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Critical Processing Parameters in the Fabrication of PLGA Microparticles
Introduction Poly(lactic-co-glycolic) acid (PLGA) microparticles have gained significant attention as controlled drug delivery systems. Despite their potential, the translation of these systems from research to FDA-approved products remains limited. A major challenge lies in understanding the critical processing parameters (CPPs) that influence their fabrication and scale-up. A recent study by ... Read More
Critical Material Attributes (CMAs) of Excipients
When focusing solely CMAs of excipients, the same principles of API apply. These attributes influence the performance and manufacturability of the final drug product and are critical for achieving consistency in pharmaceutical formulations. Critical Material Attributes of Excipients Physical Properties Particle Size Distribution (PSD): Bulk Density and Tap Density: Specific ... Read More
Alcohol Dose Dumping | A Critical Pharmaceutical Challenge
Introduction Alcohol dose dumping occurs when controlled-release formulations release their active ingredient rapidly in the presence of alcohol. This unintended release can lead to elevated drug levels, increasing risks of toxicity, side effects, or overdose. Mechanisms of Alcohol Dose Dumping Drugs at Risk Clinical Implications Preventive Measures Patient Strategies Regulatory ... Read More
CAS (Chemical Abstracts Service)
What is the CAS chemical number? A CAS Registry Number is a unique and unambiguous identifier for a specific substance that allows clear communication and, with the help of CAS scientists, links together all available data and research about that substance. Purpose of CAS Number 01) Uniqueness CAS numbers are ... Read More
VagiSense | A Non-Prescription Vaginal Infection Screening Test
According to a study, about 66% of women who self-diagnosed a vaginal yeast infection were wrong. VagiSense® is a non-prescription home vaginal infection screening test that helps identify if vaginal symptoms are more likely caused by a bacterial or parasitic infection to know what steps to take next. It’s a ... Read More
SOP for Change Control in Pharmaceutical Industry
1.0 OBJECTIVE To lay down a procedure for Change Control. 2.0 SCOPE The SOP is applicable to any change in the documentation and facility required to be carried out to make amendments, rectify errors, improvements, meet regulatory/ statutory/ legal requirements. It shall be applicable to all Departments at XYZ pharm. ... Read More
Quality Plan for a Product or Service Realization
The product and service provision planning process defines the following controls, as appropriate to the product. This plan is sometimes called a quality plan. The quality objectives and regulations The necessary processes, documents and resources The required checks and criteria for product acceptance The records needed Planning also leads into ... Read More
Foundational Principles of ICH GCP
Let’s delve into the fundamental principles that shape the ethical conduct of clinical trials according to ICH Good Clinical Practice (GCP): Ethical Foundation: Clinical trials must align with the ethical principles outlined in the Declaration of Helsinki, ensuring consistency with GCP and relevant regulatory requirements. Balancing Risks and Benefits: Before ... Read More
The Power of Effective Change Control Programs in Pharma Industry
In the fast-evolving landscape of the life sciences industry, the ability to manage change effectively isn’t just beneficial; it’s essential. Change control programs are at the heart of this, ensuring that any changes in processes, equipment, or materials are implemented in a controlled and systematic manner. Why is this important? ... Read More
Key Steps in Uncertainty Determination Based on Empirical and Modeling GUM Approaches
Identify the sources of uncertainty: The first step is to identify and understand the different sources of uncertainty in the measurement process. This can include variability in the measurement instrument, environmental conditions, operator skill, and other factors. Quantify the uncertainty from each source: Once the sources of uncertainty are identified, ... Read More