Month: October 2023

Cost-Effectiveness and Operational Efficiency in Pharmaceutical Packaging

Cost-Effectiveness and Operational Efficiency in Pharmaceutical Packaging

Achieve cost-effectiveness and operational efficiency in pharmaceutical packaging with optimized processes and streamlined operations. Optimize packaging materials and strategies to reduce costs without compromising quality or safety. Enhance efficiency through advanced automation technologies and inventory management systems.   Optimizing Packaging Processes Streamlining the packaging processes is crucial for pharmaceutical companies to ensure cost-effectiveness and operational…

Pre-Requisites for Analytical Method Validation

Pre-Requisites for Analytical Method Validation

Prerequisites is usually a checklist which is sent to the Receiving Laboratory which in most of the cases is the Quality control laboratory of the manufacturing.   This checklist is prepared by the Department or the team which is involved in the method validation/verification/transfer activity and contains all the things which are required and needed…

Advanced Materials And Technologies in Pharmaceutical Packaging

Advanced Materials And Technologies in Pharmaceutical Packaging

  Advanced materials and technologies play a crucial role in the field of pharmaceutical packaging. These innovative solutions enhance the safety, security, and efficiency of medication delivery, ensuring optimal patient care.   Smart And Intelligent Packaging Integration of sensors and electronic devices in packaging to monitor various factors like temperature, moisture, and light exposure.  …

10 Useful Tips for Temperature Mapping of Storage Area
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10 Useful Tips for Temperature Mapping of Storage Area

1. Start by identifying the areas in the storage facility that need to be temperature mapped. This could include refrigerators, freezers, cold rooms, or any other specific areas where temperature control is critical.   2. Determine the appropriate temperature range for each area based on the specific requirements of the stored items. This could vary…

The Significance of Excipients in Injectable Drugs | A Hidden Concern

The Significance of Excipients in Injectable Drugs | A Hidden Concern

When it comes to pharmaceuticals, the focus often centers on the active ingredients that bring relief and healing. However, the less-discussed but equally important components in drugs are known as excipients. Excipients are essential for various reasons, including drug stability, bioavailability, and even patient safety. In the realm of injectable medications, the role of excipients…

Measurement of Discriminatory Power of Dissolution Method

Measurement of Discriminatory Power of Dissolution Method

One major criterion for selecting the QC dissolution method should be its discriminatory power to show changes in the critical attributes of the release mechanism of the chosen formulation.   The discriminatory power is the ability of a test procedure to discriminate between batches manufactured with different critical process parameters and /or critical material attributes…

FDA Warning Letter on cGMP Violations of US Based Compounding Facility
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FDA Warning Letter on cGMP Violations of US Based Compounding Facility

A Waring Letter (#659142) issued to a US based compounding facility for several serious cGMP violations, including:   Several other violations were listed for non-HEPA filtered air, lack of validation of aseptic processes, inadequate cleaning and disinfection, issues with facility design, inadequate environmental monitoring, lack of final product testing and an inadequate stability program.  …