Are you new to the concept of Current Good Manufacturing Practices (cGMPs)?

IriSys’ experienced formulation development scientists and manufacturing unit work together to optimize the formulation and scale-up for the cGMP manufacturing of clinical trial materials and commercial pharmaceutical products. The cGMP manufacturing team complies with IriSys’ rigorous Standard Operating Procedures and FDA Guidelines.

The Facts About the Current Good Manufacturing Practices section of the FDA website has good introductory information and explanations.  A selection is below.

https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm

Pharmaceutical quality affects every American. FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of CGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of CGMPs. This paper discusses some facts that may be helpful in understanding how CGMPs establish the foundation for drug product quality.

What are CGMPs?

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for 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 assures that drug products meet their quality standards.

Also see at this FDA link…

Why are CGMPs so important?

How does FDA determine if a company is complying with CGMP regulations?

If a manufacturer is not following CGMPs, are drug products safe for use?

What can FDA do to protect the public when there are CGMP violations?

How would a new drug company learn about CGMPs and about FDA’s expectations on complying with them?