Mahesh Inamke

Planning of Analytical Drug Product Developments per QBD (Analytical Method Development and Compatibility Studies), Specifications, Impurity Profiling, Analytical Method Validations [(Assay, Related Substances, Residual Solvents, Dissolutions (immediate and extended release)], Stability Support to R&D batches. Method Transfer and Technical Support to Quality Control. API & Excipient Test Verifications. Support to Quality Control for Submission Batches NDA & ANDA Submission documentation and CMC Deficiency Response Support to Regulatory. Responsibility for CMC section of the drug product in developing regulatory assessments and strategies in support of new product initiatives and product lines for NDA, ANDA, and ANADA's. preparation of PDR sections of the Drug Product. Leading the analytical R&D team (developing, training and mentoring). Managing CMO's/CRO's for projects. Planning budget and resources for laboratory/projects including annual instrumentation maintenance and calibration contracts (creating work orders, service agreements and confidential agreements). Preparation of protocols and reports for the qualification of new instruments with establishing the laboratory SOP's.

CMC Deficiency Response Support to Regulatory. Responsibility for CMC section of the drug product in developing regulatory assessments and strategies in support of new product initiatives for ANDA. Preparation of PDR sections of the Drug Product. Development and Validation of Analytical Methods, Prepare SOP's, STP's and conduct OOT's & OOS investigations. Provide technical assistance to Quality Control and Regulatory. Supporting ongoing routine and In-process Product development formulation samples throughout their developmental to the final stages as per QBD requirements.

Development and Validation of Analytical Methods, Prepare SOP's, STP's and conduct OOT's & OOS investigations. Technical assistance to Quality Control and Regulatory. Supporting ongoing routine and In-process Product development formulation samples throughout their developmental to the final stages as per QBD requirements.

Lead the team for planning and execution of analytical method
development and validation activity.

Development of solubility studies and In-vitro dissolution
methods to evaluate the comparative dissolution profiles.
Evaluate the QBD strategies and DOE strategies to assess the
future risk assessments of product.
Support the plant team for the root cause findings to OOS and
OOT.
Conduct the stability studied for the formulation development
and provide the compilations to formulation development for
further formulation development.
Risk assessment evaluations based on current regulatory
requirements like nitrosamine impurity estimations.
Communication with the CFT's for development strategies.
Ensure the cGMP and strict GDP practices in the laboratory to
achieve compliance in workplace.
Training to the juniors for development and documentation
practices
Responses to the CRL OR IR received from the regulatory
agencies.

Preparing, executing, monitoring and presenting analytical method development strategy of the projects handled.
Communicating status, progress, and challenges during analytical method development, internally and externally in written and verbal formats.
Planning and execution of analytical activities and Review of routine and stability data.
To co-ordinate within the groups for method development, troubleshooting related to new as well as exiting products and validation of analytical methods.
Planning and execution of analytical instruments calibration and Review of the same.

Analytical method development and validation.
Preformulation studies, solubility studies as per BCS guidelines and Forced degradation studies, cleaning method validation for Finished Product.
Analysis of routine samples and stability samples.
Calibration of analytical instruments.
Handled HPLC, UPLC, IC, IR, UV. VISI Spectrophotometer, Dissolution Tester (Type I, II, IV, VII), Malvern Particle size Analyser, KF titrator, Disintegration test Apparatus, Hardness Tester, Viscometer, pH meter, Particulate Matter Etc.

Isolation and characterization of impurities

Development and Validation of analytical methods (assay, impurities and residual solvents etc., ) for testing API and Finished Products using Analytical Techniques

Performing chemical analysis, dissolution studies, and Assay and Related substances of routine samples.
Daily lab monitoring including calibration of the pH meter and analytical balance.
Assisted in the method development.