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PDA revises report on glass container manufacturing

European Pharmaceutical Review

43: Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing. Specifically, the document covers the development process of glass containers for pharmaceutical products, glass container sampling as well as definition of lots.

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Navigating 340B Program Changes in 2025

Proxsys Rx

billion in 340B savings is at risk, due to increasing limitations imposed by pharmaceutical manufacturers which could further strain the healthcare safety net and patient care services. Then the manufacturer will approve a rebate and send money back to the CE for the difference in 340B and retail price. Additionally, up to $8.4

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Deviation investigation guidelines in the pharmaceutical industry

GMPSOP

Additional documents included each month. Additional documents included each month. Subscribe Different types of deviations in pharmaceuticals There are two types of deviations. If the complaints are persistent, they may reflect a fault in the manufacturing process or formulation. Additional documents included each month.

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How to use quality risk management in validation testing

GMPSOP

Table of Contents Quality risk management principles are already effectively utilized in many areas of pharmaceuticals manufacturing business. Additional documents included each month. Risk management scope definition The purpose or objective of the application of risk management needs to be clearly understood.

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Corrective and Preventive Action (CAPA) Procedure for GMP

GMPSOP

By definition, corrective actions are required to eliminate the causes of an existing nonconformity, defect, or other undesirable situation. Additional documents included each month. Additional documents included each month. Corrective actions are taken to fix a defect on hand. All written and updated by GMP experts.

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NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics

Putting Patients First Blog

12 To this end, the NHC encourages the FDA to establish clear expectations for how sponsors validate and document AI-driven findings that are submitted as part of the regulatory dossier. Finally, to support transparency, reproducibility, and traceability, the FDA should require thorough documentation of AI model validation and verification.

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How to test, adjust and balance HVAC systems

GMPSOP

Additional documents included each month. Subscribe Some useful definitions of HVAC systems maintenance HVAC: Heating, ventilation and air conditioning is the use of various technologies to control the temperature, humidity and purity of the air in an enclosed space. Additional documents included each month.