Why Did the FDA Introduce cGMP Standards for Food and Drug Manufacturing?

Why Did the FDA Introduce cGMP Standards for Food and Drug Manufacturing?

The Food and Drug Administration (FDA) holds an extremely important role among other organizations. Being responsible for advancing public health, it must introduce innovations in the food and pharmaceutical spaces.

The story of food and drug manufacturing standards dates back to 1938, with the Food and Drug Cosmetic Act (FDCA). Two sections of the Act, Section 402 (a)(3) and (a)(4), to be precise, discussed conditions in manufacturing facilities. What did they reveal?

  • Food manufactured in most facilities is unfit for consumption.
  • If food is prepared, packed, or stored in contaminated facilities, it becomes adulterated and injurious to health.

FDCA’s discussions were considered vague, and the FDA introduced the Good Manufacturing Practice (GMP) standards in 1969. However, those were also found wanting. What were the concerns raised, and why did the FDA introduce Current Good Manufacturing Practice (CGMP) standards, even modernizing them later? This article talks all about it.

Key Interrelated Concerns during GMP Development

The FDA’s GMP standards became public in 1969, but the organization faced enforcement problems. In general, three broad areas of concern were raised –

  1. Some considered the regulations to be unnecessarily burdensome and stringent. This especially held true in the case of small food manufacturing facilities. As a result, there was no assurance that the food would be safe to consume.
  2. People wanted a more concrete answer for “unsanitary conditions” that contaminate food and make it dangerous for health.
  3. Another group asserted that the GMP regulations had no backing of a law. This made its enforcement challenging.

Since the 1969 GMP regulations failed to specify what exactly a manufacturing facility must do to comply with the standards, there was a need for change.

Drafting the Current Good Manufacturing Practice (CGMP)

As the FDA worked on improving and narrowing down GMPs, people began raising the question – what is cGMP? cGMPs, also known as the current Good Manufacturing Practice, was a fresh set of regulations introduced in 1986 to specify manufacturing standards for food, pharmaceuticals, and medical devices.

The purpose of cGMPs is to make these products safe and effective for public use. For instance – If a pharmaceutical company manufactured a drug called Epinephermine (usually used to treat anaphylactic shock), people could be assured of its safety and efficacy through cGMP compliance.

GMPs and cGMPs differed on at least three main levels –

  • Quality – cGMPs narrow down compliance requirements. Hence, they are a step ahead of GMP requirements.
  • Cost – Being cGMP-compliant required additional investment in terms of technology and testing.
  • Standards – cGMPs allow manufacturers to be up-to-date with the latest standards when compared to GMPs, which define only the minimum requirements.

The current GMPs had clear regulations not just on the maintenance of production facilities but also for equipment, laboratories, process controls, labeling and packaging, and returned products. In a way, companies needed access to good cleanrooms, the kind American Cleanroom Systems specializes in.

A cleanroom was just an engineered space where the chance of finding airborne contaminants was very low. Through active cleansing, the controlled environment offered protection for foods and drugs against easy contamination.

Further Revisions to Meet Modern Needs

At the start of 2002, the Center for Food Safety and Applied Nutrition created a modernization group for the FDA’s cGMP. The primary responsibility of this group was to review the cGMPs and determine if they were in need of modernized touches.

Other than that, the group was also tasked to focus specifically on risk-based quality controls. During its initial research in 2003, the working group concluded that cGMPs needed a modernized touch due to changes in food and science. This was mainly the time when ready-to-cook-and-eat meals were introduced.

This was also the time when Listeria Monocytogenes food allergens were discovered, believed to cause cross-contamination of food. Thus, the ready-to-eat foods required microbial monitoring too. So, in 2004, the working group held three public meetings in this regard. The following modernization opportunities were noted –

  • Specific training of workers and supervisors was made mandatory in areas of food protection, personal hygiene, and employee health.
  • A solid allergen control plan is needed in facilities manufacturing foods with any of the eight major food allergens – eggs, milk, fish, tree nuts, crustacean shellfish, soybeans, wheat, and peanuts.
  • A pathogen control plan in writing is needed from facilities manufacturing ready-to-eat foods associated with Listeria Monocytogenes
  • Written sanitation procedures required for food processor maintenance.
  • Food processing plants must also maintain accurate records of whether they are running in full compliance with FDA regulations. These records should be available for review.

The working group’s modernized touch on cGMPs further made the regulations more stringent and complete. They only made the use of cleanrooms inevitable for every food and drug manufacturing plant. There were guidelines regarding different areas – cleanliness, employee health, sanitary operations, imported goods, environment monitoring, and distribution and warehousing, among others.

The Takeaway

Did you know that currently, the FDA covers over 300,000 restaurants and 35,000 agricultural farms under its manufacturing regulations? The latest revisions to the cGMP standards have promised better product quality, purity, and potency.

The standards are not only effective but also highly flexible. This allows every manufacturer the discretion on how to implement the required quality controls for testing, processing, and design. Over the years, companies have used technological innovations and advancements for continued improvements in product quality.

The risk-based approach is especially the most useful. Today, if any manufacturer does not comply with cGMP requirements, their products are automatically considered to be “adulterated” under the law.