- SOP for Operation and Calibration of Analytical Balances
- SOP for Organization of Documents
- SOP for Organization and Handling of Laboratory Chemicals
- SOP for Operation Procedure for Magnetic Stirrer
- SOP for Operation, performance verification of Alliance waters PDA HPLC’s and RI Detector with Millenium-32 Software
- SOP for Operation and Calibration Procedure for Hanson Dissolution Apparatus with Dissoette II
- SOP for Calibration of Volumetric Flasks, Burettes, Bulb Pipettes, Graduated Pipettes and measuring Cylinders and Glass Syringes
- SOP for Operation, performance verfication of Water’s allinace HPLC’s with 2487Dual λ absorbance detector with Millenium-32 Software
- SOP for Operation and Calibration Procedure For Differential Scanning Colorimeter, (Mettler, Tc-15) 32DSC-01
- SOP for Operation of Rotary Shaker (Orbitek : 32ROT-07 )
- SOP for Preparation, Review and Approval of Specifications and Analytical Methods
- Receipt and Reporting of results of FR&D samples and numbering system of Analytical Report Number
- Receipt, Issue and Control of HPLC and GC columns in Analytical R& D
- Allotment of Lot numbers to Volumetric solutions, buffer solutions, test solutions, HPLC mobile phases and Primary Standards
- Cleaning of Dissolution Apparatus
- Operation and Calibration of “Orion pH Meter 420” A+
- Log Book Entries for usage of HPLC
- Operation of Cintex Digital Hot Plate
- Operation, Standardisation and Performance Verification of Karl Fischer Autotitrator Model : 784 KFT TITRINO, and 703Ti Stand unit with TiNet 2.5
- Operation and Calibration of “Metrohm pH Meter 691”
- Qualification of Analysts for Analytical Techniques
- Preparation Of Standard Buffer Solutions For Calibration Of pH Meter
- Operation and Calibration procedure for GC system and Head Space (HP 6890 & HP 7694) (32GCH-01)
- Operation and Calibration Procedure for Sonicator
- Establishing alternative equivalent HPLC Column
- Operation and calibration of Remi Centrifuge
- Operation And Calibration Of Essae Balance (6.0 Kg Balance)
- Operation and calibration of Spinwin Micro Centrifuge
- Operating And Calibration Procedure For VK7000 Dissolution Apparatus With VK8000 Auto Sampler (32DIS-03)
- Operation and Calibration Procedure for Centrifuge Make: Hermle Z 323
- Operation and calibration of Lab India dissolution tester Model DISSO-2000 with sample collector model SC-2000
- Numbering of Registers and Files
- Operation of Milli-Q Gradient water purification system with Elix 10
- Operation and Calibration of HR-83P Halogen Moisture Analyzer (Mettler Toledo)
- Operating and Calibration procedure for Analytical Balance (Mettler AG245 & 285)
- Preparation of HPLC Mobile Phase
- Operating Procedure For Cyclo-Mixer ( Make : Remi)
- Operation and Calibration of Pharmatest Hardness Tester (32HAR-03)
- Documentation and reporting of results of Analytical method validation
- Operating and calibration procedure for HPLC system (32HPL-06)
- Operation and calibration of Melting point appratus, Model FP 90
- Operation and Calibration of Analytical Balances
- Bracketing Standards during Content Uniformity, Assay, Dissolution, Related Substances and residual solvents by GC
Analytical Research & Development (Analytical R&D) in pharma is the function that develops, validates, and transfers test methods needed to characterize materials and ensure drug products meet quality requirements throughout development and commercialization. It bridges discovery, formulation/process development, manufacturing, QC, and regulatory submissions.
A core responsibility is method development for APIs, intermediates, excipients (where needed), and finished products. This includes building stability-indicating assays (typically HPLC/UPLC), impurity profiling, residual solvents (GC), dissolution, particle size, polymorphism (XRPD), moisture (KF), elemental impurities (ICP-MS), and microbiology/bioburden tests where applicable. Analytical R&D also establishes specifications aligned to ICH expectations (identity, assay, impurities, dissolution, microbial limits) and supports reference standard/working standard qualification.
Another major role is method validation and verification. Analytical R&D validates methods per ICH principles (accuracy, precision, specificity, linearity, range, robustness, detection/quantitation limits) and ensures data integrity (ALCOA+). For compendial methods, they perform method verification/suitability for the specific product and lab environment. During development, methods are continually optimized to improve robustness and reduce variability before transfer to QC.
Analytical R&D drives stability programs: protocol design, storage condition selection (ICH zones), time-point testing, trend evaluation, and investigation of atypical results. Stability data supports shelf-life assignment, packaging selection, and change assessments. They also support process development by evaluating critical quality attributes (CQAs), impurity generation pathways, cleaning verification, extractables/leachables (packaging), and comparability studies during scale-up or site transfers.
Finally, Analytical R&D is key for technology transfer. They prepare transfer protocols, train QC analysts, define system suitability and acceptance criteria, troubleshoot OOS/OOT issues post-transfer, and ensure lifecycle management through change control and periodic review. In short, Analytical R&D provides the scientific measurement backbone that proves product quality to regulators and patients.