Cleaning Validation Risks: Front-Line Strategies for an Effective and Compliant Program

Venue: Virtual

Location: Virtual, United States

Event Date/Time: May 27, 2009
Report as Spam


The FDA is cracking down hard on drug and device manufacturers for violating their cleaning validation processes and protocols.

For example, in a recent warning letter, one company received five paragraphs of cleaning validation violations — from failure to have cleaning validation studies to a lack of documentation describing the preparation of the cleaning/sanitizing agent.

But you don’t have to fear Form 483s, warning letters, lawsuits, recalls or bad publicity — if you have front-line strategies in place for implementing an effective and compliant cleaning validation program.

Maintaining or cleaning equipment at appropriate intervals or lack of indication of final rinse verification may seem like small issues on the surface but can easily lead to serious cleaning validation violations. Do you know the best strategies you can implement to avoid these — and other — disasters through every step of the process? For example, are you aware:

* Equipment must be located and configured to allow for proper cleaning and all cleaning procedures must be documented and logged?
* Every contact point during every step along the processing path creates a contamination risk and must be dealt with?
* Cross contamination can occur if more than one product, or its components, are in the same space or come in contact with the same equipment or utensil?
* The chemicals and solvents used to clean equipment are crucial — the wrong one can fail to accomplish the cleaning task or could leave a residue?
* Equipment that is porous, such as filters, can break down over time or can be damaged by solvents and create adulterating substances?
Equipment and utensils that have not been validated for cleanliness can cause thousands of drug doses or devices to be adulterated — a further GMP violation. Plus, contaminated products that make it to market can cause patient injury resulting in recalls, bad publicity, fines and lawsuits.