GxP: Assuring Drug Safety and Compliance

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For the first entry in my new Blog, we will begin at the beginning with GxP. (See why I blog)  What exactly is GxP? As you may be aware, the US Government has Codes of Federal Regulations (CFRs); lots of them. In the world of food and drugs the regulatory body is the Food and Drug Administration (FDA), and like all good US Government administrations, the FDA has its own bunch of CFRs.  

The FDA CFRs that govern drugs are Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). Since all of these acronyms start with a ‘G’ and end with a ‘P’, and since most people have taken algebra, industry professionals have cleverly substituted the middle letter with the variable ‘x’ (presented in lowercase to accentuate the point). Sometimes it is also written as cGxP, which means ‘Current’ Good [whatever] Practice.

On the automation and controls side of things, the points of intersection between GxP and the automation of the process are the “GxP-regulated Computerized Systems”. These computerized systems are defined as the systems that keep the algorithm and control information directly related to GxP (such as recipe set points and values to be used in making a drug product, or stored batch data that is to be retained for a drug product). A general statement that can be made is that Computerized Systems are considered to be under the governance of GxP if they impact - or have the potential to impact – patient safety through product quality, integrity, purity or potency.

Take a look at www.fda.gov and you will find a very well organized and user-friendly website. The FDA’s CFRs are called ‘Title 21’ and Title 21 (or 21 CFR) is divided into many parts. For now, we will focus on the Good Manufacturing Practice (GMP) parts. The main Title 21 parts of concern in the BioPharma Manufacturing world are 21 CFR Part 11, 210, and 211 (There are a few others, but for this Blog Entry we will focus on these.) Here is a snapshot of each:

Part 11: ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
The primary thrust of Part 11 is that if a company chooses to keep records of drug manufacturing (i.e., Batch Records) that they be “trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.” Electronic records must also be secure, so there is a section of Part 11 that focuses on security.  

Part 210: CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
Part 210 provides the “minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.” In layman-speak the above quote means that the patients are ‘safe’ when they take the drug, that the drug has the correct ingredients and properties it is supposed to have, and that it will consistently do what it is supposed to do. Part 210 does not have specifics directives to a drug company; it mainly provides a preamble and a list of definitions.

Part 211: CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Part 211 provides the “minimum current good manufacturing practice for preparation of drug products for administration to humans or animals.” This is where the ‘meat’ of the GMPs live. It would definitely be worth your while to go through this one. There is one very important thing to note when talking about this particular CFR and its subparts: the FDA tells you what they want you to do, but does not tell you how to implement what they want.  
               

Neal Collier
Bio-Pharma

About the Author

Neal Collier is a Principal Engineer at Avanceon, where he leads Pharmaceutical Project Teams in GxP-compliant integration solutions and validation efforts. Neal has worked on many different PLC and DCS controls platforms - and their associated HMI or SCADA visualization packages - utilizing complex programming methodologies and strategies.

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