The Importance of GMP Labels

                                 Image: TGA at https://www.tga.gov.au/figure-2-components-medicine-label

Proper labeling, especially in the pharmaceutical world, is crucial. It is important that both consumers, as well as medical professionals, understand exactly which ingredients are included in drugs, as well as the proper form of administration. While this may seem obvious due to advances in technology and clear labeling guidelines, accurate and appropriate labeling wasn’t always available. When it comes to purchasing and consuming pharmaceutical drugs now, products must include a clear GMP label that includes all necessary information.

What is GMP?

GMP stands for Good Manufacturing Practice. GMP is a system that ensures the consistent production and control of consumer goods according to set quality standards. These standards are created and enforced to minimize the risks involved in the production and administration of any and all pharmaceuticals.

The U.S. Food and Drug Administration requires manufacturers, processors, and packagers of drugs, medical devices, and other products to take proactive steps to ensure that their products are safe, pure, and effective for consumer use. This protects consumers from purchasing a product that is not effective, or worse, potentially dangerous. The GMP is an enforced measurement, and companies that fail to comply could see a recall of their products and a seizure of their manufacturing, as well as suffer fines and jail time. Ultimately, the GMP was created to provide peace of mind for manufacturers, prescribers, and consumers alike, brought forth by extensive testing, consistent manufacturing, and clear labeling of a variety of packaged materials.

History of GMP

Establishing the GMP took considerable time and effort from both lawmakers and businesses alike. The GMP was developed largely due to incidents and tragedies that highlighted the need for consistent and systematic regulation. There are a few key regulations and acts that have set the legal standards we now adhere to today. These include:

The Pure Food and Drug Act of 1906

At the beginning of the 20th century, there were no federal regulations. This meant that there was no secure protection for the public against potentially dangerous products. The technology at the time was also much more primitive, meaning we lacked the means to carry out and enforce detailed testing of not only products but also the effects they had on the body and mind.

 

At this point in history, ice was still the main source of refrigeration, milk was unpasteurized, chemical preservatives were uncontrolled, and medicines included harmful drugs. Medicines often contained drugs such as opium, morphine, heroin, and cocaine. There were no restrictions relative to the use of these dangerous and potentially deadly drugs, and often labels didn’t even acknowledge or admit to their presence within a drug.

At this time, there was no way to know what you were consuming, and this was true for both patients and medical professionals. The Pure Food and Drug Act occurred in response to the book “The Jungle,” written by Upton Sinclair, that revealed the horrors of the meatpacking industry.

As the public became aware of the real risks associated with having no regulations, the Pure Food and Drug Act of 1906 established stricter guidelines when it came to the production and distribution of food and drugs.

Drugs were no longer unregulated and had to be sold with labels indicating their exact contents. Food or drug labels could no longer legally include false information or be misleading in any way. This meant that the presence and the exact amount of ingredients needed to be clear, especially when certain dangerous ingredients were used, such as cocaine, heroin, or alcohol. This was the first big step towards the GMP.

The Federal Food, Drug, and Cosmetic Act of 1938

This act continued to expand on the guidelines established by the earlier Pure Food and Drug Act and required that drug manufacturers prove that the content of their products was safe before manufacturing.

Drug Amendment of 1962

This amendment tightened control over prescription drugs, new drugs, and investigational drugs. The effectiveness of manufactured drugs had to be demonstrated and proved before they could be approved for distribution and use. Drug firms also had to submit any potential or real adverse reaction reports to the FDA. When advertising drugs in medical journals, it became a requirement that complete information was provided to the doctors relevant to both the effectiveness and risk(s). This amendment essentially formalized the GMP.

The Fair Packaging and Labeling Act of 1966

This act solidified the role of GMP, especially when it came to labeling. This required that all consumer products be honestly and informatively labeled. This was a huge step in ensuring that both medical professionals and consumers could trust their pharmaceutical products.

Pharmaceutical Labels

As a result of these moments in history and the development of the GMP, pharmaceutical labels are held to the highest standards to protect patients. Labels are required to be concise and legible so it is clear to consumers what the product is and what exactly it is composed of. The GMP also allows medical professionals to confidently prescribe medication to their patients, simultaneously assuring patients that their prescription is safe and effective. It is crucial that all necessary information is provided and that the labels are coherent, as this protects both the physician and their patients.

To meet safety standards, labels are required ​​to explain the type of drug, the brand name, as well as the generic name, dosage details, and clear instructions. The label should also list potential side effects, drug interactions, adverse reactions, and warnings — all tailored to prevent any illness, injury, or death.

Trusting Labels

GMP labels are important for both the consumer and the medical professional. By enforcing this standard, the risks involved in prescribing and consuming medication are low. This is largely due to both parties having a full understanding of what is included in the drug, and the proper way to use it. GMP labels show both parties that strict guidelines and restrictions have been followed. Labeling is crucial in ensuring peace of mind, as well as adhering to safety standards.

Royal Label takes its commitment to GMP labels seriously. With years of experience working with GMP standards, Royal Label understands the importance of properly labeled pharmaceutical products and can produce quality custom labels that meet all FDA and other regulatory agencies’ requirements. 

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