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Wednesday 21 August 2019
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Why GMP Quality Control is Important in the Pharmaceutical Industry

Good Manufacturing Practice (GMP) is a quality control procedure that keeps chemical manufacturers in check. It ensures adequate tests and dosing for optimal effectiveness of these products. So, why is GMP important?

The GMP standards controls; the ingredients in food and drugs, pharmaceutical products, medical devices, and quality of food. This ensures that a manufacturing firm follows a set of rules and regulations, thus producing a product that meets the necessary quality tests.

The manufacturing process needs to be clearly defined and controlled. In this way, the final product is made per set specifications. During this control process, any change or alteration needs to be checked and analyzed for its effect on quality. Any product that loses quality due to these changes or alternations should be discarded.

The United States, being the largest manufacturer of chemical products globally emphasizes the need for GMP quality assurance procedures. Without it, the country cannot guarantee that its products conform to appropriate quality and safety standards.

For a consumer, the product needs to have clear and understandable instructions that comply with Good Documentation Practices. Further, the instructions should be devoid of confusing or ambiguous language. So, GMP ensures that all chemical products do not pose any risk to the public or the consumer.

What’s the Purpose of Enacting GMPs?

An ordinary buyer cannot, either by smell, touch, or sight detect whether drug, food or cosmetic products are effective or safe for use. One way to determine this is by testing at different production stages. However, this alone cannot guarantee product safety or quality.

Reason being, the manufacturer will only test a sample of like 200 medical devices in a production line of more than one million devices. In this way, the manufacturer can sell so many products to maximize profits rather than sacrificing them for testing.

Therefore, it becomes necessary to draft regulations/guidelines that govern every process, facility, steps or equipment to be used in designing and manufacturing consumer goods. The facilities should be maintained in good working condition, employees should be trained, and the equipment should be validated. Doing this helps maintain accurate, calibrated measurement with a consistent and reproducible process.

How Does GMP Quality Control Differ from Other Quality Control Approaches

As you know, there are many quality control/assurances practices. However, GMP quality control distinguishes itself in that it’s mandatory for producers of goods falling under the Food, Drug, and Cosmetic Act. Others like ISO quality certification, aren’t mandatory, but manufacturers are advised to comply with them.

However, almost all these quality control approaches cover the same standards. The difference is only in the allowable thresh holds. The GMPs will include all the regulations on process validation, Comprehensive Corrective and Prevent Action (CAPAs) good laboratory practice, vendor qualification, and management reviews.

Unlike other quality control measures, failure to comply with GMP quality control will attract immediate sanction for your firm.

How Does GMPs Benefit Manufacturers

Getting a GMP certification boosts their credibility effectively boosting the competitive advantage in the market.

It boosts the senior management confidence as they prepare their facilities for FDA inspection.

Reduces the time and costs that a company spends in hiring a third-party to test their products. The GMP synthesis is a national program that seeks to provide a system of procedures and documentation to guarantee that the final product has the strength, identity, composition, quality, and chemical purity that it is represented to possess.

Conclusion

Virtually anyone living in the United States is affected by the quality of pharmaceuticals. According to Mayo Clinic, over 70 percent of Americans take a prescription drug in a day. The use of dietary supplements and other non-prescription drugs is also widespread in the country. GMP quality control is important in that it ensures that products getting to the market are safe and secure for everyone to use. On their own, customers cannot detect an ineffective or unsafe product by simply smelling, looking or touching the product.




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