Pharmaceutical Audits

  • Overview
  • Training
  • Why Work With NSF?

Pressure on the pharmaceutical industry to audit has never been higher and continues to increase. Supply chain and batch release decisions are being made based on audits and self-inspections. Our team of expert pharmaceutical auditors 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, software, water systems, autoclaves, raw material suppliers and many other vendor and supplier services.

At NSF, we can audit any type of activity against all major international regulatory and GMP standards, including EU, USA, Canada, Australia, WHO and more. Rather than simply telling you where you fail to comply, we provide essential, pragmatic advice on how to achieve compliance in a cost-effective way. We also work with you to ensure that remedial action plans are comprehensive, effectively implemented and, where appropriate, fully documented.

NSF's auditing team can offer services specific to your needs, including:

  • Compliance consulting: We provide 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.
  • Regulatory consulting: We offer specialist advice on target product profiles, regulatory strategy, orphan drugs and unique and combination products (due diligence, regulatory pathways).
  • Mock regulatory inspections: We help you prepare for a regulatory inspection by carrying out mock regulatory audits in advance of the real thing. Consultants visit your facility and carry out an inspection in the style of the relevant regulatory body (FDA, MHRA, EMEA, etc.).
  • Due diligence audits: We assist pharmaceutical companies, investment banks and venture capital organizations in the process of due diligence for potential acquisitions, buy-ins, joint ventures and other investment projects.
  • Benchmarking audits: We assess your facilities, procedures and practices against current industry norms, based on our exposure to pharmaceutical companies, large and small, worldwide.

Training

In addition to providing auditing services, we also provide auditor training.

Given the regulatory pressure on the pharma industry, a high level of scrutiny is being placed on the training and development of auditors and self-inspectors . We responded by redesigning and reintroducing an existing course with a qualification for pharmaceutical group lead auditors. The course is certified by IRCA (the International Register of Certificated Auditors), the world’s largest certification body for auditors of quality management systems, and meets the requirements of the FDA Pharmaceutical Quality Management System.

Our auditor course has been specifically designed to provide attendees 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. With content and delivery of EudraLex Volume 4, Chapters 1 to 9 and ICH Q10 as the combined QMS, this is the first truly certified GMP auditor training course available globally today.

Other auditor training course topics include:

  • Steriles
  • Pharmaceutical microbiology (QP4)
  • Formulation and processing (QP3)
  • Quality management systems (QP8)
  • Biotech

If you are already familiar with the subject matter, but want to explore, consider these:

  • Standards
  • Industry norms and best practices
  • Designing audit plans
  • Evaluating observations
  • Personal Q&A and tutoring

Why Work With NSF?

Meeting your auditing needs

We appreciate the enormous breadth of knowledge that is required to conduct pharmaceutical audits. It is a job that requires a range of skills related to organization, report writing, vendor management and timekeeping. The auditor is also expected to know all about each dosage form, the CFRs and EudraLex, from clinical manufacture to distribution.

NSF's pharma audit staff has been in your shoes. We understand. We work with industry experts who have the appropriate range of skills and constantly seek to fit the right person to the job. In addition to providing a vast range of auditing capabilities, NSF can offer in-depth, IRCA accredited auditor training from the experts. Topics include:

  • Steriles
  • Pharmaceutical microbiology (QP4)
  • Formulation and processing (QP3)
  • Quality management systems (QP8)
  • Biotech

If you are already familiar with the subject matter, but want to explore, consider these:

  • Standards
  • Industry norms and best practices
  • Designing audit plans
  • Evaluating observations
  • Personal Q&A and tutoring

Related to Pharmaceutical Audits

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  • “A lot better understanding of ICH Q10! Overall understanding of auditing process is now a lot better. This course indicated clearly on which areas I personally need to improve.” Paivi Waris / Santen Oy, Finland
  • “An excellent course with well-presented material by highly knowledgeable tutors. The opportunity to take part in a mock audit closing meeting was extremely valuable.” Matthew Scarff / Rosemont Pharmaceuticals Ltd, UK
  • “The chance to learn from very experienced tutors is very, very, valuable! Excellent experience.” Richard Anspach / Aluglas BV, The Netherlands

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