Wellspring Pharma Services

WellSpring Pharma Services is a full-service provider of pharmaceutical contract manufacturing and packaging outsourcing solutions for solids, semi-solids, and non-sterile liquids. WellSpring offers full-service contract cGMP manufacturing, packaging and analytical testing services from a single FDA inspected and Health Canada licensed facility.
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Recent Posts

What Are IQ, OQ, and PQ, and Why Are They Required In The Pharmaceutical Industry?

Posted by Wellspring Pharma Services

Pardon the alphabet soup, but these acronyms identify common terms that you’ll see in many FDA and Health Canada guidance documents, and typically refer to equipment. IQ stands for Installation Qualification. OQ is Operational Qualification and PQ is Performance Qualification.

Before you even get to IQ, OQ, PQ, if you’re acquiring a new piece of equipment, you’ll need design specifications that define exactly what’s in that  piece of equipment. Everything from the type of power source it will utilize to the exact materials used in its construction. 

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Topics: Quality & Regulatory

What is a GMP Certified Manufacturer?

Posted by Wellspring Pharma Services

Imagine this scenario: you work for a pharmaceutical company and have just purchased a product and need to find a manufacturer to make this product for you. Your boss has just told you to find a GMP certified manufacturer. Sounds easy enough, but what exactly is a GMP certified manufacturer and why do you need one?

The acronym stands for Good Manufacturing Practices, and to be GMP certified means that the manufacturer has demonstrated a strong regulatory commitment and compliance to international GMP standards.

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Topics: Quality & Regulatory

What Is A Technology Transfer In Pharmaceutical Contract Manufacturing?

Posted by Wellspring Pharma Services

In our vocabulary, a technology transfer is what happens when a pharmaceutical company wants to change from an existing manufacturing site to a new manufacturing site. More generally, it can also involve the move from one process train to another, or perhaps from one facility to another. Manufacturers often have multiple buildings on a single campus, in which case a technology transfer can simply be a move from building to building. In our particular parlance, a technology transfer always implies a move from some other manufacturer to our manufacturing site.

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Topics: Manufacturing Scale-Up

What’s the Best Way to Scale up the Manufacturing Process for my Pharmaceutical Product?

Posted by Wellspring Pharma Services

Many of the pharmaceutical companies we work with initially contact us with questions about scaling up the manufacturing process for their products.  With the bright promise of ramping sales and distribution up comes the immediate challenge of identifying the best place to begin.  We’ll take a close look at the most important considerations of the scaling process in this article.

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Topics: Manufacturing Scale-Up