The Overall Analysis: Pharmaceutical Validation
DOI:
https://doi.org/10.62896/ijpdd.2.5.06Keywords:
Good Manufacturing Practices, pharmaceutical validation, compliance, design, analytical techniques, and quality.Abstract
Validation in the pharmaceutical domain confirms the effectiveness, safety, and quality of the product, hence it is a crucial phase along the medication's development and production path. This step entails confirming that the production processes, devices, and techniques of analysis are compliant with the laws and regulations established by the FDA and EMA. Ranging from accuracy to repeatability, reliable validation criteria assure efficiency in drug performance. For the pharmaceutical industry, stringent compliance assurance pertaining to validation procedures serves as guidelines through Good Manufacturing Practices (GMP). The adoption of digital and automation technologies has improved validation methods, making them easier and more reliable to implement. Validation processes must always be enhanced considering the continuously shifting regulations, economic constraints, and increasing complex technologies. By employing risk-based approaches and applying new techniques like Process Analytical Technology and design concepts such as Quality by Design (QbD).
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