Importance of Data Integrity in cGMP: Ensuring Drug Safety and Quality : Pharmaguideline

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Importance of Data Integrity in cGMP: Ensuring Drug Safety and Quality

Data integrity violations result in various regulatory actions like warning letters and import bans.
In 2016 FDA published a guidance “Pharmaceutical Manufacturing/Quality Standards Data Integrity and Compliance with cGMP” to highlight the data integrity issues found during the FDA inspections in pharmaceutical companies. FDA emphasized data integrity and its importance to ensure the safety and quality of drugs to protect public health. Data integrity violations result in various regulatory actions like warning letters and import bans.

A report was published on drug shortage in the US in 2019 revealing that 62% of drug shortage between 2013 and 2017 was due to the production and quality issues in the products. This finding shows the importance of data integrity and quality management in pharmaceuticals.

FDA’s drug shortage report recommends developing a rating system for manufacturers to invest in quality and achieve a mature quality management system. Through this rating system the consumer can make an informed decision about the manufacturer of the medicine he buys and the quality culture will become more mature to get a competitive advantage.

Recently, FDA has issued a white paper on quality management maturity (QMM) and to get inputs from stakeholders also conducting workshops. This manufacturing facility rating will help to bring transparency in the market and force the firms to implement data integrity and quality management effectively.

Process analytical technology played an important role in creating a quality ecosystem in pharmaceutical manufacturing. Advanced technology and the introduction of computerized systems in pharmaceuticals improved process understanding, reduced cycle time, enhanced process efficiency, and reduced cost with improvement in product quality. The integration of new technologies in pharmaceuticals provides real-time control and drives the sector toward digitalization.

Compliance and validation of the processes may increase the workload and documentation burden but it helps to improve the quality system in the firm and develop a powerful quality management system. FDA is actively supporting the firms to improve quality and also aims to streamline the manufacturing process with its efforts.

In highly regulated industries data integrity maturity programs plays an important role in practicing good data collection and integrity. This type of program ensures high-quality standards, reduces cost, improves efficiency, and helps the assurance of data integrity.

Continuous improvements and the industry shift towards modular manufacturing highlight the requirements for real-time feedback. To get actionable insights real-time data and an effective data process ecosystem is required.

To meet the regulatory requirements a robust quality management system and assurance of data integrity are essentially required. It will improve the product quality and build customer trust in the manufacturing firm.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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