Eligibility: Professionals from Analytical Development/ QC/ QA/RA/ any relevant department
Duration: 2 months [Sunday batches, 5 hours per Sunday]
Course background: Appropriate analytical data review is a key requirement of Pharma industry. Warning letters, inspection observations talks majorly on gaps seen in internal review. Keeping this in mind, IPM is introducing a specialized course on ‘Analytical Data Review’ based on current regulatory guidelines.
Features:
- Discussion on actual analytical data of API & Formulation
- Various analytical tests- calculations and reporting results
- Review raw data, HPLC/GC Chromatograms, excel sheets, COAs, protocols, reports
Contents:
Section 1: QC: Responsibilities, Work flow, Pharmacopoeia, monographs
Section 2: Instrumentation techniques and use:
HPLC, GC, IR, UV, AAS,
Dissolution
Tests, methodology, raw data reading, Interpretation, calculations & reporting
Review of :
Section 3: Analytical method validation & forced degradation study
- FDS /AMV protocol, report
- Linking of Solution stability and Robustness to test method
- Common deficiencies
Section 4: Specification and COAs – RM, Excipients, APIs, PM, FP
- Importance, Setting of tests, limits
- Batch analysis & analytical exhibits
Section 5: Reference Standards and Working standards
Section 6: OOS, Incidences & Data Integrity
Section 6: Stability data
- Regulatory requirements of various countries
- Protocol verses data, Stability specification
- Acceptable data, unacceptable data
Section 7: Characterization
- Techniques used- IR, UV, Elemental analysis & MS, reading & interpretation
- Polymorphism by XRD, IR & DSC – reading , interpretation and conclusion