Is it Time to Outsource Internal Auditing?
By Mike Levitt
As I discussed at the recent 47th annual International GMP Conference in Athens, Georgia recently, the objective of internal auditing is to self-identify opportunities for improvement. For the quality side of operations, the goal is to ensure the quality systems are properly designed and functioning as intended. Recently I have been asked by senior leaders in some organizations, “If I have an internal auditing team and procedure, why am I still receiving observations during regulatory audits?” The answer is complex and depends on both the internal environment of the company and the external business environment in which it is operating.
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The fundamentals for having an effective internal auditing program really haven’t changed since the practice was developed in the early 1940’s as companies rapidly grew to meet the production demands for materials during the second world war. It begins with senior leadership being committed to quality and compliance, prioritizing remediation of any findings. It requires a program with clear objectives and procedures designed to assess and correct, if necessary, any aspects of the quality system that may compromise product quality or regulatory compliance. Finally, a successful program requires auditors who have the technical expertise to objectively evaluate the system coupled with the skills to communicate effectively up and down the organization what changes are required. Without all these factors in place, a company’s internal auditing program quickly becomes a bureaucratic exercise consuming significant resources but yielding little benefit.
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In today’s pharmaceutical manufacturing industry, changes both in rapidly advancing technologies and in the general work culture, are driving the need to alter our approach to internal auditing. The rapid growth of biopharmaceuticals coupled with the accelerating trend to utilize third parties to manufacture clinical and commercial material are redefining what ‘internal auditing’ needs to achieve. Further, the changing work culture of many new and smaller start-up companies populated by less experienced staff with much higher turnover rates than seen when only large multinational pharmaceutical companies dominated the development and manufacturing of medicines is undermining the effectiveness of internal auditing to help ensure self-regulation of quality and compliance.
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Just as the incredible advances we are seeing in new therapies and vaccines to treat and cure diseases is requiring innovative, ‘out of the box’ thinking, the approach to internal auditing needs to be redefined and approached in ways that allow the process to help achieve quality and compliance in this very different landscape. In this environment with companies having limited internal resources and outsourcing manufacturing to third parties, should we follow the same path developed more than 80 years ago? Or should companies turn to third party resources to provide objective subject matter experts to periodically conduct audits covering internal quality systems and the quality/compliance relationship with external manufacturing partners? Recent FDA inspection data shows that the major observational trends have not changed significantly in the last 20 years, so internal auditing in its current form has not proven effective in driving needed change.
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An effective internal auditing program is but one critical element in maintaining product quality and the impact can only be seen over time in a consistent and well-run program. A change in how we conduct internal auditing is needed, outsourcing for some may be the answer.
Pharma Consulting & Support
1 年Hmmh, while I agree on your analysis of the situation I do not agree on the conclusions you are drawing from it. I personally don't think that ousourcing internal auditing will be the ultimate answer here. From my perspective there is one major factor influencing the whole situation, the absence of a very strong QA department overseeing all aspects of the GMP processes and take neccessary remediation activities whenever quality considers these mandatory. However, although you will find corresponding statements almost always in companies quality manuals or else, practice very often shows that these are only words. Quality is most often not empowered enough to exercise its role to the extent needed. And, of course, in such environments internal auditing does not come up to its expectations and for sure, external, paid auditing will hardly improve on this as well. A mind change is necessary here. Look at the major big players, most if not all have a very good internal auditing system, even most of them have dedicated groups for it. This is so, because they have learnt that deficiencies in quality very quickly can put the whole organization even the whole company at risk. I guess, smaller companies still have to learn this lesson.
Program Chair-Regulatory Affairs / Medical Device Certificate Programs at UCSC Extension Silicon Valley
1 年I agree with you Mike. Nice article!
Pharmaceutical Consultant
1 年Rightly said. At least on one side expert is advisable for internal audit.
Owner, MAKJAI GROUP OF COMPANIES
1 年Interested. Kindly email the details on: [email protected]
Global GMP Consultant: Layout Designing, QMS Designing, Qualifications & Validations, Audits, Compliance Support and Trainings.
1 年Audit outsourcing is the need of time. Question is how many organizations are ready for this? Do they really understand that it is an investment for compliance? On another side there is lack of competent Auditors. The real SMEs as an auditors within and outside can together bring the necessary change.