In 2015, the US Food and Drug Administration (USFDA) issued Warning Letters to eight pharmaceutical companies for the lack of data integrity. According to the USFDA, data integrity means, “presence of accurate and reliable data in an application submitted to the FDA.”
In EU, the European Commission (EC) and the European Medicines Agency (EMA) (MHRA) provide oversight to prevent pharmaceutical data integrity issues.
The lack of pharmaceutical data integrity, if and when observed, leaves the quality, efficacy, and safety of the manufactured drug open to question. Since the data integrity issues can have a long term and negative impact on a company’s business reputation, their occurrences need to be minimized.
Few resources are available to provide guidance to a company trying to establish data governance practices and ultimately, achieve data integrity. This article discusses three steps that help companies minimize pharmaceutical data integrity issues.
1 .Preserving raw data
It is imperative that companies maintain records of the actual tests performed and also their results. For instance, in a Warning Letter issued, the FDA observed that notes regarding preparation of microbiology sample, incubation or readings and their timings were not maintained by a company.
Further, the FDA did not view favorably when the access to raw data was not limited to a responsible person or persons.
Data can be generated on paper or entered directly in a computerized system. If notes or readings are taken on paper, including scrap paper or sticky notes, those papers need to be preserved as the raw data.
2. Providing appropriate objective evidences
The entire objective evidence, such as panels of performed tests, needs to be maintained for the sake of authenticity. Pharmaceutical companies can preserve trust placed in them by maintaining proofs and verifications of various processes conducted.
In Warning Letters issued to a few pharmaceutical companies in India, the FDA noted that no objective evidence to support the claims of actual microbial testing were available. The certificate of analysis (CoA) was issued without conducting tests.
Such breaches in data integrity do not benefit a company’s business nor its reputation. It is critical that companies maintain objective evidence and detailed records regarding materials used, timing etc. to avoid any lapses in data integrity.
Find out more about how FDA Warning Letters can hinder your efforts for success in this article.
3. Developing a culture of ethics and compliance
A pharmaceutical company benefits from developing a culture of ethics and compliance among its employees. For promoting such culture, workshops or training sessions, that familiarize employees with the measures to be taken to maintain data integrity, are organized.
Also, the likelihood of implementation of these measures is higher if the measures are simple, streamlined and regularly supervised.
The companies, that have successfully exhibited good data governance, encourage their employees to report any departures or deviations from data integrity practices. When employees function without fear and are aware of their responsibility regarding data elements throughout the data lifecycle, good data governance can be easily achieved.
Establishing Data Integrity Related Regulatory Standards
Data integrity issues can be prevented by carefully understanding data integrity requirements as stated by regulatory authorities and taking appropriate measures.
At present, due to new techniques and technologies, the methods of data acquisition, storage and management are changing rapidly and simultaneously. The guidelines for maintaining data integrity are evolving too.
In many cases, hiring a consultant helps pharmaceutical companies to follow current guidelines and prevent data integrity issues. As counter intuitive as it may sound, hiring a consultant will ultimately prove to be cost-effective.
At GxP-CC, the consultants have the necessary experience to help the pharmaceutical companies achieve compliance through customized data integrity solutions and strategies.