1. In your opinion, what is the key to conducting a successful GMP/GDP audit?
It’s hard to name the only factor that defines a successful audit. In reality, it’s a combination of several elements, and any one of them might have the key role in a given situation.
The audit process can be divided into four stages: preparation for the audit, analysis of the audited object, reporting and elimination of existing flaws.
Each of the stages has its features which determine what deserves more attention in order to get the maximum efficiency from the auditor’s work.
During preparation, it’s essential to consider the company’s historical experience and to detect the crucial processes that will take the majority of the auditor’s time. The standards which constitute the grounds for an audit are an essential part of the auditor’s job.
When on-site, the audit team has to be sure of what is supposed to be seen and when. At the same time, the auditor has to be flexible enough to build up the interview strategy and to make a proper interpretation of observations. Along those lines, the inability to build up efficient communication during an audit stultifies all the preparatory efforts and can influence future cooperation negatively as well.
2. What are the 3 most important points on the checklist for GMP/GDP compliance?
Usually, I don’t use a checklist for reporting. I consider making a well-thought-out report structure beforehand to be more important: required chapters, the depth of information detailing in the report, available appendixes to the report.
As a rule, there is a corporate standard or template in a company that has to be used during the reporting. And in actual fact, the standard determines the auditor’s job on-site: in some cases, a detailed report is needed, while in others, the auditor describes only the circumstances that initiate the inconsistency. The auditor’s task is to analyze in advance the report structure and define his job on-site in such a way that enables him to describe afterwards in written form all the observations according to the template information requirements.
Moreover, I'd like to pay attention to formulating the remarks in the report. It is necessary to evaluate a remark’s wording in relation to the requirements which make up the audit criteria. Sometimes you can come across remarks which reflect the auditor’s vision of the ideal process, but not remarks that consider which requirement has been violated and exactly how. That is why a link to the standard, including the exact chapter which has been violated, is of such importance. This approach helps both the auditor and the audited party, allowing them to properly understand the reason behind the problem and to propose the means required for improvement.
3. What are the most common mistakes in preparing/conducting an audit?
I think it’s correct to say that mistakes have a greater impact on the consequences. Considering this, a big fault during the preparation phase would be the insufficient analysis of available data regarding cooperation experience with the audited company (taking into account formerly discovered inconsistencies, violations of contracts or, on the other hand, any positive experiences) because this allows for the proper distribution of the resources during the audit.
As for mistakes made while the audit is being conducted, I’d point out communication problems, namely inefficiency of communication: inability to listen, lack of respect, misunderstanding of cultural peculiarities, etc.
4. How do you evaluate the readiness of the companies on the Russian market for GMP/GDP compliance?
I do not have such wide statistics, and more than that, “the readiness of the companies” is something like the “average mean”. There are so many companies and they differ greatly. We also have both international companies and Russian ones, including companies established during the time of the USSR. And I’m not saying that one is better than another, I want just to point out the diversity of the companies working on the Russian market. There are both advanced and outdated companies.
Along with that, I would like to put an accent on several important aspects. First of all, do not forget that GMP standards or rules harmonized to European standards, became obligatory just a few years ago. GDP standards have existed until now only as an experiment. Because of that, the real working experience in these terms is not so deep.
The situation, in my opinion, becomes complicated because a “quality culture” or “quality philosophy” is not formulated yet in our country. This is the topic of a separate discussion, but the main idea is stated in the efficient management basics formulated so well by Deming in his 14 principles of quality management. They are designed to fight against “lethal diseases”, such as: absence of constancy of the purpose, domination of numerical goals in the corporate management, lack of quality leadership from the top management and others.
These are the basics really, but without them, the proper practices cannot fully function, because this is not just a set of standards, but first of all a philosophy which has been forming itself in the minds of experts and in the engineering community for quite a long time now. The establishment of this philosophy is running in parallel with the development of civil society. As soon as people become more open-minded and more responsible, they develop trust in each other, and at the same time become more receptive to the idea of a quality philosophy and to proper practices. The quality philosophy does not exist where people are not responsible for themselves or are afraid of being fired for their mistakes.
Probably some people do not agree with my evaluation, but everything I’ve said reflects my personal point of view.