Featured Pharma Online Editorial
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A Practical Guide To Navigate The EU's Revised GMP Annex 1
9/9/2022
The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is new and different, how to document your "known unknowns," and more. Quality risk management and a contamination control strategy will be key.
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How To Avoid Form 483s For Biopharma Software Validation Failures
8/17/2022
The FDA will issue a Form 483 for noncompliance in the software validation GxP environment, mostly due to data integrity failures, inadequate written procedures, deficiencies in investigations, and substandard laboratory controls.
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Tools & Techniques For Biopharma Root Cause Analysis
8/10/2022
In biopharma, we must provide a complete and thorough record of our thought processes in order to allow a third party to understand how we have arrived at the root cause of a given problem. This article follows a mock case study to demonstrate a progression of tools and techniques to use.
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CAPA System Best Practices For GMP Compliance
7/25/2022
A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. This article delves into the pros and cons of autonomous and integrated systems, and shares some overall CAPA best practices.
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FDA Seeks Comment On ICH Q9(R1) Quality Risk Management
7/5/2022
ICH has revised Q9 Quality Risk Management, providing principles and tools that can be applied throughout the product life cycle of drug substances, drug products, biological, and biotech products. The FDA, a founding member of the ICH, plays a major role in the development of ICH guidelines, which FDA then adopts and issues as guidance to industry.
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FDA Updates Guidance For Investigating OOS Test Results
6/24/2022
FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.
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FDA Proposes Benefit-Risk Considerations For Product Quality Assessments
6/20/2022
The FDA recently released for public comment Benefit-Risk Considerations for Product Quality Assessments: Guidance for Industry. Mark Durivage breaks down the guidance and how the FDA considers and assesses risks, sources of uncertainty, and possible mitigation strategies for product quality-related issues and how unresolved product quality issues may be addressed.
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FDA Finds Drug Shortages Are Mostly Caused By Quality Issues
6/6/2022
New FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages recommends an RMP for drugs that treat rare diseases and conditions, drugs with no alternatives, sole source products, products with only one API or manufacturing site available, and drugs made in facilities where an Official Action Indicated has been issued.
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The Growing Value of Quality & Compliance Professionals in Decentralized Pharma
5/25/2022
The phrase “the pharma ecosystem” has begun to pop up. Who is best suited to envision, support, and strategize a quality management vision in our current “ecosystem”? Here are some reasons your company and employees should value the unique skillset of these individuals more than ever.
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3 Keys To A Fit-For-Purpose Compliance Strategy In Decentralized Pharma
4/25/2022
Outsourcing and technology have morphed our industry into a new decentralized model. Now, each sponsor must carefully develop an ongoing compliance strategy considering its unique business model and its influence on the drug development journey. Strategies are needed to design QMS' that can expand and pivot in tandem with corporate and clinical development.