Data integrity/management violations or accommodating flawed regulatory requirements for compliance?

It has almost become fashionable to talk out loud about data mismanagement and integrity issues in the pharmaceutical industry highlighting lack of trust in the industry’s competency and honesty by the regulators and associates, which is really unfortunate. Please, do not be this distrustful! Many times many influential people in regulatory agencies come from the industry and vice versa. People cannot be dishonest only on one side. I doubt that the pharmaceutical industry has a higher ratio of bad behavior to good behavior when compared to any other industry – perhaps less.

In my opinion and experience, people in the pharmaceutical industry are doing their best to accommodate flawed (non-scientific and illogical) regulatory requirements. It is the regulatory authorities which have to correct their assessment methods and approaches including inspections.

For example, considering the case of generic product assessments, both in vivo (bioequivalence) and in vitro drug release/dissolution, are based on scientifically invalid methods and/or testers which cannot provide accurate and reproducible results as well as quality products. This would simply be impossible. To bring the data/results within acceptable range to meet compliance requirements, not the quality which is undefined as of yet by the authorities, the industry has to “play” with numbers and techniques such as repeats and discarding test results. This appears “data fudging” (or “dishonesty”), most often to those who have limited expertise and experience working in the laboratory environments. Please avoid such blames under the practices of computer software validation, data integrity, data security, missing data trails, etc. These are neither helping nor addressing the underlying issues.

The only possible solution to address this lack of trust situation is that the regulatory authorities, including pharmacopeias, have to clearly define quality of the products with an objective measurable parameter. Let the industry meet these standards using scientifically valid and qualified methods not working with the flawed science imposed by the authorities.

The following are some relevant links provide further details in this regards:

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