cGMP Manufacturing

In the United States, the Current Good Manufacturing Practice (cGMP) is the Food and Drug Administration (FDA) 's formal regulations on the design, monitoring, control and maintenance of manufacturing processes and facilities. Pharmaceutical and biotechnology companies comply with cGMPs to ensure that their products meet specific requirements, including characteristics, strength, quality and purity. Compliance is regulated by the FDA. There are many federal regulations related to cGMP, failure to comply with them will lead to criminal penalties.

Code of Federal Regulations (CFR)

The Code of Federal Regulations (CFR) is the compilation of general and permanent regulations from the federal government. The CFR contains the full and official text of regulations enforced by federal agencies. The FDA's section of the CFR, in title 21, explains the federal food, drug, and cosmetic act and related regulations, including the public health services act. Pharmaceutical or drug quality regulations also appear in several sections of title 21.

The cGMP Manufacturing Service

Creative Biolabs has experienced and well-trained production personnel, lab equipment are validated and inspected periodically to strictly comply with cGMP. Daily environmental monitoring ensures compliance with appropriate room classification and demonstrates microbiological and particle control in the production area. In addition, quality control personnel review processes, procedures, and batch records regularly.

The products for antibody characterization at Creative Biolabs not only involve the commercial aspects of therapeutic antibody pharmacokinetics but also relate to quality assurance in basic research. The following provides detailed technical resources for antibody characterization.

  • We offer the independent GMP suite dedicated to microbial, insect and mammalian platforms.
  • Our specialization in plasmid DNA production and purity.
  • Advanced packaging/filling equipment.
  • We bring in effective process validation.
  • It has been rigorously tested by cell lines.
  • All the upstream and downstream processes use a single system.

The requirements of CGMP are flexible so that each manufacturer can decide how to use scientific and reasonable design, processing methods and testing procedures to best implement the necessary controls independently. The flexibility of these regulations allows companies to use modern technology and innovative methods to achieve higher quality production through continuous improvement. Therefore, the "C" in CGMP stands for "current" and requires the company to use the up-to-date technologies and systems to comply with regulations. If you’d like to know more about cGMP, just contact us or send us a query directly.

For lab research only, cannot be used for any clinical use.

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