Microbial data collection environmental monitoring is a growing challenge for the pharmaceutical industry in an increasingly digitized industry. Manufacturers must be able to guarantee their blend of automated and operational processes are under statistical control while ensuring their data is secure and accurate. With the improvements made to other areas of production, there is a growing need for modern solutions to environmental monitoring and microbial data collection in critical areas.
A Changing Pharmaceutical Industry
The adoption of computers and automation in modern industries has dramatically increased the amount of data to be managed.
Over time, pharmaceutical manufacturers have changed their processes to separate operators from products. Today, several already use robotic filling lines, further blurring the line between digital systems and operations. Information technology is a growing need as more companies adopt these solutions to manage so-called “big data”. Environmental monitoring (EM) procedures could eventually be completely integrated into digital systems, preventing deviations and errors. For example, microbial data collection might be managed exclusively through digital means. The significant volume of data generated from EM should be managed in compliance with good manufacturing practice (GMP) guidelines to ensure reliability and integrity.
This paper also discusses:
- Statistical Control and Your Process
- ALCOA
- FDA Inspections for Data Integrity
- Microbial Monitoring
- Sampling Devices and Industry 4.0
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