Critical Environments Columns
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EMA's Revised GMP Annex 1 Addresses Common Global Challenges For Sterile Products
1/18/2023
The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.
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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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Cleanroom Gowning Programs Compliant With EU GMP Annex 1
12/15/2022
Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.
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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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Calculating Process Capability Of Cleaning Processes With Completely Censored Data
10/31/2022
Data below the detection limit (DL) are known as left-censored data. Quite often, 100% of the results of the cleaning samples fall below the DL. How can cleaning process capability be calculated in such situations? This article explores several approaches.
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Pharma Process Validation: Initial Conclusions Are Often Deceptive
9/26/2022
As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.
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Biopharma Facility Modular Design & Construction: Key Considerations
9/12/2022
In facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain standardized modules and components reach, the wider the benefits.
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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.