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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Put Your Continued Process Verification (CPV) Data To Work
5/22/2020
Though the FDA’s process validation guidance has been in place for over a decade and other regulatory agencies (EMA, WHO, PIC/S) continue to accept the continuous process verification (CPV) concept, adoption has been slowed by the data governance, analytical capability, and technology challenges.
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Cleaning Up The Systems Mess: A Phased Approach To Implementing Real Automation And EBRS
5/20/2020
The biopharma industry uses the most sophisticated microbiological and genomic technology, and we experience waves of advancements in therapies driven by our computing and communications technology. So, why are we still drowning in 100-page paper batch records, books of SOPs on the plant floor, and paper documents being handled by operators?
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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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Should You List All Manufacturing Facilities In Your Drug Application? A Question Of Regulatory Ethics
5/15/2020
In this second installment of a two-part article, we will review the importance of listing all appropriate manufacturing facilities in the drug substance section of a drug application and discuss the role of regulatory professionals in ensuring that the necessary information is included in the application.
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Navigating The FDA’s Emergency Use Authorization Process
5/14/2020
The FDA has been authorized to grant Emergency Use Authorizations for any medical countermeasure that facilitates the diagnosis, prevention, or treatment of SARS-CoV-2. This will impact both internal manufacturing and the CDMOs that drug sponsors employ. Here’s a detailed look at the ramifications and the details.
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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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Introduction To Science- And Risk-Based Cleaning Validation Using ASTM E3106 & E3219
5/6/2020
This article discusses some of the history that began the movement from compliance-based approaches to cleaning validation to the science- and risk-based approaches introduced in the American Society for Testing and Materials (ASTM) E3106 Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation and the ASTM E3219 Standard Guide for Derivation of Health Based Exposure Limits (HBELs).
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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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Should You List All Manufacturing Facilities In Your Drug Substance Application? Understanding The Supply Chain
5/1/2020
In Part 1 of this two-part article, we will review the significance of listing facilities in a drug application — namely, how it connects the dots in the supply chain from a raw material manufacturer to the distributor, manufacturer, packager, wholesaler, pharmacy, and finally, the patient, helping to effectively manage supply chain integrity.