Good Manufacturing Practices

Good manufacturing practice (GMP) AND OUR APPROACH

Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.

Why GMP is important?

It refers to the standards set by the United States Food and Drug Administration, more commonly known as the FDA. GMP regulations require that the processes, by which products are made, as well as the products themselves, are effective, safe, and pure. GMP regulations also require that the manufacturers take care to avoid contamination, errors, and mix-ups. All of these regulations ensure that the customer gets a product that is what they want to buy and is not dangerous.

GMP is also often referred to as “cGMP,” which simply stands for “current Good Manufacturing Practices.” Although not necessary when referring to GMP certification, the “current” references GMP’s requirement that manufacturers be up-to-date with their practices and procedures. GMP regulations even control the training of employees, ensuring that not only is the technology current, but the employees are knowledgeable and up-to-date on industry practices and information. Companies are audited for adherence to GMP regulations on three levels: self, internal, and external. The self audit, as the name suggests, is done by the individual performing a task. If a manufacturer is inspected by the FDA, or the Natural Products Association, or NSF International and found to be in compliance with all GMP regulations, they are referred to as GMP certified. When choosing a supplement manufacturer, it is absolutely essential that you select one that is GMP certified. This means that they are in compliance with all the GMP regulations.

Why Arrelic for GMP Consulting?

Not only do we adhere to all FDA GMP policies, but we have third party certifications through both the NPA (Natural Products Association) and NSF International (a not- for-profit non-governmental health organization). This proves our dedication to constantly search for ways to improve and enhance our capabilities.

  • Arrelic is the only Certified Consulting Company to provide GMP certification in eastern and central region of India.
  • Just not only giving you a GMP certificate we also optimize your process with most cost effective way.

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