Pharmaceutical quality control testing to meet safety and quality requirements
Independent quality control testing of pharmaceutical products is an essential activity that helps to ensure their safety and efficacy. In this brief article, we’ll discuss the application of quality control (QC) testing to pharmaceutical products and the specific types of QC testing and evaluation required under various applicable standards.
What are pharmaceutical products?
Pharmaceutical products are typically drugs and other chemical preparations used to diagnose, cure, treat, or prevent disease, and play an essential role in the identification and treatment of both human and animal illnesses. In modern medicine, pharmaceutical products serve many different purposes, such as the control of infection or relief of pain, to facilitate or impede contraception or to provide nutritional benefits. To ease their administration, pharmaceutical products come in multiple forms, including tablets, capsules, soft gels, liquid suspensions and injectables.
Why is quality control important?
Because of their critical role in the treatment of disease and the maintenance of good health, quality control is one of the most important functions in pharmaceutical production. For pharmaceutical manufacturers, rigorous quality control is required at all stages of product development and manufacture, from the sourcing of raw materials through to the release of finished products. Effective quality control procedures help to ensure the quality and consistent of pharmaceutical products from supplier to supplier and even from batch to batch.
What is the function of third-party quality control testing?
Most national and international buyers require testing and verification of sample products to verify the effectiveness of a manufacturer’s quality control process to assure the safety and efficacy of pharmaceutical products. Typically, this testing is conducted by an independent third-party testing organisation with extensive experience in pharmaceutical quality control testing. Quality control testing can be conducted on raw materials as well as finished pharmaceutical products.
What is the basis for how quality control testing is conducted?
Pharmaceutical QC testing of products is commonly based on international and/or national standards such as U.S. Pharmacopeia (USP), the European Pharmacopeia (EP), the British Pharmacopeia (BP), the International Pharmacopeia (IP) and others. While there are variations in the specific requirements of each of these standards, all are consistent with industry-accepted good manufacturing practice (GMP) principles.
What types of tests are performed during quality control testing?
The type of quality control tests that are performed may differ depending on the type of pharmaceutical product, the source of raw materials, the production process and other factors. However, quality control testing parameters typically include physico-chemical analysis, identification and assay of active pharmaceutical ingredient(s) (API), impurities and related substance testing, microbiological evaluation and stability studies.
Why should we consider TÜV SÜD for quality control testing of pharmaceutical products?
TÜV SÜD’s Chemical Centre in Singapore has been accredited to the requirements of ISO 17025 by the Singapore Laboratory Accreditation Scheme (SAC-SINGLAS), and is listed as World Health Organization’s (WHO) Prequalified Quality Control Laboratories. Our state-of-the-art testing facilities feature the most advanced pharmaceutical testing and analytical equipment available. These qualifications, combined with more than 30 years of experience in testing and product certification services, mean that our quality control testing reports and certificates are widely accepted around the world.