As a partner entirely committed to upholding scientific excellence in every stage of the bioanalytical lifecycle, from discovery through manufacturing, we help ensure the quality and safety of the processes behind your manufactured biologic breakthroughs.
As defined by The International Society for Pharmaceutical Engineering (ISPE), “A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.”
Good Manufacturing Practice (GMP) standards and guidelines have evolved over time, but their central purpose remains to ensure the purity, quality and safety of manufactured products. Enforced by the FDA, the World Health Organization (WHO) promotes the most widely leveraged version of GMP regulations.
GMP laboratories are laboratories that follow and systematically document adherence to Good Manufacturing Practice regulations, recognizing the importance of putting quality first and upholding production excellence at every step of the pharmaceutical manufacturing process.
GMP regulations are inclusive of every aspect of manufacturing, spanning materials, facilities, equipment, production, packaging, training, and standard operating procedures (SOPs). The principles promoted are clear: cleanliness, control, accuracy, quality, and safety.
The enforcement of Good Manufacturing Practice (GMP) is an integral step in the approval process for biologics, which can consist of inspections, samples, and track record. As a laboratory facility with a strong track record of GMP adherence, BioAgilytix ensures that GMP compliance will not stand in the way of your drug approval.
Both Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations are vitally related to laboratory testing. However, the two categories of regulation have notable differences, beginning with their end goal. GMPs focus on data integrity, maintaining and demonstrating adherence to specific manufacturing criteria that ensure quality and safety of the end product.
As a GMP and GLP laboratory, BioAgilytix focuses centrally on assuring the consistency, quality and safety of all manufactured biologic products by adhering to Good Manufacturing Practice procedures and regulations.
At BioAgilytix, our GMP-compliant bioanalytical lifecycle services support the release, production and manufacturing of biologics, biosimilars, and biobetters—including the optimization of assays to promote process improvement and measurement.
Our commitment to Good Manufacturing Practices adherence is far more significant than regulatory compliance alone. Good Manufacturing Practices are central to our commitment to our customers and their customers, as well as our promise to uphold quality and dependability in every service we perform.
Our unwavering focus on quality control is far more expansive than GMP regulations. In fact, our commitment to continual quality improvement is brought to fruition by our highly capable Quality Assurance Department, which adheres to rigorous requirements, including GMP, GLP and GCP regulations.
Let us help you bring clarity to the complexities of biologics with full GMP compliance.
Afshin Safavi, Ph.D., Founder & CSO of BioAgilytix, shares his expert perspectives with Bioanalysis Zone.
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