I need an insight about GMP. I'm just new to manufacturing. I'm sure most companies are aware about the needs for quality assurance of their products. But, why do manufacturers still need GMP and its certification? How can we comply with the regulations easily?
GMP's or Good Manufacturing Practices are essential to the performance of meeting expectations. Certification allows the buyer confidence that such expectations will be met.
Training of employees to perform under GMP's assures consistent and safe manufacture with no arbitrary judgment on their part about what defines "Good"
As a Contract-Packager I work with GMP's everyday. Medical devices are different than coupons and premiums or even actual foods. Having properly defined methods of manufacture makes it possible to produce these various products with a certainty of consistent and and safe delivery of an unadulterated product. And in doing so, meet the expectations of the customer.
It's not just about being clean either. It is about being organized to repeat manufacture with the same identical outcomes. And it is amazing what an outside observer will see. We learn something new and useful at every annual audit. And that made it easier to meet and follow GMP's
What business are you in? Who is the certification agent. Because we do food, cosmetics and medical, I use AIB international.
There is ISO as well
Many years ago, My company was the first in our industry niche to produce and publish written GMP's. Immediately after, we seldom had to deal with customer audits. But General Mills, Ralston Purina, Nestle, and Con Agra still checked us once a year. Once we had AIB certification, no one ever came to audit.
Save a lot of time and headaches. Especially since each of those companies had a different perspective of what was acceptable. AIB certification met one standard they would except.
The Development of Food GMPs
Food safety has been regulated since the mid-1800s and was mostly the responsibility of local and state regulators. However, the Pure Food and Drugs Act, passed by Congress in 1906, marked the first major federal consumer protection law with respect to food processing. The 1906 law prevented interstate and foreign commerce in misbranded or adulterated foods, drinks, or drugs. The intent of the Act was to prevent poisoning and consumer fraud. As more food products were manufactured in subsequent years, however, poor-quality food products and deceptive packaging continued to be produced due to loopholes in the law. Consumers were often unaware of what they were buying until products were opened. Therefore, in 1933, the FDA decided to overhaul the 1906 Act.
https://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110907.htm
GMP's make you company better. Get with AIB or Underwriter's Laboratories for an audit. They have on Line training which may get you certified. Most companies will pay for it. Use 'em.
