For injectable formulations, biowaiver eligibility depends on several factors, including the type of injectable (solution, suspension, emulsion), formulation differences, and regulatory guidelines from agencies like the USFDA, EMA, and WHO. Here are the general biowaiver requirements for injectable projects: Biowaiver for Parenteral (Injectable) Solutions For biowaivers to be granted for injectables, the formulation must meet…
Extended-release injectable formulations are designed to release the active pharmaceutical ingredient (API) at a controlled rate over an extended period, from several hours to weeks. The primary goal of these formulations is to reduce the frequency of administration, minimize drug fluctuations, and maintain therapeutic drug levels, improving patient adherence and clinical efficacy. The development of…
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…
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