What does CV stand for?

Concept Laboratories failed to have cleaning validation studies for products manufactured with equipment used to produce not only drug products, but also "household cleaning agents and other industrial products.

Krakow, Poland, CDER A preapproval inspection of Pliva Pharmaceutical's Krakow drug manufacturing facility yielded one "significant GMP deficiency related to incomplete cleaning validation studies for all multi-use equipment used in the manufacture of Ondansetron HC1 Tablets," the EIR noted.

Establishing Scientifically Justified Acceptance Criteria for Cleaning Validation of Finished Drug Products.

Industriale Chimica, Sacronno, Italy, CDER Industriale Chimica, Sacronno, Italy, received a two-item 483 due to incomplete cleaning validation in the production of active pharmaceutical ingredients (APIs).

Dear Reader, A pharmaceutical industry consultant, who conducts GMP audits and evaluations of chemistry, manufacturing and controls (CMC), said last month that many of the 483s and warning letters she reviews cite insufficient or lack of cleaning validation as significant problems.

ReadyToProcess technologies allow considerable advantages over conventional methods used in bioprocessing, including: higher project throughput and shorter time to market due to the elimination of cleaning and cleaning validation steps, elimination of cross contamination problems and reduce training and certification of employees due to the convenience of a ready to use format.

The good news is that by being cognizant of areas outside his or her traditional zone of awareness, the pharmaceutical project manager responsible for cleaning validation can develop a program with a positive impact that reaches beyond compliance with GMPs.

The firm responded during the inspection that it was unsure when cleaning validation would be completed.