Third Party Testing
Who is a Third Party?
An independent organization that is not involved in the design and implementation of the product being tested and is not intended as a user of the product.
What is Third Party Testing?
Independent Third-party testing and certification is a quality control process where an independent organization reviews and tests a product to see if it meets specific scientific quality standards. The testing is usually focused on the manufacturing phase of goods regarding quality sourced ingredients, strength and how well the finished product formulation performs under certain conditions.
What is CGMP?
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMP provides systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This ensures that drug products meet their quality standards.
The CGMP requirements were established to be flexible to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up to date to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.
It is important to note that CGMP regulations for drugs contain the minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.
For more information, read our blog article about The Difference between Natural and Pharmaceutical Drugs
Free Recycling Program
Pure Encapsulations and its affiliated brands have partnered with TerraCycle to develop a free recycling program for their hard to recycle nutritional supplement packaging. Now you can recycle: Pure Encapsulations, Douglas Labs, Genestra, Klean Athlete, Pharmax, UNDA and Wobenzym brand packaging.