Featured Pharma Online Editorial
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Identifying, Documenting, & Auditing Processes For Quality Management
5/25/2020
Process results that are predictable and consistent can be achieved more effectively and efficiently when the activities are considered, managed, and understood as interconnected processes that function as a system.
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Working With Two Consultants On One QMS Overhaul: What Could Go Wrong?
5/18/2020
Some companies in the life sciences mistakenly assume that if they hire multiple consulting firms to establish, manage, or overhaul a quality management system, it will inevitably result in an automatic licensure of their new blockbuster product at a low service cost. This article will discuss just such a scenario.
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Data Integrity In A Cloud-Based World: Regulations & Best Practices
5/11/2020
There was a time when cloud computing was thought of skeptically by the life sciences community, through both the critical observations that are typical of science-based industry and the ingrained cultural resistance to change that comes along with a heavily regulated environment. But today, cloud solutions are ubiquitous in the industry.
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The Missing Links For A Strong Quality Culture: Skill Definition & Assessment
5/4/2020
To build and sustain a strong quality culture, the organization must understand the critical skills needed to assure all employees can act in the patient’s best interest when making decisions on product quality and usability.
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High Absenteeism & The Production Of Medically Necessary Drugs During COVID-19
4/29/2020
A structured approach to problem solving using quality risk management (QRM) techniques can aid in the development and implementation of action plans and knowledge transfer programs to ensure the production of safe and effective drug products in times of staff shortages related to the COVID-19 pandemic.
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Is It Time To Say Goodbye To FMEA Risk Priority Number (RPN) Scores?
4/27/2020
It may be time to consider eliminating the use of the traditional risk priority number (RPN) score and transitioning to the use of action priority (AP) ratings. AP ratings are much simpler to use, do not require a calculation (eliminating the validation of a spreadsheet), and provides a single simple table reference to determine the appropriate level of action.
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Decisions In A COVID-19 World: Combat Stress With Quality Risk Management
4/22/2020
Few of us have ever lived with so much uncertainty and lack of knowledge as we are facing now. This article explains why a structured approach for making risk-based decisions is so important, particularly when we find ourselves in stressful conditions with conflicting needs on many fronts.
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An Introduction To Quality Agreements For Pharmaceutical Outsourcing
4/17/2020
Any time a contractor or CMO is used, including arrangements between different divisions of the same company, regardless of the location of the parties involved, there should be a quality agreement in place.
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Identifying Difficult-To-Clean Surfaces In Manufacturing And Packaging Equipment
4/15/2020
This article describes a practical risk-based approach for assessing and identifying the surfaces, areas, or sites of manufacturing and packaging equipment that are cleaned upon completion of oral solid dosage manufacturing production.
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Harmonious Harmonization: How To Get Quality System Alignment Right
4/8/2020
This article is the second in a two-part series explaining how to successfully harmonize disparate quality systems when two companies combine. Part 1 shared horror stories — drawn from the author’s experiences — illustrating what NOT to do during each phase of QMS harmonization. Here in Part 2, we look at case studies in which companies got it right, bringing together parallel quality systems in a way that increased the probability of success.