Featured Pharma Online Editorial
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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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The Environmental Impact Of Biopharma Continuous Manufacturing
8/8/2022
One aspect of biopharma continuous manufacturing (BCM) often overlooked is its environmental impact compared to that of a similar batch process. In comparing the two, there is much that needs to be considered. This article is the first in a two-article series and discusses key considerations of both processes and provides a deep-dive into water usage.
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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 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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Assessing Extractables & Leachables In Parenteral Drug Products
6/8/2022
Therapeutic complexity increases the potential risks associated with chemical composition of materials used for drug packaging. Leachables in drug or biological products are chemical compounds that originate from components that are used to store and deliver medicines. Extractables should be considered as potential leachables.
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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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AstraZeneca Implements A "Technology Uplift" Of Its Microbiology Labs
5/31/2022
Modern microbiology labs are busy, with a wide range of activities taking place from final product testing to auxiliary support such as quality control release checks on nutrient media. While instruments and equipment available to technicians can vary, AstraZeneca wanted a networkwide approach to modernizing its labs.
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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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Calculating Process Capability Of Cleaning Processes With Partially Censored Data
5/19/2022
When cleaning sample results are below the detection limits (DLs) of an analytical method, these data are known as "non-detects" or "left-censored" data. There are basically two broad classes of methods that are applied to left-censored data: Substitution and Estimation. This article explores these methods for use with cleaning sample data when some of the points are below the DL.
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Pharmaceutical Quality Compliance In 2022: Data Is Paramount
2/11/2022
Pharma quality and compliance leaders must anticipate potential manufacturing issues before they happen by leveraging risk-based methodologies, continuously monitoring their systems, and tracking the profusion of data generated during the process. This article outlines the potential of data and analytics to improve quality performance.