Pipette acquiring a sample in a laboratoryThe United States’ Food and Drug Administration (FDA) is the federal government’s oldest consumer protection body, having existed in various guises and with varying responsibilities since 1848. In its modern incarnation the FDA has had an overarching responsibility to ensure the quality and integrity of food, drugs and other consumer products. As the roles and responsibilities of the FDA have evolved over the years, so too have the FDA laboratory regulations.

What you should know about FDA Regulations

The FDA is responsible for regulating drugs (both for human and animal use), medical devices, and biological products, such as vaccines. The FDA also regulates food (other than meat and poultry), cosmetics, animal feedstuffs, and certain classes of radiation-emitting products, such as those used for medical purposes. The FDA has regulatory oversight during a medical product’s entire product lifecycle, from clinical trials to manufacturing, and from product labeling to registration.


The History of Drug Regulation

There have been numerous milestones in the history of drug regulation in the USA, beginning with the initial development of a US Pharmacopeia in 1820, the first compendium of drugs in the United States. Other milestones in the subsequent decades included the original Food and Drugs Act in 1906, and the formation of the FDA in 1930.

The need for improved drug safety legislation was graphically and brutally illustrated in the so-called ‘Elixir Tragedy’ in 1937. Elixir Sulfanilamide, an untested compound used to treat a variety of conditions, from sore throats to gonorrhea, killed 107 people, many of them children. The Elixir, it turned out, contained the toxic substance diethylene glycol. The Federal Food, Drug, and Cosmetic (FDC) Act, containing many new and much stricter provisions for drug safety, was passed by congress the following year, and the era of the laboratory test for pharmaceutical products was underway.

The 1970s saw improvements to medical product labeling and better information for patients about a given drug’s risks and benefits, while in the 1980s legislation was passed with regard to tamper-resistant packaging for medicines. The information technology revolution in the 1990s led to the consolidation of various databases for reporting adverse effects from medical products, along with the most wide-ranging reforms in the FDA for decades, following the introduction of the Food and Drug Administration Modernization Act (FDAMA) in 1997.

Changes to the FDA have continued during the early part of this century, such as an act designed to increase the USA’s ability to prevent and respond to public health and terrorist emergencies (the Public Health Security and Bioterrorism Preparedness and Response Act of 2002). Also in 2002, FDA laboratory regulations were updated to improve current good manufacturing practice (cGMP) to enhance the regulation of medical products and their manufacture.


Guiding principles of current FDA regulations

One of the major challenges for pharmaceutical companies is to keep track of and stay up to date with the frequently changing FDA laboratory regulations. The FDA suggests some guiding principles it strives for when overseeing or advising on cGMP guidelines, which are:

  1. Strong public health protection
  2. A risk-based orientation
  3. Science-based policies and standards
  4. Integrated quality systems orientation


The reason behind the first of these guidelines is self-evident, since public health protection should clearly be at the forefront of all testing and regulatory protocols used during the development and manufacture of pharmaceutical products.

The second guideline, having a risk-based orientation, aims to identify potential risks in the pharmaceutical development or manufacturing process at the earliest available opportunity. This then enables the implementation of any corrective actions that may be necessary.

Third, the emphasis on science-based policies and standards is part of the trend globally since the 1960s to move toward an evidence-based approach to drug design and pharmaceuticals manufacturing, both to increase the efficiency of drug development and to decrease the risk of adverse events. The FDA played a key role in this move, advocating for the role of evidence-based approaches to food and medicine safety and efficacy, and implementing the 1962 amendments to the Federal Food, Drug, and Cosmetic Act. Prior to this evidence for a drug’s efficacy was often poor or lacking entirely, and many drugs were marketed on the basis of false claims.

The fourth of the FDA’s guiding principles – the requirement for integrated quality systems – brings us right up-to-date, with the need for cutting edge, automated laboratory-monitoring systems.


Simplifying compliance with FDA laboratory regulations through automated systems

Comprehensive, integrated pharmaceutical laboratory monitoring and reporting systems are becoming increasingly sophisticated, and offer automated, streamlined ways to monitor pharmaceutical lab processes throughout every step of a product’s manufacturing process. Data submitted to such a test system can be quickly and readily analyzed, with the system automatically flagging up any issues that may require corrective actions. These systems can monitor a range of critical data submitted to them, from raw data and product storage information to production line data, and from ambient laboratory variables to the integrity of standard operating procedures.


XiltriX is a comprehensive, integrated laboratory monitoring and reporting system that can help automatically generate reports and keep up with rapidly changing FDA laboratory regulations. XiltriX also offers support for the validation processes required in today’s regulatory environment.

XiltriX installations are in laboratories operating in heavily regulated environments, where system validation is an essential part of the implementation. To meet the highest quality standards, on request, XiltriX can provide the functional specification documentation to ensure validation is is in the right place. The system can be fully validated and is compliant with all appropriate quality and regulatory standards: GMP, GLP, GxP, FDA 21 CFR part 11, CAP, CAPA, HACCP, JCAHO, USP 797, etc.


As noted above, there are myriad regulations that laboratories must adhere to, particularly GxP facilities. One such regulation, FDA CFR 21 Part 11, covers electronic records and electronic signatures in conjunction with systems implementations. The XiltriX system is adherent to this regulation for any facility aiming to implement a laboratory monitoring solution. There are several other regulations to consider when adopting a system like XiltriX.


5 Important FDA Regulations to Consider when Implementing a Monitoring Solution


FDA Laboratory Regulations



When a life science organization takes these regulations into consideration, aims to implement a lab monitoring solution such as XiltriX, and utilizes the various automated reports it can generate, customers will have easily available proof to demonstrate that their pharmaceutical lab is in compliance with all relevant FDA laboratory regulations whenever a laboratory inspection or audit is undertaken.


Learn more on how to ensure best lab practices are followed in our white paper:

Pharmaceutical Drug Development