The FDA's cGMP guidelines ensure products are produced in a consistent way. That means production should take place in a controlled environment. Quality standards should guide the intended use of products. With the right cGMP software system, GMP compliance can be simple and continuous.
The cGMP regulations are in place to ensure product quality and consumer safety. CGMP compliance requires that manufacturers sufficiently control their manufacturing operations. This includes establishing a strong QMS and robust operating procedures. Manufacturers can determine the best methods of implementing controls.
The cGMP guidelines are minimum requirements. They allow some flexibility for manufacturers. This flexibility lets companies use modern GMP quality systems and approaches to improve quality through continuous improvement.
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