FDA Guidelines
Particle determination for drugs
FDA Guidelines - references for particle analysis
The US Food and Drug Administration (FDA) provides specific recommendations and requirements for particle determination, to ensure the quality and safety of drugs.
For particle analysis, the guidelines for Visible Particles, Subvisible Particles and Analytical Tecniques are particularly relevant, and is further described below.
Guideline for Visible and Subvisible Particles
Visible particles
The FDA guidelines emphasize the importance of visually inspecting drug products for the presence of visible particles. Manufacturers are advised to develop appropriate inspection procedures and controls to detect and remove visible particles. The guidelines provide specifications regarding the size and type of particles that should be considered objectionable.Subvisible particles
In addition to visible particles, subvisible particles play a significant role in drug safety evaluation. FDA guidances provide recommendations on the measurement and control of subvisible particles, particularly those that may impact product quality or pose a risk to patient safety.
Guideline for Analytical Techniques
FDA guidelines include guidance on specific analytical techniques that can be implemented to determine particle levels in drug products.
These techniques may include microscopy, light obscuration, flow imaging analysis, or other validated methods.
Manufacturers are encouraged to establish appropriate analytical methods and acceptance criteria for particle determination, ensuring robust control measures are in place.
Commitment to quality and compliance
Particle determination is a crucial aspect of drug development and manufacturing, as the presence of any particulate matter in pharmaceutical products can have serious consequences for patient safety and product efficacy.
As a FDA approved contract laboratory, our team of experts stays up-to-date with the latest FDA requirements and industry best practices, to provide you with the highest quality particle analysis services.
Partner with us to ensure your pharmaceutical products are safe, effective, and of the highest quality. Get a quote or contact us to explore how we can help you.
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