ProPack ProPack's Quality Control Systems
Nov 06, 2015

ProPack's Quality Control Systems

Imagine your boss has just told you to find a GMP certified third party logistics facility. Sounds easy enough, but what exactly is a GMP certified facility and why do you need one?

The acronym stands for Good Manufacturing Practices, and to be GMP certified means that the distribution facility has demonstrated a strong regulatory commitment and compliance to international GMP standards enforced by the US Food and Drug Administration (FDA). GMPs provide for quality control systems that assure proper design, monitoring, and control within the distribution facility.

On August 10th and 11th 2015 ProPack’s Utah facility was audited by NSF International for GMP compliance with the end goal of becoming GMP certified.

Now who is NSF you ask? Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment.

The SOPs (Standard Operating Procedures) for ProPack warehouse and order fulfillment services are documented in an organized fashion. These include general principles to guide us down to very specific Work Instructions. These SOPs and Work Instruction documents are fine-tuned and adjusted to accommodate GMPs in order to meet the FDA requirements for holding and distributing packaged food items and dietary supplements.

Below are the quality control systems that guide our processes.

·  GMPsare FDA requirements and guidelines for the holding and distributing of dietary supplements. Basically GMPs tell us what we need to do to comply with the FDA requirements. These are higher level principles and guidelines that direct SOPs and Work Instructions.

·  An SOP is an established or prescribed method to be followed routinely for the performance of designated operations. Basically SOPs tell us what steps we must follow in order to be compliant with GMPs and to perform work correctly and accurately, while still being GMP compliant.

·  A Work Instruction document describeshow to perform a task, and is a more detailed auxiliary document to the SOP. We may need more details than what is described in the SOP which could be client and task specific. A Work Instruction document is present when the SOPs need more detailed instructions.

In short;

-       GMPs are general guidelines to keep our processes within FDA requirements.

-       SOPs tell us the steps and procedures that we as a company follow to meet the GMP requirements. SOPs outline our overall processes.

-       Work Instructions are more detailed than SOPs and are sometimes client and task specific.

ProPack is very proud to announce that on September ? our facilities are GMP compliant with international standards as well as having our Ogden facility NSF certified.

So now if your boss should ask you to find a GMP certified third party logistics facility you can contact us today and a ProPack team member will be glad to speak with you.– 360-322-2555

Written by: Shawn Buck, Quality Assurance Manager

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