Associates

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Mr. Vikas H. Sathe - M.Pharm, MAM

WORK EXPERIENCE: 35 years of experience in management of formulation manufacturing operations and project management for new manufacturing facilities.

Core Experience in:
  • Designing & qualification of formulation manufacturing facilities
  • Manufacturing operations of wide spectrum for formulations
  • GMP compliance and regulatory audits.
Core Competency:
  • Designing and Operations of:
    • Isolator based manufacturing facility for Cytotoxic / high potency injectable formulations, including Lyophilized formulations.
    • Manufacturing facility for Aseptic or terminally sterilized Injectable formulations
    • Manufacturing facility for Oral Solid dosage forms – Tablets and capsules
    • Manufacturing facility for External Preparations (Ointments and Creams)
  • Upgradation of existing facilities for GMP compliance and productivity improvements
  • Designing of formulation manufacturing facilities
  • Preparation of URS for manufacturing facility and equipment
  • Preparation of Qualification documents: IQ/OQ/PQ
  • Equipment and facility qualification
  • Clean Room qualification and designing facility monitoring program
  • Developing equipment cleaning processes and Cleaning Validation
  • Risk Assessment and risk mitigation
  • GMP Training
  • Facility Audit and gap identification.
  • GMP compliance
  • Deviation investigation and root cause identification


    • n-k-khandelwal

    Mr. N. K. Khandelwal - Ph.D

    Mr.Nand Kishore khandelwal, Ph.D is a technical and competent professional, he has worked in various Pharmaceutical companies, in leadership positions in the area of Compliance, Quality Assurance, Quality Control, Microbiology, Technology Transfer, Audit & Validations, He has worked over 32 years with sterile parenterals ( including cytotxoic), non- sterile, oral solids, finished dosage and active Pharmaceutical ingredient manufacturing facilities before starting technical consultancy services in 2016. Presently, he is providing technical consultancy services to Pharmaceutical and Medical Devices companies located in India and Abroad on Quality Compliance, GMP Auditing, Due Diligence, FDA Remediation Qualification and Validations, GMP Training, Review of Aseptic Processing and Investigations, Review of Regulatory Filings Documents and Facility Designing. He is conversant with national and international regulatory guidance's.

    He has trained over 2000+ professionals on quality systems aseptic practices sterility assurance microbiology qualification and I validations conducted GAP Analysis and provided solutions to fall in line with current regulatory expectations.

    While working as a Head Quality with reputed Indian Pharmaceutical Organizations such as, Lupin Limited, Orchid Chemicals & Pharmaceuticals Ltd., Wockhardt Limited, Emcure Pharmaceuticals Ltd., Sri Krishna Pharmaceuticals Ltd. He has faced several health authority's inspections e.g., WHO, US FDA, UK-MHRA, Health 5 Canada, European Union (EU), TGA, SAHPRA, GCC, ANVISA, ISO etc to name a few. He is subject matter expert in aseptic processing, y sterility assurance, microbiology, quality A management system, risk assessment, investigations and having vast experience in responding to inspectional observations of regulatory agencies.

    Dr. Khandelwal earned a Ph.D in Microbiology and I member of various professional bodies including Parenteral Drug Association, USA. He has m travelled to USA, China, Asia, Europe, Korea and Oman on various assignments.



    bipin-patil

    Mr. Bipin Patil

    Mr. Bipin Patil is a technical and competent professional & he has 39 years' experience in HVAC & Contamination controls. He has expertise in Designing HVAC, Design of Cleanrooms, Special Purpose laboratories, HVAC & Cleanroom Performance Optimization & indoor Air Quality.

    He is running a Aerience (Institute of Air Science & Contamination Control) is a unique training Institute located in Pune (India), conducting training programmes for practicing engineers and engineering students (graduate as well as postgraduate) in HVAC.

    He trained professional every year in Sustainable Building Design and to fulfil the growing need for skilled manpower across India and narrow the gap between demand and supply.


    Professional Services

    • MEP Consultant
    • CFD Analysis
    • Cleanroom Design Consultation
    • Thermography, IAQ Audits, HVAC Performance Audits
    • Building Modelling
    • Cleanroom Performance Audits, and HVAC Training

    Hvac Design Consultation Using BIM

    • Better Collaboration and Communication
    • Model-Based Cost Estimation
    • Preconstruction Project Visualization
    • Improved Scheduling/Sequencing
    • Increased Productivity and Prefabrication
    • Reduced Cost and Mitigated Risk
    • Improved Coordination and Clash Detection

    Hvac Commissioning Management

    • Procurement Qualifications
    • Design Qualification
    • Installation Qualification
    • Testing & Commissioning
    • Operational Qualifications
    • Performance Qualification

    Performance Optimization

    • Solution For Field Performance Optimization
    • Cleanroom Performance Testing + Validation
    • Sustainablity Solutions For Operational Optimization
    • Faq Audits Complying To Leed V4 / Ashrae 62.1


    kumar-kurle

    Mr. Kumar Kurle – MSc Microbiology

    Mr. Kumar Kurle is a GMP Consultant and has over 23 years of experience in pharmaceuticals and biopharmaceuticals API and finished products.

    He has core experience in research and development, technology transfer and scale up, facility design, Recombinant cell line development & characterization, Toxicological GLP studies. Process validation, cleaning validation, Analytical method development and validation and Quality management in the areas of Biosimilars, Recombinant vaccines, monoclonal antibodies and plasma proteins.

    He has worked with reputed pharma/biopharmaceutical companies such as Cipla, Wockhardt, Gennova, Piramal and Dr. Reddy's. He has headed quality assurance department over 15 years. He is adept in statistical process controls, GMP trainings, investigations, Risk assessment and CAPA management.

    He has Strong subjective background of Chemistry, Biochemistry, Molecular Biology and Microbiology.



    prakash-deshmukh

    Mr. Prakash Deshmukh - M. Pharm

    Mr. Prakash Deshmukh is a Pharma Consultant in the company. He has 32 years of experience in Pharmaceutical Manufacturing of liquid injectables, lyophilized products, Oral Solid Dosages, Liquid Orals.

    He is expert in QMS, GMP Training, regulatory compliance, GMP auditing, Pharmaceutical Manufacturing, Qualification, Validation.He has worked with reputed Emcure Pharmaceuticals Ltd. / Gennova Biopharmaceuticals Ltd., Pfizer Ltd., M. J. Biopharmaceuticals Ltd.,Tata Pharma / Merind Ltd., Alembic Ltd.

    He has perfect planning and execution of GMP audits, Handling of Investigations, Deviations, Change Controls, SOPs, Qualification and Validation documentation, Regulatory audits (USFDA, MHRA, TGA): Regulatory compliance, remediation. Successfully leading of Manufacturing team handling day-to-day production operations of pharmaceutical formulations, Preparation and critical review of SOPs, BMR, BPR, MFR, Qualification Protocols, Qualification Reports, APQRS, SMF, VMP, audit responses.

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