Good Manufacturing Practice (GMP) Certification & Its Importance

The GMP certification is a  voluntary certification program that recognizes manufacturers who consistently produce safe and high-quality products. The GMP certification is recognized by regulators and consumers as a mark of quality.

GMP stands for Good Manufacturing Practice. GMP is a set of guidelines that detail the procedures and processes that should be followed in order to manufacture safe and high-quality products.

GMP verifies that your products are manufactured in a clean and safe environment, that they are free of contaminants, and that they meet all quality standards.

The GMP certification is a voluntary program, but it is well worth the effort to obtain the certification. The GMP certification is recognized by regulators and consumers as a mark of quality.

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The History of GMP

GMP certifications were formed as a means of consumer protection. GMP certifications were formed as an extension of FDA approval for products. 1962 was the year in which the FDA introduced drug amendments and the formalized certification known as the GMP. Since 1962 the certification has been amended numerous times in response to large-scale events, with one of the most notable amendments occurring in 1983 after over-the-counter Tylenol was found laced with cyanide.

The GMP certification program was created in the aftermath of several tragic events that killed or injured many people. These events demonstrate the need for stricter regulation of the manufacture of medical products.

GMP certification is now required for all manufacturers of medical products, and it’s recommended for anyone producing consumer goods. The GMP certification is a way of ensuring that the products you use are safe and effective.

Covered Under the GMP

A good manufacturing practice certification includes every piece of the production process.  All materials, equipment, staff, and processes must meet GMP standards.

GMP Covers

  1. Raw materials: All raw materials must be of high quality and free of contaminants.
  2. Equipment: All equipment must be clean and well-maintained.
  3. Processes: All processes must be documented and followed exactly.
  4. Staff: All staff must be trained and follow good hygiene practices.

GMP certification is a way of ensuring that products are manufactured in a safe and high-quality environment. GMP standards cover all aspects of the production process, from raw materials to equipment to staff. By obtaining GMP certification, manufacturers can show regulators and consumers that their products are of the highest quality.

Each time a company produces a new product, they need to also generate a written procedure and documentation for every task in its production.  This is to ensure that each batch meets quality standards. If a product doesn’t meet GMP standards, it could risk the chance of being rejected for FDA approval or being recalled for a quality issue.

Why do manufacturers choose to work with suppliers carrying a GMP certification?

There are several reasons why it’s beneficial for manufacturers to partner with suppliers that hold a GMP certification.

GMP compliance is required by law: If you want to sell your products in Asia, US, Canada or Europe, you will need to comply with GMP standards. These standards are put in place to protect consumers from subpar or dangerous products.

A GMP certification is a sign of quality: A GMP certification is an internationally-recognized symbol of quality. When you partner with a supplier that holds this certification, you can be sure that they are committed to producing high-quality products.

GMP compliance ensures product safety: One of the main goals of GMP standards is to ensure that products are safe for consumers. By partnering with a GMP-certified supplier, you can be sure that their products meet these safety standards.

GMP compliance saves time and money: If you partner with a supplier that is not GMP certified, you may run into quality issues down the line. This could result in costly delays or product recalls. By partnering with a GMP-certified supplier, you can avoid these issues and save time and money in the long run.

When choosing a partner for your manufacturing needs, look for one that is GMP certified. This certification is a sign of quality and commitment to producing products that are verifiably safe for the market.

Why are GMP-certified products better for consumers?

Even if you are not in the drug or supplement industry, receiving a GMP certification for your product will make sure that consumers will verify that your product is following the same stringent standards that a drug requires to get FDA approval.

When your product carries the GMP certification badge, your customers will know that you care about product quality and safety. Furthermore, they will also know that an independent, third-party has verified that your claims are accurate.

The certification ensures that your product is safe and effective, every process is monitored and the contents of your product will be uniform. This is especially crucial in the food service, supplement, or pharmaceutical industries to ensure proper ingredient listing, dosage, and more.

What happens if a product does not qualify for a GMP certification?

If a product is unable to meet the standard for GMP regulation, action needs to be taken based on how severe the violation may be.  A voluntary or mandatory recall may happen for the product. The company would also have to investigate how the error occurred and put corrective measures in place to prevent it from happening again in the future.

If the product is a pharmaceutical or supplement, it is likely the product will not receive FDA approval, so the company will stop production completely to address the problem. This can often lead to a complete redesign of the product to improve standards.

In extreme cases, if a manufacturer receives a request from the FDA or the auditor reviewing their GMP certification, an injunction or seizure of the product can occur. In these instances, the company will have to cease and desist all production of the product and may have its means of production or formula confiscated as the product and process endanger human health.

By having a GMP certification, you, as the consumer, can be sure that the products you are taking are safe and effective. If you are interested in receiving this certification, contact a local auditor who can take you through the process.

If you are looking for a GMP consultant, please contact us to find out more info.

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