INSIGHTS ON REGULATORY COMPLIANCE
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![GettyImages-614242432-petri-dish-micro-organisms-bacteria]( "Optimal Microbial Sampling Criteria")
Optimal Microbial Sampling CriteriaMicrobiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.
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![Warehouse]( "Reducing Costs & Risks: A Pharma Guide To FTZ Subzones For U.S. Drug Manufacturing")
Reducing Costs & Risks: A Pharma Guide To FTZ Subzones For U.S. Drug ManufacturingUtilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.
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![GettyImages-1227180008 facility design, lab]( "Operational Readiness Frameworks For Pharma And Biotech")
Operational Readiness Frameworks For Pharma And BiotechAchieving top performance in life sciences requires a continuous journey from Operational Readiness (OR) to sustained Operational Excellence (OE), ensuring safe startup and long-term efficiency.
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![GettyImages-139602926 labeling, packaging, pharma]( "The High Requirements Placed On Pharmaceutical Labeling Solutions")
The High Requirements Placed On Pharmaceutical Labeling SolutionsRegulators are implementing new rules to combat counterfeit medicines. Learn how serialization, tamper-evident seals, and track-and-trace solutions protect products and patients from risk.
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Biopharma Supply, Reimagined: Blarney, A Climate-Neutral Facility For Best-In-Class Filters11/11/2025
Explore how a new, climate-neutral manufacturing facility strengthens biopharma supply chains. Understand the benefits of its advanced filtration technologies and commitment to environmental sustainability.
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Remote Regulatory Assessments Q&A2/20/2024
Explore what Remote Regulatory Assessments (RRAs) are and how updated guidance on these examinations could help clarify the consequences of non-compliance.
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PUPSIT As Part Of A Contamination Control Strategy (CCS)8/21/2024
Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.
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Validation And Qualification Approach In New Annex 1 Revision2/21/2025
The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.
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ICH Guidelines: Challenges And Solutions For Pharma Manufacturers10/8/2024
Take the next step in enhancing your pharmaceutical manufacturing processes by investing in a robust quality management system (QMS) designed for ICH compliance and operational excellence.
REGULATORY COMPLIANCE SOLUTIONS
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![Pharmaceutical Container Closure Integrity Testing For IV Bags]( "Pharmaceutical Container Closure Integrity Testing For IV Bags")
The Food and Drug Administration (FDA), United States Pharmacopeia (USP) and EMA Annex 1 issue strict guidelines for testing the integrity of IV bags and containers closed by fusion. IV bag manufacturers are one among many sterile product manufacturers that must meet these test requirements for container closure integrity.
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![Solutions For Injectables]( "Solutions For Injectables And Parenteral Formulations")
Sterility is key for high-risk applications such as injectables, parenteral formulations, ophthalmic and peritoneal dialysis solutions, and many more.
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![DD 1 - GCAPP_Valor size 2 Vial]( "The Future Of Glass Packaging Is Here")
Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.
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![Millipore Express®]( "Millipore Express® Family Guide")
Examine how sterilizing-grade filters with high flux and broad compatibility support efficient bioprocessing across mAbs, vaccines, and viral vectors.
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![GettyImages-2054515915-computer-files-keyboard-digital]( "IDBS PIMS And Regulatory Compliance")
Approach for US FDA 21 CFR Part 11 electronic records and electronic signatures: IDBS PIMS has been designed, developed and tested to enable compliance to 21 CFR Part 11 to accommodate the regulatory needs of its users.
