How Do You Set Up A Quality Organization?

Posted by Anelis Aurand-Araos

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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.

stockvault-red-and-white-pills126972The research noted particularly, that:

  1. All employees must apply the four key elements of any strategy for building a quality culture. A quality culture requires and ensures that all employees know:
  • Their product or deliverable
  • Their customer
  • Their customer’s quality expectations
  • How to measure that quality
  1. Develop a formal quality policy, common language and leader behaviors as deployment mechanisms.

Start At The Very Root Of Quality Standards and Good Practices

Additionally, in the pharmaceutical industry, FDA regulations set the minimum standards for quality in order to ensure products are safe, pure and effective. These good manufacturing practices are ever evolving with changing technologies, but the roots are established in 21 CFR Parts 210 & 211 (for drugs). FDA has recently began looking at quality metrics as well, and even established an Office of New Drug Quality Assessment (ONDQA) which assesses the critical quality attributes and manufacturing processtockvault-green-plant111329ses of new drugs, establishes quality standards to assure safety and efficacy, and facilitates new drug development.

ONDQA focuses on critical pharmaceutical quality attributes (chemistry, pharmaceutical formulation, stability, manufacturing processes, bioavailability, and product performance) and on their relevance to safety and efficacy. ONDQA emphasizes quality by design in the evaluation of critical aspects of pharmaceutical quality; has a strong focus on manufacturing science; integrates review and inspection functions; and uses modern statistical methodologies. Further to FDA, there are global organizations which establish guidelines for quality as well, such as ISO, ICH, ISPE, WHO, and others.

Use These Four Pillars To Build Your Quality Foundation

WS-12-2013_91Knowing all of the inputs to a quality organization, how does one start to set one up?  The foundation of a solid quality organization is built on four pillars: the quality directive, quality manual, quality policy, and quality objectives. As a primary resource for developing our quality directive, manual, policies, and objectives we look to ICH Q8, Q9, & Q10. ICH Q10 Pharmaceutical Quality System provides for a harmonized pharmaceuticalquality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science in order to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Q10 is a companion document to Q8 – Pharmaceutical Development & Q9 – Quality Risk Management. All three guidances can be used as primary tools for developing your 4 pillars.

Have The Right People, The Right Documentation, and The Right Data To Drive Your Quality Organization

Assuring-Pharmaceutical-Technology-Transfer-Success-eBook Aside from having the pillars in place, the right team makes all the difference. It is important for organizations to invest in their employees through ongoing trainings and certifications. Having subject matter experts in lean six sigma, analytical method development, validation, statistical analysis, change control, root cause analysis, risk management, complaint management, CAPA, etc. within the quality organization is nearly invaluable, and if they are cross-trained all the better. The quality team should work in harmony with operations, balancing risks carefully. The quality leadership team should meet routinely to establish and track/trend quality policies and metrics. These policies and metrics should sync right up to the quality directive, which is driven by management.  Continuing down the hierarchy, after the quality directive, quality manual, and quality policies, and quality objectives, are the organization’s Standard Operating Procedures and Work Instructions. Although it may seem trivial, ensuring that SOPs are aligned with the quality policies is critical. From time to time, an organization may find itself eliminating an entire series of SOPs which are no longer relevant, as policies change. And policies may change as a result of changing regulations or changing corporate strategy.

So, again, ICHQ8, Q8, & Q10 are a great starting point for developing your policies. After that, it flows down to SOPs--developing them and revising them. That's the time where relevant parties weigh in, which is why major SOP changes are brought to a change control review board, to assess risk and impact. The parties affected by the change need to weigh in and evaluate the impact so you're not creating a system now that's going to create a dozen bottlenecks down the road. This is your opportunity to weigh in and make sure the system you're developing can be reactive and agile in the environment. Moreover, the SOPs should always keep the customer first. How will changes affect them? And can we commit without any uncertainty to providing medicines that are safe, pure, and effective.

Lastly, as Lord Kelvin stated, "When you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot measure it, when you cannot express it in numbers, your knowledge is of a meager and unsatisfactory kind. It may be the beginning of knowledge, but you have scarcely, in your thoughts, advanced to the stage of science." Data that is statistically significant and practically important should be tracked and trended and reported back to management as part of the Quality Management Review to ensure accountability, appropriate preventative actions, and a Quality Organization.

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Topics: Quality & Regulatory

Anelis is the Director of Scientific Affairs and Chief Compliance Officer at WellSpring, and has over ten years of pharmaceutical industry experience in Regulatory Affairs, Quality, and Scientific roles. At the University of Florida, Anelis earned her Bachelor of Science in Chemistry, as well as Master of Science in Pharmaceutical Outcomes and Drug Regulatory Affairs. She also earned a Master of Science in Analytical Chemistry at Southern Connecticut State University. In her role at WellSpring Pharmaceutical, Anelis is responsible for the overall corporate quality, compliance, scientific & regulatory affairs direction and strategic guidance for the US and Canadian businesses.

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