Validation plans touted for water, but SOPs needed.(water quality standards for pharmaceutical industry)

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Validation Times , 12/01/1999 1 9

Validation plans touted for water, but SOPs needed.(water quality standards for pharmaceutical industry)(Brief Article) Dechnik, Peter *~|~*

COPYRIGHT 1999 Washington Information Source

PHILADELPHIA -- Validation master plans can help pharmaceutical firms deal with water and other utilities problems, and not just to meet FDA or USP requirements, firms were advised here Dec. 7. There is still no sign of FDA's draft guidance on water, which is being overseen by the Center for Biologics (See Guidance Tracker, page 18).
However, at ISPE's winter conference here, manufacturers learned that not only FDA, but non-U.S. regulators, are becoming concerned about water quality.
"FDA sees water as a raw material like sucrose, lactose or any other ingredient in your drug," said Rosty Slabicky, manager of systems validation at Boehringer Ingelheim, Danbury, CT. "The FDA inspector will ask the source of your water. How do you know it's drinking water? Does it comply with established standards?"
Because FDA looks at water primarily from a microbial aspect, Slabicky advised QA personnel to "take a few courses in microbiology. You will have fewer headaches later."
He noted that if USP standards do not apply to a firm's situation, then the firm must create its own standards, as explained in the USP introduction. "FDA will check your water according to your documented standards," Slabicky explained. "If you have knowledgeable people making knowledgeable decisions, the worst the FDA will say is that you made a mistake."
SOPs needed
Validation of the water system must show that SOPs are valid and that the system can consistently produce water meeting the desired specifications. The system must also be able to handle seasonal variations in feed water.
"You should have at least a draft SOP in place before you validate," Slabicky said. "You can't rely on a shelf full of validation texts." He also stressed that validation is distinct from commissioning, saying: "You don't want validation people out in the field inspecting the welds on water pipes."
The water sampling SOP is critical and should include training of the sampling personnel. He decried companies that believe "if the sample is wrong, fire the sampler." He said: "Suppose the sampler must stand on a rickety seven-foot ladder to obtain a sample from a water pipe and you didn't know he's afraid of heights."
Patricia Stewart-Flaherty, validation manager at Bayer, Clayton, NC, emphasized that a validation master plan for an overseas facility may need to comply with not only FDA standards, but also with those of the U.K.'s Medicines Control Agency or other European Union (EU) auditors.
She advised that a master plan be created for a facility that is about halfway through the design stage. "I've often sat down with regulators to review our master plan and identified potential problems," Stewart-Flaherty said.
The master plan should identify the persons responsible, not the entire facility. "Be sure to include the names of individuals to satisfy CFR 211.25 personnel qualifications," she said.
Stewart-Flaherty recommended that the master plan include floor plans of the facility, equipment location, flow diagrams and product flow. "Use plenty of color. Remember, you may need to make a presentation to a regulator."
She said that a master plan for a new facility or system could be created in two or three months, but that prior preparation was essential. "If you begin two or three years ahead of time, you can do a better job of blocking out the time for everyone," the executive added. "You can expect production people to say they're too busy to spare enough time."
The presentations on water are $20 plus retrieval, Doc. 110119R.

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