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The Importance Of GMP Certification In Drug Development

Production and sale of therapeutic drugs requires tight control over the manufacturing, processing, and labeling of these products to ensure the safety of the end user. In the United States, regulations for maintaining the quality of medications such as these are under the jurisdiction of the Food and Drug Administration (FDA). They are referred to as Good Manufacturing Practice (GMP) or Current Good Manufacturing Practice (CGMP) regulations. GMP regulations mandate that manufacturers demonstrate the safety, purity, and efficacy of drug products during clinical testing and after drug approval. These regulations include having suitable quality management systems in place, ensuring the integrity of materials used, establishing appropriate operational processes, and using compliant laboratory facilities to support product characterization and testing. These are considered minimum requirements but are broad reaching, spanning from the proper maintenance and calibration of equipment to the acceptable performance of an analytical test for measuring drug purity. Ultimately, the GMP regulations are designed to monitor the full manufacturing process, maintain quality drug products, and protect consumers.

One way that the FDA ensures consistent quality is with the GMP certification. This certification is given when manufacturers and/or testing facilities demonstrate that they comply with proper regulatory and operational standards to ensure the FDA GMP requirements are met. GMP practices include establishing strong quality management systems, robust operating procedures, identification of deviations in product or service quality, and the maintenance of compliant testing facilities. To obtain this certification, companies must undergo extensive evaluations or audits to establish that standard operating procedures (SOPs), facilities, quality systems, and operational staff meet or exceed requirements. After the FDA auditor issues the GMP certification, the company must undergo repeated inspections and demonstrate continued compliance to maintain the certification. GMP certification is credible proof that a facility provides the highest quality support for pharmaceutical partners in the drug manufacturing and testing process. This is as important at the early stages of drug development support as it is at the later stages of production for marketed drug products. 

In July of this year, BioAgilytix proudly announced that our Hamburg, Germany facility received GMP certification. This expands our GMP service offerings by adding to our GMP site in Durham, North Carolina, which has been certified since 2010. With GMP certified laboratory locations now available in both the US and the EU, BioAgilytix is well positioned to partner with clients around the globe to offer a full suite of bioanalytical lifecycle services in support of the release, production, and manufacturing of therapeutic drugs. Our GMP certifications guarantee that by partnering with BioAgilytix, you gain a teammate who holds themselves to the highest standards, maintaining the quality and dependability of our bioanalytical program to support your GMP assay needs. 


  1. https://jamanetwork.com/journals/jama/article-abstract/2762311 
  2. https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
  3. https://cdn.who.int/media/docs/default-source/biologicals/gmp/gmp-workshop-seoul-sep2018-report-ver-web-1.pdf?sfvrsn=b9093894_2&download=true
  4. https://www.who.int/activities/standardizing-biotherapeutic-products

Partner With BioAgilytix
BioAgilytix provides biomarker, immunogenicity, cell-based assay, and other laboratory services for pharma and biotech companies around the world. We are a leader in immunogenicity testing, an important step in drug development, evaluating anti-drug antibodies prior to treatment, and analyzing drug efficacy in a patient over time. Contact BioAgilytix today with any questions or requests.

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