What Is The Difference Between Method Verification And Method Validation?

Posted by Wellspring Pharma Services

Clients have come to us in the past asking "We need 'method validation'.” Sometimes they'll use the term “validation” or “verification” but it seems apparent they're not really clear on what the difference is between the two. For the most part it’s not that well-known that method validation is a much more rigorous process. What’s really needed, more likely, is the establishment of a verification regime that assures analytical methods perform reliably, accurately, and precisely for its intended application.

more

Topics: Quality & Regulatory

Good Manufacturing Practice: The DNA of Pharmaceutical Quality

Posted by Wellspring Pharma Services

Good Manufacturing Practices or GMP's are the pharma industry’s fundamental guidance set up by regulatory authorities to describe what is necessary to manufacture safe, effective drugs. Essentially, GMPs (referred to as current Good Manufacturing Practices or cGMPs in the U.S.) provide a framework of manufacturing best practice standards that pharmaceutical processors are compelled to adopt and incorporate into their drug-making processes.

more

Topics: Quality & Regulatory

How Do You Set Up A Quality Organization?

Posted by Anelis Aurand-Araos

In order to set up a quality organization, the organization must have a culture of quality. Survey findings in the Forbes Insights-ASQ white paper published in fall of 2014 offer research findings which help illuminate what quality culture means to organizations globally.

more

Topics: Quality & Regulatory

What Is The Best Way To Keep Up With Changes In FDA Standards?

Posted by Anelis Aurand-Araos

This is an interesting concept, one that actually goes by the name of “Regulatory Intelligence.”  Regulatory Intelligence (RI) is something that's really important because the standards are always evolving. In the United States, for example, they start at the top with the Federal Food Drug & Cosmetic Act, and recently, the Drug Quality and Security Act of 2013. FDA takes these laws and promulgates regulations and guidance documents to interpret those regulations.

more

Topics: Quality & Regulatory

What Product-Life Cycle Management Strategies Could Be Used To Extend The Life Of A Pharmaceutical Drug?

Posted by David Watt

Name brand (Innovator) pharmaceutical companies must extend the product life cycles of drugs to maintain profits, exclusivity, market share and transition into next generation products. Patent protection is crucial to the innovative pharmaceutical industry. Innovative companies require the guaranteed period of market exclusivity to sustain drug prices, recoup research and development costs and to fund the development of new products or next generation drugs.

more

Topics: Quality & Regulatory

What Are My Options For Reducing My Pharmaceutical Product Manufacturing Costs?

Posted by Wellspring Pharma Services

We’re often presented with the challenge of reducing the manufacturing costs of a pharmaceutical product. There are several avenues to take in reducing your product costs - so let's take a look at a few areas that can be re-evaluated for potential savings.

Look At Your Individual Raw Material Costs, And How They're Supplied

more

Topics: Quality & Regulatory

What Are Some Helpful Ways To Ensure A Successful Pharmaceutical Product Launch?

Posted by Michelle Puglielli

A great pharmaceutical product starts out as a great idea that will ultimately provide a safe solution to a common problem, where it is beneficial, convenient, and worthwhile for your customer to purchase. Whether it be in a tablet, capsule, semisolid, or non-sterile liquid form, your product must prioritize the needs and demands of your therapeutic area and demographic to achieve a sense of improvement and resolution to your customer’s day-to-day life. Your product must be proven to work, in demand, and most importantly, exhibit the uppermost quality and safety.

more

Topics: Quality & Regulatory

How Do You Choose The Right Contract Manufacturer For Your Pharmaceutical Product?

Posted by Wellspring Pharma Services

Pharmaceutical companies face a critical decision in choosing the right contract manufacturer for their product's success and ultimately for their company’s performance.

While price is an important consideration, there are many other factors to consider, and in our experience, we have found that it may come down to a lot more than who can manufacture most economically.

more

Topics: Quality & Regulatory

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. 

more

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.

more

Topics: Quality & Regulatory