Current Good Manufacturing Practices (cGMP)

Cyclomedical represents 45 years of experience producing, qualifying, and validating radiopharmaceutical drugs.  We keep in close touch with regulators in the US and with new developments in US, European and other pharmacopeias.  We can guide you in how to prepare your facility for what is to come in regulations for production, documentation, and distribution. 

What are CGMPs?

In the US, cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (USFDA).  CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities, starting with good housekeeping.  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.  Many countries have legislated that food and pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation. 


Also in the US, PET drugs have their own special section in the regulations, reflecting that they are a type of diagnostic drug with unique characteristics that warrant special considerations. That section can be found at:


eCFR as of October 30 2015 Title 21Chapter ISubchapter CPart 212Subpart A → §212.2  PART 212—CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS


GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.   It is important to note that CGMPs are minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.


The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.