Quality Standards for Pharma

 

Tue, 07/28/2015 - 2:30pm Lindsay Hock, Editor Image: Charles River Laboratories When you go to your local Walmart, CVS or Wallgreens to pick up cold medicine (or any other health product), do you ever think of the quality of the product? More than likely you grab the product off the shelf and hurry home to remedy your illness or whatever health ailment you might face. Little do we think of the testing behind the medications prescribed to us that improve the quality of our lives. Yet, stringent testing is needed for any pharmaceutical or health care product to hit the shelves of your local convenience store. Why is quality control testing so important for pharmaceutical and health care applications? The short answer: Any product of inferior quality can have negative outcomes for patients. For this reason, quality control testing is one critical safeguard used to prevent products that don’t meet exacting specifications from reaching patients, protecting public health. “Additionally, manufacturers use the feedback gained from quality control testing results to continuously improve manufacturing process in an effort to reduce errors and deliver quality products more efficiently,” says Carl Craig, PhD,  Corporate VP, Charles River Laboratories. Quality control for pharmaceuticals For the quality control testing of pharmaceutical and health care products, The United States Phamocopeial Convention (USP) establishes, through the use of expert committees, uniform quality standards that are enforced by the U.S. Food and Drug Administration (FDA). These standards are similar to those of the Japanese Pharmacopeia and the European Pharmacopeia. The quality standards are documented as Compendial Tests, and every pharmaceutical product is subjected to the appropriate Compendial Test as a way to demonstrate product quality, efficacy, potency and so forth. By its nature, the regulated pharmaceutical products market is conservative and slow to adopt change in quality control testing. “After all, if the regulatory bodies, such as the USP and FDA, have determined existing quality tests are working to protect public health, any change could potentially have a negative impact on the public,” says Craig.   However, rapid testing is now at a place where it can meet the same quality specifications of traditional testing methods, only faster. “In many cases, rapid tests deliver results hours and even days before traditional methods,” says Craig. “This has obvious economic benefits for business; it expedites product release.” Rapid tests also allow for products to be reliably tested and released based on the quality control data, whereas with traditional methods the products may be released and used “at risk”, only to receive the quality testing results after the product’s release and use. “With that said, the industry has struggled to validate these rapid test methods,” says Craig. This is mainly due to this industry’s reluctance to change traditional quality control procedures that have protected human and public health for decades. And since rapid methods are considered “alternative methods” by regulators, and must be independently validated according to specific guidance outlined in the respective pharmacopoeias, manufacturers of rapid methods must appeal to regulators for approval. This slows the adoption of these methods, and ultimately the time pharmaceutical and health care manufacturers can get products to market. The endotoxin way Endotoxin testing is a rapid quality control test method that takes hours versus days to reach results. And, according to Craig, endotoxin testing has clearly demonstrated improvements over the previous “compendial rabbit pyrogen method of quality control.” Technology based on limulus amebocyte lysate (LAL)—a key ingredient in horseshoe crab blood that reacts in the presence of gram-negative bacteria—has progressed to the point where rapid cartridge-based systems now enable companies to rapidly measure endotoxins. The technology works like this: Precise amounts of LAL reagent, chromagenic substrate and control endotoxin are pre-loaded onto a four-channel cartridge, at which point the cartridge is placed in a handheld reader that serves as an incubator (that heats the cartridge to 37 C), a pumping system (that mixes the sample with each of the reagents applied to the cartridge) and spectrophotometer. The LAL method provides results in about 15 min. The most recent advances in LAL technology include a multi-cartridge system and a fully automated, robotic system suitable for high-volume water testing. “Since the advent of mandatory endotoxin testing for drugs, biologics and medical devices in the early 1980s, there hasn’t been a single incident of a product recall due to endotoxin contamination from a failure of an endotoxin assay that has been properly performed,” says Craig. And, with the advent and FDA approval of Charles Rivers Laboratories’ Endosafe-PTS method of rapid endotoxin testing in 2006, the company has seen a successful decrease—days to minutes—in test time that demonstrates successful adoption of simpler, less-invasive, more reliable rapid methods that don’t compromise public health. “We hope the successful adoption of rapid endotoxin testing can be a blueprint for adoption of other rapid methods in the future,” says Craig. The future of quality control testing What does the future hold for pharmaceutical and health care product quality control testing? Technological improvements combined with cost improvements will be at the forefront of future methods and technologies. “Technological improvements, alongside the significant and often unnecessary cost of having products sit and wait for testing to be completed before the product is release or moved to the next step, has strengthened the case for quality control testing that’s simpler, faster and more automated,” says Craig. There’s also a movement within the pharmaceutical industry to bring quality decisions closer to the manufacturing floor. With this trend, there’s an opportunity to develop easy-to-use and rapid quality control methods that can be decentralized from the quality lab and used by technicians in manufacturing without compromising testing quality or public health. “This allows for more timely and accurate decision to be made regarding the release of regulated products,” says Craig. source : www.rdmag.com