led the process alongside tutor Sam Clack, said “We underwent a rigorous process to get all of our course materials mapped against the Gold Standard in record time, with only one review cycle by Cogent and the Medicines and Healthcare products Regulatory Agency. This was a great indicator that our course content was of a high standard, covering all necessary requirements, including a session on the role of the Responsible Person (import). The RPi is required to implement a system for confirming QP certification has taken place when importing medicines from the EEA into the UK.” About the Course This highly interactive three-day course focuses on the key requirements for the distribution and storage of pharmaceutical products and materials, providing you with the practical skills to effectively implement these principles at your own facility, as well as carry out the role of the RP. Upon completion of our Gold Standard RP and GDP course, delegates will receive an MHRA-recognized Cogent Skills certificate, reflecting the national standard to which they have been trained. The course is taking place 8-10 October 2019. You can learn more about the course and book your place online. About the Cogent Skills Gold Standard Cogent Skills alongside the MHRA developed a new Gold Standard role profile for a Responsible Person in Medicinal Products, which in turn has led to the agreement of a training standard which is recognized by the MHRA. The Responsible Person Gold Standard sets out an industry-agreed framework that identifies the skills required by a Responsible Person in four skills areas: Technical Compliance Business improvement Functional and behavioral This spread of skills ensures that the role includes not only the traditional qualifications and technical requirements but also the behavioral skills required to do the job to a high standard. These include business improvement, leadership and communication. The training standard shows what good training entails to meet the Gold Standard competencies which NSF’s GDP and RP training incorporates. Find out more about our comprehensive range of support services.
Read the Story
NSF Updates Pharma App
March 21, 2019
NSF announces new updates for its pharma app, available on Apple’s App Store and Android’s Google Play. It now includes pharmaceutical training information and allows users to book and pay for our courses including eLearning sessions while on the go. This free app is also full of useful resources right at your fingertips and is perfect for the pharma biotech professional. NSF’s pharma app has several easy-to-navigate sections including: Resources Looking for information from management controls to quality systems and everything in between? Look no further. Our resources section has all the latest thought leadership you’re looking for. Everything from white papers to webinars and videos to check lists, FAQs and more in just a few clicks. Legislation and Guidance Stay up to date on the latest industry regulations and news, along with access to our Legislation and Guidance guide. Be in the know! Self-Assessment Company Quizzes Get a snapshot of your company’s health with our self-assessment quizzes. Do you have gaps in your quality systems? Take the quiz and find out. Check back often as we are always adding new quizzes. What’s New Just like the name says, this section has the latest industry news that affects your business. Training You can access our range of training information and book our courses. Ask an Expert Have an urgent question or need quick advice from an expert with 20+ years of pharma biotech industry knowledge? We have you covered with our Ask an Expert feature. With one click, you can ask a question to one of our many NSF industry experts and receive a response within 48 hours. We could keep listing all the benefits of this app, but we want you to stop reading and experience it for yourself by downloading the app today. Simply enter “NSF pharma” on your phone in your app search field or select a link below: Apple App Store | Google Play If you run into any issues, contact us at - we’re here to help!
Read the Story


1Medicines and Healthcare Products Regulatory Authority (MHRA), Notes for Applicants and Holders of a Manufacturer’s Licence, MHRA Guidance Note 5, available at (2014).

How NSF Can Help You

Get in touch to find out how we can help you and your business thrive.

What’s New with NSF