FDA Emphasizes Importance of Regular Water Sampling in Pharmaceutical Plants

Strategic Insights -

Pharmaceutical companies must take regular water sampling and validation of water systems seriously, as emphasized by FDA experts at the 1998 West Coast Chapter meeting of the Parenteral Drug Association (PDA). This emphasis comes as part of a broader effort to standardize and clarify regulations surrounding water control, both for air and water, in pharmaceutical manufacturing facilities.

Key Takeaways:

  • Regular water sampling is essential in all water sources, including taps, to ensure consistency in pharmaceutical manufacturing.
  • The FDA is developing a guidance document to clarify regulations on water sampling and validation, which is expected to be released soon.
  • The guidance document will cover both air and water systems and will be coordinated with the FDA's Office of Regulatory Affairs.
  • All water sources should be sampled on a regular basis, with the goal of replicating other aspects of Standard Operating Procedures (SOPs).
  • Only in a few cases, such as taps not used in production, can a tap be excluded from sampling, and even then, only with common sense.
  • Continuous loop systems with regular flushing procedures may allow for reduced sampling, but only if adequate data justify it.
  • Chiron has experienced inconsistencies in the interpretation of water-related procedures, highlighting a problem faced by some companies.
  • Environmental monitoring, including air quality and clean room issues, will be checked at every audit.
  • Common problems include the performance of smoke studies, clean room issues, and neglecting to test for airborne particulates.

Statistics:

  • The FDA is developing a guidance document to clarify regulations on water sampling and validation (expected release date not specified).
  • Regular water sampling is essential in all water sources, including taps.
  • Only a few cases can exclude a tap from sampling, such as taps not used in production.
  • Continuous loop systems with regular flushing procedures may allow for reduced sampling if adequate data justify it.

Sources:

  • FDA's Center for Biologics presentation at the 1998 West Coast Chapter meeting of the Parenteral Drug Association (PDA)
  • Philip Lindeman, a compliance officer in FDA's San Francisco District Office
  • Dr. Rebecca Devine, PhD., associate director for policy at the Center for Biologics
  • Frank Matarrese, associate director of compliance at Chiron