FDA releases new draft guidance on cGMP Drug Manufacturing

As on 3 Feb 2015, it has been reported (find FDA’s report here) that fifteen companies from the Indian subcontinent have received warning letters from the US Food and Drug Administration (FDA) for their problematic data integrity practices. The health authority has also issued import alerts to some of them restricting their products enter into the US.  In addition, some of the manufacturers from the subcontinent were reprimanded by the European Medicines Agency (EMA) and the World Health Organization (WHO) for not adhering to the data integrity regulations. In China, similar instances have been found where manufacturers tried to alter the raw data file names for which they have been banned on cGMP concerns.

Addressing the critical issue of data manipulation and other data integrity concerns while documenting current Good Manufacturing Practices (cGMP) records, the US FDA on last Thursday (4 Apr 2016) has released a draft guidance to ensure the data being submitted is consistent and accurate.

What is Data Integrity?

In simple terms, Data Integrity refers to maintaining the complete, consistent and accurate data which should be attributable, legible, original, and truthful.

New Guidance

The 13-page new guidance includes 18 questions that answer what is Data Integrity and provides well-defined terms on how the data being entered should be relevant to cGMP records. It also includes:

  • recommendations on when workflows on computer system need to be validated
  • how should electronic master production and control records (MPCR) be monitored
  • user authorization inputs

While submitting the data to the FDA, the electronic data generation should fulfill cGMP requirements i.e. it should tag/include relevant Meta-data to enable reviewers to understand the contextual information easily. In addition, the guidance states that the exclusion of any information from the release criteria decision-making process needs a valid documented justification.

If companies still using paper-based records, the FDA confirms the process of record retention and record review will not differ.

Maintaining data is such a painful task for companies especially when it has to be compiled for showcasing current good manufacturing practices. The remedy is to be proactive by conducting quality compliance drives and be vigilant on data management practices. It is recommended to consult an end-to-end Regulatory Services partner who can cater GMP support services including audits and inspections (internal and external) preparing quality manuals, and standard operation procedures.


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