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GMP | General Manufacturing Practices | 5 Important FAQ

March 23, 2021

What is GMP?

gmp

            GMP stands for good manufacturing practices. It is a set of regulations put in place to ensure that product quality is consistent and controlled.

Another purpose of GMP is to minimize the risks involved in production. These regulations are required to be followed in the food, beverage, pharmaceutical, dietary, medical, and cosmetic industries in order to provide the customer with a safe and effective product. This is done by ensuring that the quality, identity, strength, and purity of the substance in question match industry standards.

When put in place, this system greatly reduces the risk of contamination, mix-ups, deviations, failures, and errors in the system. Poor quality items not only waste the money of both the producer and the consumer; they are also a health hazard. 

Some refer to it as cGMP – Current Good Manufacturing Practices – in order to remind producers that the equipment that was considered adequate twenty years ago no longer meets the standards. In most countries, GMP standards are controlled by the government, who is authorized to commit unannounced inspections. The regulating body for the United States is the FDA – Food and Drug Administration.

What are standard GMP practices?

            The World Health Organization standardizes good manufacturing practices as follows. Manufacturing shall be done in a clean and hygienic area. Manufacturing plants must maintain controlled environmental conditions to prevent cross-contamination with allergens that would render the product unusable.

All processes must be clearly defined and validated before they begin. Any changes must be approved beforehand and those that negatively affect the quality of the drug must be validated. Instructions and procedures must be written in clear, unambiguous language in accordance with good documentation policies.

Operators of machinery must be trained to document them. Records must be made, either manually or electronically, that document that each step required by the procedures was performed and that the quantity and quality of the drug is as expected. Any deviations from the standard must be investigated immediately. Records of manufacture and distribution must be clear enough to document the entire history of a given batch.

These records must remain easily accessible. Distribution must minimize the risks to quality. There must be a system for recall of any batch or supply. Complaints about products must be examined. The causes of any defects must be investigated and measures must be put in place to prevent recurrence. Even if there is a quality control laboratory, GMP is still necessary.

 Quality can not be added in after the process is completed; it must be a part of the creation process. Without GMP, it is impossible to ensure that quality is consistent with the units tested. These requirements are used in over one hundred countries, primarily in the developing world. The European Union and United States’ requirements are very similar.

Why are they important?

            Consumers by themselves cannot ensure that a product is safe and effective by looking, touching, smelling, or tasting it at home or in the store. Instead, they rely on the manufacturer to provide them with quality products that work. Batch testing doesn’t always work. In a batch of two million tablets, usually around a  hundred will be tested.

Just because the one hundred pass doesn’t mean the other 1,999,900 will. Testing all of them is impossible, as testing results in the destruction of the sample. As a result, quality can’t be added at the end. Quality must be a part of the production process.  GMP practices not only ensure workplace safety, but also make sure that customers receive safe, effective, and high quality products. These practices also benefit the manufacturers.

Calibrated and documented measurements ensure that production processes are easily replicable later on. Poor quality goods also waste money and materials – consumers will always go for higher quality. Complaints about spoiled goods or cosmetics not working properly siphon manpower away from manufacturing to manage teams controlling recalls and refunds.

Consistent complaints from customers regarding products can also damage a company’s reputation. Good quality goods, on the other hand, are far less likely to be recalled. Following good manufacturing practices also boosts a company’s export potential as different countries may have stricter policies.

Who enforces them?

            The regulating body for GMP differs by country. In the United States of America, it is the Food and Drug Administration. In Canada, inspections are carried out by Health Products and Food Branch Inspectorate. In the United Kingdom, the Medicine and Healthcare Products Regulatory Agency handles quality control.

India’s Food and Drug Administrations reports to the Central Drugs Standard Control Organization. The European Union has individual National Regulatory Agencies manage requirements. The Therapeutic Goods Administration of Australia controls GMP. Almost all of these are authorized to perform unannounced inspections during any time the business is open. However, some of these inspections are scheduled. Failure to meet the standards can result in product recall, fines, seizure of the plant, and even prison time. New companies should check with their federal regulating body for information on GMP requirements and documents.

If manufacturers aren’t following GMP, are the products still safe to use?

 Products that are produced in violation of GMP are considered adulterated under the law. This does not always mean that the product is unsafe to use, only that it was manufactured without adhering to the GMP standards. A drug manufactured in violation may still meet its labelled requirements and the risk of unsafety remains minimal.

The FDA (or other regulating body) will provide information and next steps based on the severity of the violation. Do not stop taking prescription medications without first consulting a medical professional, as the consequences may be dangerous for your health. Instead, talk to them and see if you can switch to a GMP-compliant regimen. In some extreme cases, the FDA may request that the drug be recalled.

They cannot force the company to recall the drug, but if the company refuses to comply, the FDA is legally allowed to seize the drug and warn the public.

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