We have a qualified person (QP) & Pharmaceutical Consultantfor conducting of External Audits to fulfill the compliance of all regulatory bodies.Dr. Reddy till now 40(Mylan, Aurobindo, Hetero, Suven, MSN etc…) audits were completed.Dr. Reddy completed M. Pharmacy (Pharmaceutical Chemistry) and Ph.D in Pharmaceutical Analysis. He has 35 International and National research papers having Cumulative Impact factor 15.0. Dr. Reddy having good knowledge on ISPE, USFDA, Eudralex, PIC/S, ICH and WHO requirements and regulations.
A. MAJOR EXPOSURE:
1. API and Formulation CGMP, Vendor & Facility Audits as per USFDA, EU GMP, WHO,TGA, Health Canadaand PIC/s requirements.
2. BA and/or BE Studies (RLD vs Test Crossover and Parallel) Auditing as per USFDA, EU and PIC/S requirements
3. Contract Manufacturing and Contract testing laboratories Qualification audits as per current regulatory requirements
4. Validation and Statistical Expert as per ISPE,USFDA,EU,PIC/S and WHO requirements
5. QbD (Single factorial and Multi factorial) Product development reviews as per regulatory requirements.
6. Quality Risk management studies for any stages
7. Computerized system validations as per GAMP5, Eudralex and 21 CFR Part 11.
8. Continued Process verification and Statistical process control(Six sigma, Control charts etc…)
9. ANDA Filing as per US and EU(Centralized, Decentralized ,Mutual and National procedures)
10. R&D Laboratory for DQA establishment of management system procedures
11. Process Validation(all stages justifications and statistical process controls) as per USFDA and EU requirements.
12. Cleaning Validation(Based on PDE,TDD, Matrix and Induvial Equipment’s) as per APIC,PDA,WHO,EU, ISPE and USFDA requirements.
13. Analytical Method development and validations as per ICH requirements.
14. Method transfer activities i.e. Product, Analytical methods as per USFDA and EU guidelines.
B. LEAD AUDITOR KEY STRENGTH:
– Prepare your electronic lab data to face Regulatory bodies smoothly with international qualities
– Provide best practices in Aquity UPLC to achieve increase your productivity.
– To give excellence on Six sigma,Lean six sigma,Quality management essentials as per current industry requirements
– To provide excellent on Data integrity Observations behalf of Labs and other core industry areas.
C. LIST OF POSTER PRESENTATIONS:
– ANALYSIS OF BULK DRUGS AND PHARMACEUTICAL FORMULATIONS BY ADOPTING SOME MODERN INSTRUMENTAL METHODS” in National poster symposium;” The royal society of chemistry (London) & centre for chemical sciences and technology, IST, JNTUH”, 24-12-2014.
– Advisory Editorial Board Member for Journal of Global trends in Pharmaceutical Sciences.
– Editorial Board Member for International journal of chromatographic Technologies.
– Advisory Board Member for European journal of Biomedical and Pharmaceutical Sciences.
E. KEY ACHIEVEMENT:
– Successfully faced USFDA, MHRA, UKRAINE&EU GMP(Hungary)
F. CURRENT COMPLETED VENDOR AUDITS:
– More than 40 Audits from the period of 2011 onwards.