Quality Control Professionals: Essential for Safer Drug DevelopmentJune 17, 2014
Quality control is an essential component of any successful business. Whether the product is a manufactured item or a human service, routine performance assessments help weed out malfunctions, keep production standards high, and ensure consumer satisfaction.
When it comes to developing new drugs, pharmaceutical quality control procedures are central to the successful completion of clinical trials – and to the protection of patient health. Certified professionals oversee every stage of testing, using cutting-edge analytics to determine the consistency of therapeutic results. They ensure that production practices are reliable and compliant with government regulations. If quality control managers discover an error or type of malpractice, they have the power to shut down operations until the problem has been rectified.
Take a look at 3 ways certified personnel manage the safe development of new drugs.
High Performance Liquid Chromatography (HPLC) testing is used to analyze raw materials and finished products to ensure that safety standards are being met. In the pharma quality control lab, HPLC analysts test new therapies and the ingredients used to make them – identifying, purifying, and quantifying various compounds.
The Canadian government upholds strict Good Manufacturing Practices (GMP) and requires pharma companies to perform regular tests – like HPLC – on new products. Failure to do so could result in warnings or even a plant shut-down. HPLC methods are fairly standard across the industry, so new hires are able to get started in the lab right away as valued members of the quality assurance team.
Certified validators look for consistency. They evaluate medical products based on their ability to reliably produce intended results. They ensure that new drugs and delivery systems comply with GMP and can be counted on to help patients in the ways they should – in the ways their labels promise. Validation also examines manufacturing and testing processes, bringing to light irregularities or flaws. It is an essential part of a comprehensive quality control strategy that ensures no medical product is distributed or sold without first proving its safety and efficacy.
Certified GMP auditors assess how well a company’s internal pharmaceutical quality assurance systems are working. They are experts in government regulations and can point out areas where testing or manufacturing are falling short of compliance. Auditors are hired by a company to do regular checks on its own procedures or those of its vendors. Regulators may also order audits on a particular organization, and so might its customers.
Quality Auditors examine prior assessments, create checklists, establish a Standard Operating Procedure (SOP), and recommend corrective measures. They look at and evaluate processes like HPLC testing and Validation, ensuring optimal performance and efficiency. They are the watchdogs and whistleblowers of safe drug development.
What role will you play in the safer development of health care products?