GMP Certification: Why Get GMP Certified With CfPIE?

Process standardization is one of the most important factors to ensure consistency in manufacturing. And when it comes to manufacturing drugs, medical devices, skin products, and cosmetics, consistency is everything.

Manufacturers in the pharmaceutical industry must familiarize themselves with the international Good Manufacturing Practices (GMP), the official standards set by the FDA to specify drug quality based on the compliance level of the producer.

Most drug consumers have no way of verifying the effectiveness of their medications, so these practices function essentially as consumer protection. Becoming GMP-certified is one of the best steps you can take as a pharmaceutical manufacturer for several reasons.

Read on to learn why your facility should obtain a GMP certification from CfPIE.

The Key Benefits of a GMP Certification

Any facility looking to follow best practices should seek out a GMP certification. It’s one of the easiest ways to demonstrate your commitment to consistency, current regulations, and to build confidence with your customers.

Here are a few of the main reasons why a GMP certification is a worthwhile investment:

• Promote proper quality control:Undergoing the GMP process means that your manufacturing is consistent and aligned with the best industry practices and that your advertising is accurate to the product you are selling.

• Enable process validation:Companies with the certification have their plants constantly monitored and controlled at all times and have positive administrative protocols as well, such as worker sanitation, personnel qualification, and record keeping.

• Prevent cleanliness issues:Contamination with allergens or other harmful materials is a common issue for the pharmaceutical industry. GMP-compliant organizations always have hygienic work areas with controls in place to prevent cross-contamination.

• Ensure legal compliance:This international standard shows any regulatory agency, from the US’s FDA to the EU’s EMA, that you take pharmaceuticals seriously and can proactively ensure compliance with high standards of manufacturing.

• Promote a positive reputation:Drug companies will always look for GMP certification when choosing a manufacturer to produce their products. Customers likewise will see the FDA approval as a sign that the product is held to high standards and worthy of consideration.

• Build an incident response system:GMP requires companies to have established protocols in case mistakes occur. Records must be made of each step in the manufacturing, and all infractions must be documented. A recall system is also mandatory so that defective batches can be withdrawn from sale and appropriate measures can take place to prevent future incidents.

• Stay up-to-date:Medical technology is always advancing, so it’s also worth taking into account current Good Manufacturing Practices (cGMP). This specification shows that not only are your processes aligned with GMP guidelines but also that they use the most up-to-date methods available.

How to Get GMP Certified?

Interested in learning more about ourGood Manufacturing Practices certification? CfPIE offers its own facility certification program to streamline the GMP process.

We send our own staff to your factory floor to complete physical checks and auditing. From laboratory quality control to proper administrative practices, we will independently evaluate and ensure the compliance of your business and even offer remediation suggestions if we find any weaknesses.

You’ve seen the benefits that such a certification brings to your organization, so get in touch with us today. Our multi-step process begins with a Discovery Session over the phone or web conference.