The lifecycle approach to process validation has become the global standard, incorporated into guidelines by the US FDA, EU, and WHO (See TRS 1019, Annex 3, Appendix 7). Since WHO GMP guidelines apply to Bangladesh, this approach is equally relevant to our pharmaceutical industry. What does this mean for us? Process validation is no longer…
Is a process simulation testing, is a critical validation procedure in aseptic pharmaceutical manufacturing. It ensures the sterility of drug products by simulating the entire production process using sterile media in place of the actual product. The importance of media fill lies in its ability to verify that every step of the aseptic process maintains…
In the pharmaceutical industry, precision and innovation are everything. Among the many technologies shaping this field, the lyophilizer (freeze dryer) stands out as one of the most impactful. Lyophilization Lyophilization or freeze-drying removes water from a product by sublimation converting ice directly into vapor without passing through the liquid phase. It’s performed under low temperatures…
Poly(lactic-co-glycolic acid) (PLGA) is a widely used polymer in drug delivery systems, particularly for creating long-acting injectable microspheres. A crucial factor influencing the drug release profile of these formulations is the glass transition temperature (Tg), which represents the temperature at which PLGA transitions from a hard, glassy state to a softer, rubbery state. Impact of…
ICH Q8 (R2) is a guideline issued by the International Council for Harmonization (ICH) that provides principles for Pharmaceutical Development under the Quality by Design (QbD) approach. The key focus of this guideline is to encourage a systematic, science-based approach to drug development that enhances product quality and process understanding. Objective of Pharmaceutical Development To…
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