Consultancy, Regulatory Compliance and Auditing

GMP Compliance

We can perform an in-depth audit of your operations, or those of a third party, to assess current levels of compliance with international GxP regulations and expectations.

We don’t just tell you where you fail to comply, we provide essential, pragmatic advice on how to achieve regulatory compliance in a a cost-effective way. Additionally, we will work with you to ensure that remedial action plans are comprehensive, are effectively implemented and where appropriate, fully documented.

We partner with you to add value to your business!

EU and FDA Inspection Readiness

We have extensive experience of preparing companies throughout the world for MHRA or other EU regulatory inspections and our success rate is enviable.

Perhaps more surprising is our excellent record of preparing European clients for FDA inspections. We offer many advantages over US-based consultancies in this respect:

• We are totally familiar with FDA regulations and expectations during inspections because of our extensive work with US-based clients
• We have practical experience of how the FDA carries out overseas inspections, whereas many US consultancies have experience only of domestic investigations, which are very different both in duration and focus
• We have strong cultural links to Europe, but we also share a common language with the USA and we understand the US mentality which allows us to bridge the gap between European and US philosophies
• We are based in Europe, so the cost of using our services is lower than using US-based consultancies, and we are more accessible for support in the final preparation phases

Mock Regulatory Inspections

We regularly assist clients to prepare for an imminent regulatory inspection by carrying out one or more mock regulatory audits in advance of the real thing.

Our pharmaceutical consultants will visit your facility and carry out an inspection in the style of the relevant regulatory body (FDA, MHRA, EMEA etc.) after which we provide:

• An in-depth, impartial and professional assessment of their current state of compliance

• A detailed, prioritised action plan for the rectification of areas of noncompliance and vulnerability

• Staff coaching in the sorts of questions which are likely to be asked during the inspection and how best to answer them

• Sound, practical support and advice in the run-up to the real inspection

Troubleshooting and Problem Solving

When you are very close to a problem it can become difficult to solve. Our team has considerable expertise with helping companies to systematically resolve problems associated with their products, processes, equipment and systems.

Understanding the root cause and reducing Human Error is essential to deviation reduction and the elimination of repeat deviations. Our team has supported numerous projects helping our customers to achieve this.

Rx-360

It is unreasonable to expect vendors to accommodate audits from all their customers at times to suit their customers. And even if they could, they cannot possibly respond positively to the diverse and sometimes contradictory requests made by all those customers. Again, this is where the third party experts can help. The organisation, Rx-360, which is discussed elsewhere in this Journal, was created to provide pharmaceutical manufacturers with the technical resource to perform an in-depth audit of suppliers and then to provide a report which can be used by Rx-360’s membership. This satisfies the need to have confidence in the quality standards of the supplier without subjecting the supplier to a deluge of supplier audits from different companies with very different levels of experience and competence.

NSF Health Sciences is proud to be an approved auditor for Rx-360.

Third Party Audits

We can assist you in your search for the ideal contractor by performing audits on your behalf to any GMP standard for: Production - Packing - Testing - Storage and distribution - Engineering - Computer software - Water Systems - Autoclaves - Raw material suppliers - A range of other vendor and supplier services

We will provide you with a detailed, balanced report highlighting: Company strengths - Company vulnerabilities - Recommendations for short, medium and long term remedial actions - Our overall recommendations as to the suitability of the contractor for your needs

There are numerous advantages to using NSF Health Sciences for this work: We have the necessary expertise - We can compare what we find with what we know is available elsewhere - The third party is more likely to be open with an independent group than with the potential client and there are fewer concerns regarding confidentiality.

Supplier Audits

We can perform audits of your suppliers and contractors worldwide. We regularly perform compliance audits of contract manufacturers, contract laboratories, API manufacturers, producers of exipients and many other service providers.

Our audits are focussed on your products and/or services and give you the confidence that your contractors are in compliance with the appropriate GMP standards and, more importantly, that those services which are specific to you are under control.

