Analytical method development and validation are critical for the discovery, development, and manufacture of pharmaceutical products. The process involves creation and optimization of analytical methods to accurately and consistently measure the concentration of an active pharmaceutical ingredient (API) in a compounded dosage form. It helps in checking the drug purity, quality, and safety during the development and manufacturing process.
The analytical methods used in pharmaceuticals must meet specific regulatory requirements and guidelines, including that of:
- FDA’s Good Manufacturing Practices (GMP)
- International Conference on Harmonisation (ICH)
Validation of analytical methods ensures that the drug is accurate, reliable, and consistent in their performance. It involves rigorous testing to establish the suitability of the method for its intended use.
PLS Analytical is a premier institution dedicated to upholding the highest standards in analytical testing.
We use our state-of-the-art cGMP laboratories and equipment to conduct systemic qualitative procedures involving chemical and microbiology testing for pharmaceuticals, biopharmaceuticals, environmental monitoring organizations, and packaging component companies. Our services are data-driven and results-oriented with absolute compliance with FDA regulations.
BENEFITS OF ANALYTICAL METHOD DEVELOPMENT
Method development is a crucial part of analytical testing for pharma products because it;
Attests to the accuracy of analytical data as it is essential to ensure the quality and safety of pharmaceutical products.
Facilitates regulatory compliance by ensuring all analytical methods meet the necessary standards and guidelines.
Improves efficiency through optimization of analytical procedures, reducing both time and costs associated with testing and analysis.
Supports R&D through reliable methods to analyze new compounds and formulations.
Enhances the brand’s reputation by proving its commitment to quality and excellence in pharmaceutical manufacturing.
At PLS Analytical, we study and understand the specific objectives of our clients and offer appropriate solutions, not as a service provider, but as a partner in their endeavor.