"Validation" or "Qualification" – What’s the difference?

I face this question on a regular basis from my clients, both internal and external. So what is the difference between qualification and validation?

Topic: Qualification / Validation, Topic: GMP Biol..........

Personalized Medicine and Validation of Next-Generation Sequencing

Personalized medicine and next-generation sequencing (NGS) are two trends producing major swings in the healthcare industry. As previously discussed on Doe & Ingalls blog, here are some points you should be familiar with if your strategy touches upon either of these.

Topic: Qualification / Validation, Topic: Laborato..........

Large-Scale Freezing of Biologics: Advantages and Challenges

Biopharmaceutical companies often produce millions of units of bulk biological materials that are then distributed for clinical use. This represents a significant supply chain challenge, as these materials need to be maintained within very specific environmental parameters. Temperature, humidity, and stress during material handling must be tightly controlled to prevent degradation of quality. Large-scale freezing of biologics provides a safe and effective method of storing biological materials, but this approach comes with unique challenges.

Topic: Biobanking and Biorepository, Topic: Cold-C..........

The Four Stages of Equipment Qualification

As discussed in my previous blog, qualification is the process of establishing documented evidence that a specific equipment, facility or system are fit and ready for their intended use. It establishes confidence that the equipment in a biorepository is capable of consistently operating within set limits and tolerances, and allows for conduction of tests to be performed on one element or component of the process to be validated against a specified outcome.

Now that we have a better understanding of the difference between Qualification and Validation, let’s expand our knowledge of the four equipment qualification stages.

Topic: Qualification / Validation, Topic: GMP Biol..........

The Importance of Freezer Qualification for Biologics

For those studying, manufacturing, or experimenting with delicate pharmaceuticals and biological samples, the importance of storage and accurate temperature monitoring is well known. From a qualification and validation perspective, the equipment and processes used for shipping, storing, and other services must comply with the products’ requirements throughout the chain of custody.

In this two part blog series I will convey the importance of qualifying the equipment and validating the processes through which your valuable biological material is managed.

Topic: Qualification / Validation, Topic: GMP Biol..........

Accidental Freezing of Vaccines

When discussing the impact of temperature on vaccines, heat is the better-known hazard. However, while the vaccine cold chain is a way to protect vaccines from inactivation associated with high temperatures, exposure to low temperatures can also result in potency losses. In a 2007 study, researchers found that vaccines were exposed to freezing temperatures in 14 to 35 percent of refrigerators or transport shipments. Thus, accidental freezing of vaccines poses a significant and growing threat to national immunization programs. And in locations where the equipment is not qualified or the process is not validated, the impact of environmental temperatures on the vaccines could be significant.

Topic: Cold-Chain Logistics, Topic: Qualification ..........

Why GMP? An explanation of Good Manufacturing Practice

GMP refers to the Good Manufacturing Practice Regulations published by the FDA under the Federal Food, Drug, and Cosmetic Act. As a response to concerns about substandard drug manufacturing practices occurring at the time, Congress enacted the 1962 Drug Amendments. These amendments instructed the FDA to require all drugs to be made according to Good Manufacturing Practice (GMP) as defined under FDA 21 CFR Part 210-211.

The first set of Good Manufacturing Practices (GMP) regulations were published in 1963. These regulations are meant to guide companies in the production of safe and effective drugs. The regulations outlined in the GMPs are the minimum requirements necessary to ensure safe and effective products.

In this blog we'll discuss the definition of GMP, various regulatory components, and why it's important for companies in the life sciences space.

Topic: Biobanking and Biorepository, Topic: Qualif..........

Implementing Pre-qualified Shippers into Ambient and Controlled Room Temperature Operations

Whether you are working with cell therapies, biologics, drug product, or biospecimens, temperature is an omnipresent concern that requires your attention. From a logistics standpoint, maintaining appropriate temperature conditions is of utmost importance to ensure your material arrives at its final destination with its integrity intact. Therefore, it is no surprise that within our industry the definition of cold chain is expanding beyond cold temperatures to include both ambient and controlled room temperature (CRT) shipments.

Topic: Cold-Chain Logistics, Topic: Qualification ..........

First Pass Yield or Quality Yield, Wait… What’s the Difference?

Manufacturing-related quality statistics aren’t normally associated with biorepositories, but the world of statistical process improvement tools can be very useful for biobanking. One such case is the difference between two basic statistical metrics — Quality Yield and First Pass Yield.  I'd like to shed some light on both metrics starting with their definition, then propose a recommendation of which to use in a biorepository setting, and conclude with a proposed performance target level.

First Pass Yield vs. Quality Yield

Quality Yield (QY), also known as Final Yield (FY)1 represents the acceptable pieces at the very end of a process divided by the original number of pieces fed into the process. In a manufacturing setting, this tells you the overall proportion of acceptable results; if the number of units of acceptable quality at the end of the process is the same as what can be expected given what is fed into the process, then you have achieved a 100% Quality Yield.1

Topic: Biobanking and Biorepository, Topic: Qualif..........

The Case for Qualification and Validation of Biological Material Storage and Transit Systems

qualification and validation shipperHow much is your lack of temperature control costing you? Too often vaccines and bio-therapeutics are destroyed because of improper storage and distribution. And lost inventory is only the beginning of the true cost of not maintaining cold chain. Meeting ever more stringent regulatory requirements will become more difficult without taking the steps needed to qualify or validate your storage and transit systems. If you get 99 percent of your cold chain right but miss on the final 1 percent, you still fail, especially where cell-based products are involved. And the reason is most likely excess complexity, which is especially true for managing newer biologics such as an autologous cell therapy that requires the patient's sample to formulate the final therapeutic agent. 

Topic: Qualification / Validation, Content: Blog

Qualification and Validation Webinar: How to Manage Cold Chain Qualification When Handling High Value Biologics

As cold chain and ultra cold chain logistics have become an increasingly important element in the shipping of high volume medical, biologics, and other critical biological materials. The need to create an effective strategy to ensure packaging integrity has become a topic of great interest. 

Topic: Qualification / Validation, Content: Webina..........

Cold Chain Qualification : 5 Questions You Must Ask When Shipping Biologics

“Cold Chain” refers to the undisrupted series of logistical activities (packaging, shipping, storage, distribution, handling) of products that must be maintained within a given temperature range. And as those of us in the biopharmaceutical industry know well, maintaining cold chain is critical to the integrity of biologically derived therapeutic products.

Topic: Qualification / Validation, Content: eBook