Validation Times articles from April 2003

Validation Times archives from April 2003

FDA says PAT will not be mandatory; industry wants assurances on sharing information, flexibility. (Process analytical technology).
April 1, 2003... FDA has no intention of making process analytical technology (PAT) mandatory, but industry executives are concerned how to implement it. Center for Drugs Director Janet Woodcock, M.D., during questioning at a joint FDA-Product Quality...

FDA admits not comparing drug GMPs in drafting supplement rules; some standards stiffer than for OTC drugs. (Supplements).
April 1, 2003... FDA officials have acknowledged that some of the proposed GMP requirements for dietary supplements are stiffer than what FDA requires of OTC drug companies, but the agency admitted it did not do a side-by-side comparison with 21 CFR Part 211...

PQRI work group sees need to define risk product-by-product; development report concept lauded. (Risk management).
April 1, 2003... FDA says it wants GMPs to be risk-based, but when it came to defining risk, a joint FDA-industry work group meeting in Washington April 22-24 could not come to a consensus on what it was, except that risk should be product-based and there was...

An academic perspective on assessing risk.
April 1, 2003... Gregg Claycamp, Ph.D., a former professor at the University of Pittsburgh, and now a senior advisor on risk assessment at FDA, provided conference attendees a range of methods by which risk may be assessed. Put simply, risk arises when...

N.J. District chief urges drug firms to devise 'risk matrix,' 'critical control points' to prevent flaws. (Risk management).
April 1, 2003... ATHENS, GA -- Pharmaceutical companies should consider devising a "risk matrix" on where potential flaws can occur in their production processes, perhaps employ the "critical control points" method in food processing and handling, because FDA...

Inadequate QA staffing, training blamed for GMP failures and FDA compliance actions. (Quality systems).
April 1, 2003... ATHENS, GA -- Could inadequate staffing and poor training be the Achille's heal of pharmaceutical QA? A former FDA compliance officer and ex-Warner Lambert QA executive thinks so. Addressing the University of Georgia College of...

OOS validation least of problems at Alkermes when agency finds problem with vial rejection on filling line. (Human drugs).
April 1, 2003... Cincinnati District investigators Kathleen Culver and Mark Parmon issued two verbal observations to management at Alkermes Controlled Therapeutics II concerning validation of out-of-specification (OOS) input data and a failure to conduct...

Exec questions FDAer's use of guidance docs during audit. (Human drugs).
April 1, 2003... Best Formulation, did not take a July-August 2002 inspection of its drug manufacturing facility lying down, disputing observations of unvalidated control and cleaning procedures on the grounds that guidance documents were being cited as...

Equipment calibration, Part 11 nets Quintiles 483 following two easy audits. (Human drugs).
April 1, 2003... Quintiles' luck ran out on a third inspection in 2002 at its Kansas City plant, thus netting the firm a three-item 483 after receiving verbal warnings during two inspections in 2000. The plant conducts contract blending work for major drug...

Responsibility for validation, distributor status nets TRF a warning letter. (Medical devices).
April 1, 2003... Confusion about distributor status and validation responsibilities coupled with a voluntary recall of over 200 dura mater allografts were likely motivators for Transplantation Research Foundation (TRF) to revise its processing agreement with...

Concept unclear on cleaning validation, FDA states. (Human Drugs).
April 1, 2003... FDA hit Chicago, IL-based Concept Laboratories, with failing to validate equipment cleaning and sanitizing procedures, and that procedures did not specify the type of germicidal detergent to be used on equipment in a Feb. 26 warning letter. ...

Crown Labs caught in web of inadequacies. (Human drugs).
April 1, 2003... A Feb. 28 warning letter stated Crown Laboratories, had no cleaning validation for its drug products or equipment. The agency further hit the Johnson City, TN-based firm with a laundry list of deficiencies including: inadequate sampling and...

Shampoo maker needs to validate manufacturing procedures. (Human drugs).
April 1, 2003... A March 3 warning letter hit Pride and Power, Inc., with failure to establish and validate written manufacturing procedures for its Don't-B-Bald Hair and Scalp Treatment Medicated, Don't-B-Bald Scalp Stimulate, and BBD 1854 Dandruff Shampoo....

German device maker gets drilled on Part 11, 510(k) deficiencies. (Medical Devices).
April 1, 2003... Center for Device's Office of Compliance hit the German manufacturer of cranial drills, burrs and trephines Georg Leibinger for using software that was not validated to maintain quality system records, such as device history and change control...

Calibration, labeling woes beleaguer Dennis Welding. (Oxygen).
April 1, 2003... Dennis Welding Supply failed to maintain complete records of the periodic calibration of its oxygen analyzer, and failed to follow its own labeling procedures, a Feb. 28 warning letter stated. The agency added that the Montgomery, AL-based...