best practices organizations should be aware of when conducting .... Raland Compliance Partners will be hosting a. Works
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Design, Quality, Compliance, Manufacturing: Establishing the Right Checks and Balances to Protect Your Business Q&A eBook with Raland Compliance Partners
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Is your Organization ready for a fresh start? “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” -origin unknown
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1. How can organizations meet FDA expectations, while staying competitive in such a fastpaced, demanding market?
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1. The FDA expects Industry to be compliant to regulation and effective in the control over the production and provision of high quality products that our customers and patients expect. Meeting FDA expectations can be achieved by improving your Quality System and transforming it into a system that ensures quality, by design. Quality by Design (QbD), as a concept, simply means that you have planned for, and developed the understanding of the Critical Quality Attributes (CQA) of the product and the necessary controls over Critical to Quality (CtQ) production processes. A QbD approach can also be used retrospectively to address product currently in the market for improved control and assurance that ongoing quality requirements will be met.
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2. Why do so many organizations take a reactive approach when problems arise?
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2. Once systemic control is lost, people become reactive by nature. Improved systematic behavior is enabled by acting now, in advance of another future situation, to develop an anticipatory understanding of: Product attributes that are critical (CQA), their boundaries and how to control them; Production process parameters necessary to control critical product attributes; Quality System processes used to manage production quality and emerging issues. A proactive approach for control is now enabled as a result through Quality by Design (QbD). QbD principles can be utilized during the corrective actions process to address the problem, improve control, and assure quality requirements are met going forward.
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3. How do organizations create a proactive culture of operational excellence?
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3. A proactive culture is enabled through the utilization of Quality by Design (QbD) concepts. A proactive culture is enabled through the utilization of Quality by Design (QbD) concepts. Define: develop an anticipatory understanding of: Product attributes that are critical quality attributes (CQA); Production process parameters that significantly impact CQAs, known as critical process parameters (CPP); Quality System controls over what is Critical to Quality (CtQ) to: manage quality and emerging issues; obtain effective results from each QS process
Execute the work, as planned Measure the results of the execution of the work to identify issues and constraints Improve the system by fixing the issues and improving the processes that constrain the system
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4. What are best practices organizations should be aware of when conducting an end to end analysis of a business?
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4. Patients first! Focus on control. It is imperative that we are highly effective in the control over the production and provision of high quality products that our customers and patients expect. Compliance ≠ quality A Quality System that is fully compliant to regulations may not actually be effective in obtaining the necessary results, nor efficient in operational execution. Organizations must strive to be compliant, effective and efficient!
Compliant, Effective, Efficient A thorough analysis includes an assessment of the compliance, effectiveness and operational efficiency of each process within the Quality System to provide proper assurance that the Quality System is capable of the ensuring the ongoing provision of high quality products.
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5. What are some misconceptions surrounding QbD strategies?
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5. QbD is new. Quality by Design (QbD) is relatively new to the Life Sciences industry, however, is not new to other industries since being first introduced the 1950s in the chemical industry. QbD is only applicable for use in Pharmaceutical and Biotech companies. QbD, is simply a concept, and is not at all limited in any aspect or application. Establishing quality “by design” is fundamentally about reducing risk by designing quality into the product and the associated production processes, inclusive of the control mechanisms. Simple.
QbD is can only be used during the development of new products. QbD can be applied at any time during the product lifecycle. Continual improvement opportunities to improve the safety and effectiveness of the products our patients and customers use should always be a business focus.
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6. In your experience, when companies have developed strong QBD strategies, what has the outcome been like?
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6. Some of the many advantages include: Improved control over high risk product failure modes resulting in an organizational focus on the safety and effectiveness of the marketed product Improved customer satisfaction Improved regulatory stakeholder satisfaction Improved business stakeholder satisfaction Greater control means decreased costly field corrective action activity that significantly damages the business Improved constraint management and identification of continual improvement opportunities Strong culture of accountability resultant from an understanding of the production controls and utilization of the Quality System for control
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Your Sustainable Compliance and Remediation Partner Conduct an end to end analysis of your businesses exposure to risk to establish key steps on what to do next Product Quality What is the quality of currently marketed product? Is there patient harm associated with the product? How strong are the production controls that are associated with high harm failure modes?
Quality System Are the processes within each QS subsystem properly defined such that they are compliant to regulation and applicable standards? compliance ≠ quality Are the processes within each QS subsystem measured and found to be: Compliant in terms of adherence in execution of the system; Effectively executed in obtaining results; Efficient in operational execution? Are the Quality System issues and constraints continually improved?
Futureproof the business through understanding new announcements by the FDA along with a focus on what's to come The FDA and the Life Sciences Industry are aligned in our intent of providing high quality products for our customers and patients. We approach this “charter” through a regulatory scheme that is both complex and subjective, which can easily yield a violation of regulation resulting in compliance enforcement risks. Guidance documents represent FDA's current thinking on a topic and describe FDA’s interpretation of their policy on a regulatory issue (21 CFR 10.115(b). The stated purpose of FDA guidance is to “improve the consistency and transparency” of their thinking and actions. Still, being studied in regulation and guidance is not enough. The stakes for our patients and customers are too high. Industry must work in partnership with the FDA, and take ownership of the quality of our products. Compliance and quality are not the same. To futureproof our business from risk, we must utilize Case for Quality and Quality by Design concepts, for a compliant, effective and efficient future!
Empower your people. Take steps to create a culture of accountability and learning that allows them to be proactive versus reactive A proactive culture of accountability is enabled when the system they work within is well defined, enabling understanding and operational control.
Define the work such that people can: manage quality and emerging issues; obtain effective results from each QS process
Execute the work, as planned Measure the results of the execution of the work to identify issues and constraints Improve the system by fixing the issues and improving the processes that constrain the system In an environment such as this people become empowered. Constraints are identified, investigated and understood. Ongoing continual improvement becomes the standard mode of operation. Managers focus on control. Management can focus on strategic growth.
Establish QBD strategies that drive strong compliance efforts across the business Product QbD Achieved through scientific methodology and the utilization of statistical tools to establish the mathematical relationship between the input variables of the product and critical quality attributes (CQA) of the product.
Production processes QbD Achieved through an understanding of the capability of the critical production parameters (CPP) affecting the critical quality attributes (CQA) of the product. These are associated with critical to quality (CtQ) processes that must have active control(s) around the CPPs and continual monitoring of output results for both common cause variation and special cause variation. This approach is valid for the manufacturing control of pharmaceutical products as well as medical device products.
Quality Systems QbD Achieved by ensuring the QS processes have been well designed to allow the people who manage those processes to proactively measure, monitor and manage emerging issues. This enables small issues to be proactively managed so they do not develop into large issues that are difficult to control. Once control is lost, trouble starts.
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Raland Compliance Partners Your sustainable compliance and remediation partners We provide compliance consultation and guidance for organizations in the pharmaceutical, biotech and medical device industries. In all GxP engagements, we strive for immediate and sustained process improvement, from product development to patient delivery. Raland Compliance Partners will be hosting a Workshop on "Design, Quality, Compliance, Manufacturing: Establishing the Right Checks and Balances to Protect Your Business" at Generis' American Medical Device Summit 2017. Join us to learn more and participate in this workshop session!
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