We are an Rx360 approved auditing company, we have worked closely with IPEC to develop standards for assessment of exipient producers and we have developed a global protocol for the assessment of OTC medicines and prescription drug manufacturers.

Whatever your needs, we have the expertise and the global reach to help you.

Benchmarking Audits

Our constant exposure to pharmaceutical companies, large and small, on a worldwide basis allows us to be able to assess your facilities, procedures and practices against current industry norms.

We can help you to assess your position in the marketplace and can provide sound, common sense advice on how to move forward.

Due Diligence Audits

We regularly assist pharmaceutical companies, investment banks and venture capital organisations in the process of due diligence for potential acquisitions, buy-ins, joint ventures and other investment projects.

We perform an in-depth assessment of the regulatory compliance status of companies and/or projects by reviewing:

• The status of marketing approvals, applications etc
• Current complaints, adverse reactions etc in order to assess vulnerability
• Current relationships with the major regulatory authorities
• The quality of staff in key technical positions
• The general levels of GMP compliance and investment needed to maintain GMP compliance in the short, medium and long term

Training to be an Auditor

Bringing Added Value With An IRCA Certified Training Course

Pressure on the pharmaceutical industry to audit has never been higher and continues to increase. Supply chain decisions and batch release decisions are being made based on audits and self-inspections. As a result, a high level of scrutiny is being placed on the training and development of auditors and self-inspectors.

Faced with industry and regulatory pressure, NSF Health Sciences was actively encouraged to successfully redesign an existing, popular course and reintroduce it with a new qualification for pharmaceutical group lead auditors. The course, certified by IRCA (www.irca.org), the world’s largest international certification body for auditors of quality management systems, meets the requirements of the new Pharmaceutical Quality Management System.

The course has been specifically designed to provide delegates with education, training and development to meet today’s pharmaceutical pressures, including the auditor skills and toolbox of auditing techniques needed by the successful pharmaceutical lead auditor. Given the course focus, content and delivery of EudraLex Volume 4 Chapters 1 to 9, ICH Q10 as the combined QMS, the team at NSF Health Sciences sees this as the first truly certified GMP auditor training course available globally today.

How to Audit Courses

At NSF Health Sciences we appreciate the enormous breadth of knowledge that is required to be a pharmaceutical auditor. It is a job that requires a range of skills related to organisation, report writing, managing vendors and time keeping. Add to this the fact that within the pharmaceutical arena the auditor is expected to know all about each dosage form and the CFRs and EudraLex inside out, from Clinical Manufacture to Distribution and beyond.

We know the challenges because here at NSF Health Sciences, through our contract auditing services, we are fortunate enough to work with a group of industry experts who have the appropriate range of skills; we are continually working to fit the right person to the job, to enable us to produce the standard of work the client expects. We believe that this same group of experts can help you to develop your auditing skills and product knowledge, so we have put together a series of ‘How to Audit’ courses that will help you perform your audits with the correct understanding of the topic and the regulatory expectations relating to that topic.
Here are the courses we have in our current schedule:

IRCA

“Quality management systems audit is a professional activity and, as with any profession, requires individuals to have the necessary knowledge and skills, and to deploy the required behaviours to deliver value:

• Value for the stakeholders who rely on management systems audit to establish if the organisation has the capability to consistently meet customer and applicable regulatory requirements.
• Value for the auditee by providing management with information regarding the organisation’s ability to meet its quality related business objectives; identifying problems that may prevent the client from meeting its quality related business objectives; and identifying meaningful opportunities for improvement and areas of risk that are not identified or managed.

IRCA approved training organisations, such as NSF Health Sciences, play a key role in setting auditors off on their journey to delivering this value by providing training and examination against international audit and quality management standards. Post training, IRCA PQMS lead auditor certification provides the professional framework for auditors to gain audit experience, working within a professional code of conduct and committing to on-going maintenance and development of their knowledge and skills. Developing a cadre of professional PQMS lead auditors will help ultimately support confidence that our sector is dealing with the industry changes and increasing regulatory pressures.”

Vincent Desmond
IRCA Deputy Director

Useful Documents

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