Featured Pharma Online Editorial
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4 Focus Areas To Modernize Your Cleaning Validation Strategy
1/30/2023
The traditional outlook on cleaning validation might look inexpensive and safe, but it can lead to serious problems in the long run. To modernize your cleaning validation strategy for 2023, here are four areas to focus on.
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What's Behind The ASTM E3263 Standard Revision?
1/17/2023
ASTM has published the revision of ASTM E3263 Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues. This article, written by the ASTM revision team, explains the reasons behind the revision and delves into the key updates.
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FDA Adopts ICH Final Guidance On Bioanalytical Method Validation
1/11/2023
The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.
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CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance
12/21/2022
While the concept of contamination control is not new, the EU's revised GMP Annex 1 requires a formally documented strategy specific to a facility. Under the new set of requirements, the “span of oversight” has shifted, and CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency with sponsors.
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5 Steps To Eliminate Weak Links In Your Data Governance
12/2/2022
Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.
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Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
12/1/2022
This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.
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FDA Releases Guidance On Drug Products Containing Nanomaterials
11/18/2022
In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.
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Key Insights From The 2022 PDA/FDA Joint Regulatory Conference
11/3/2022
Key focus of this article is spent on thoughts shared by the FDA speakers, including the importance of a quality infrastructure, sustainable compliance, data integrity, and more.
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Pharma 4.0 Software Methodologies In Biopharma And Medical Devices
10/10/2022
The life sciences industry has been using computer software testing methodology to validate software that is categorized to be GxP in alignment with the principles of good automated manufacturing practices and Industry 4.0 standards. This article discusses the methodologies of computerized system validation, computer software assurance, and the Agile approach.
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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.