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.
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.
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.
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.
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.
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