The ADL role focuses on analytical method development, validation, and routine testing for finished products and APIs.
Key responsibilities include:
- Analytical method development for various dosage forms and APIs:
- Method validation, verification, and transfer with complete documentation:
- Routine analysis using HPLC, UV spectrophotometer, and dissolution apparatus:
- Assay, dissolution, content uniformity, blend uniformity, and related substances testing:
- Preparation of protocols, validation reports, and analytical documentation:
- Independent handling of regulated analytical activities