Your Global Partner for GMP

Compliance
 About Tejisha

Registered office
Tejisha GxP Services was founded in #709, Manjeera Majestic
Hyderabad, India by Industry Experts to Commercial
provide comprehensive support in handling Kukatpally, Hyderabad
Supplier Qualification and Management 500085 India
Activities on the global scale, on behalf of [email protected]
our esteemed clients. GST: 36AZKPJ5095P1ZI

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 Mission

Our Mission:
Timely, Compliant & Cost-
Effective
Timely Delivery
We ensure prompt service delivery for all client needs.

GMP Compliant
All services adhere to Good Manufacturing Practices.

Cost-Effective
We provide competitive pricing for our high-quality services.

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 Why Choose Tejisha GxP Services?

Expert Network
50+ experienced GMP auditors worldwide, including ex-regulatory inspectors.

Certified Quality
ISO 9001-2015 Quality Management System certified.

Competitive Pricing
Cost-effective solutions compared to industry competitors.

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 Comprehensive Audit Solutions

Turnkey Solution
From scheduling to CAPA management.

Broad Expertise
Auditing all pharmaceutical processes.

Quality Review
Reports reviewed by two independent peers.

Defined Timelines
Clear timelines for reports and follow-ups.
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Our Clients

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 Global Auditors Network
Name of the auditor Current Residence Education Experience Expertise Certifications No. of audits
Luis Charles Chavarria USA Graduate in Biology 44+ Years APIs / Drug Products / Medical devices Ex-FDA investigator 400+
HenryJ Anderson USA MSC 35+ Years APIs / Drug Products / Medical devices ASQ-CQA & ASQ-CSQP 400+
Chirag Patel USA MS 14+ Years APIs / Drug Products ASQ-CQA 300+
Mohammed Yousffi USA B.Sc. QA 19+ Years APIs / Drug Products / Medical devices ASQ-CQA 100+
Robert Fennon USA B.Sc 40+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 500+
Ganesh Nanduri USA M.Sc 18+ Years APIs / Drug Products / Medical devices IRCA & APIC Certified auditor 400+
Petro Shoturma Ukraine M. Pharma 18+ years APIs / Drug Products / Medical devices Certified GMP Auditor 400+
Francis Fernandes UK PhD in pharmacy 23+ years APIs / Drug Products / Medical devices Certified GMP Auditor 600+
Murat Avci Turkey Chemical Engineer 29+ Years Pharmaceuticals, cosmetics Certified GMP Auditor 25+
Ebru Mert Turkey M.Sc 26+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 380+
SvitlanaYakymenko Switzerland M.Sc. 18+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 200+
Steven Wing Cheung Switzerland B.Eng 30+ Years APIs / Drug Products / Medical devices IRCA & APIC Certified auditor 100+
Maxim Bunomovich Spain Doctor of Medicine 19+ Years Sterile Formulations & Clinical MRQA & MSQA 200+
Juan Carlos Gracia Spain B.Sc. 30+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 250+
Sung Hwan Yoon South Korea B.Sc. 14+ Years APIs / Drug Products Certified Lead Auditor 50+
Yvonne Li Singapore B.Sc. QA 20+ Years APIs / Drug Products / Medical devices GPVP Clinical & GPVP Post marketing 180+
Adriana Molana Murcio Oman M.Sc. MBA 24+ Years APIs / Drug Products / Medical devices Ex-Regulatory inspector 500+
Michael Bonett Italy B. Pharma 24+ Years APIs / Drug Products / Medical devices IRCA-Lead Auditor 250+
Alessandro Manni Italy M.Sc PhD 20+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 150+
Donata Pezzuto Italy PhD MBA 30+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 300+
Karen Ginsbury Israel M.Sc. 39+ Years APIs / Drug Products Certified GMP Auditor 500+
Christoph Wambach Germany PhD in chemitry 25+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 280+
Khatuna Gabisiani Georgia M.Pharma, PhD 30+ Years APIs / Drug Products / Medical devices Ex-Regulatory inspector 200+
Natia Urushadze Georgia M.Sc 15+ Years APIs / Drug Products / Medical devices Ex-Regulatory inspector 300+
Bahram Daneshvar Denmark PhD in protien chemistry 25+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 100+
Josipa Ljubicic Croatia M.Sc. 21+ yeasr Sterile Formulations & Clinical Certified GMP Auditor 200+
David Liao China B Tech Chem. Engg 20+ Years APIs / Drug Products / Medical devices APIC certified & ASQ Quality Auditor 240+
Rajasekhar Reddy Gatla China M.Sc. 17+ Years APIs / Drug Products / Medical devices IRCA & APIC Certified auditor 250+
Vito Zhou China B.Sc 19+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 400+
Durga Prasad China M.Pharma 15+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 250+
Sueli Ogata Brazil B.Pharma MBA 32+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 200+
Miriam Seike Brazil M.Pharma 25+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 200+ 7
Glaucia Karime Braga Brazil PhD 24+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 300+
 Indian Auditors Network
Name of the auditor Current Residence Education Experience Expertise Certifications No. of audits
Balaji Kuzhandhaivelu India PhD & MBA 23+ Years APIs / Drug Products / Medical devices ASQ-Quality Auditor & ASQ-GMP 250+
Kasi Viswanatha Raju India M.Sc. 18+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 200+
M. Vinod Babu India M.Sc. 33+ Years APIs / Drug Products / Medical devices APIC certified 120+
Sudheer Amidhepuram India M.Sc MBA 21+ Years Sterile Formulations AQS Quality Auditor 200+
Priyanka Siddhpura India B. Pharma 14+ Years API CQI-IRCA-Lead Auditor 100+
Vipan K Sharma India M.Sc. 19+ Years APIs / Drug Products / Medical devices CQI-IRCA-Lead Auditor 200+
Kamal Jeet Singh India M. Sc. 20+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 50+
Vilas Kurumbhatti India B.Sc Microbiology 40+ Years API IRCA-Lead Auditor & HACCP 150+
Mithilesh Trivedi India Msc PhD 36+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 25+
Bhagawat Makwana India B.Sc 38+ Years API Certified GMP Auditor 20+
Kumari Sunnita India M.Sc. 21+ Years APIs / Drug Products / Medical devices IRCA-Lead Auditor 100+
Vasundhara Iyengar India B.Pharm 33+ Years APIs / Drug Products / Medical devices IRCA-Lead Auditor 100+
Satish Joshi India M.Sc. 28+ Years APIs / Drug Products / Medical devices Certified GMP Auditor 100+
Venu Gopal Reddy India M. Sc. 18+ Years APIs / Drug Products / Medical devices IRCA-Lead Auditor 100+
Suman Rao B India M. Sc. (PhD) 25+ Years APIs / Drug Products / Medical devices IRCA-Lead Auditor 100+
Srikanth India B. Pharma 18+ Years APIs / Drug Products / Medical devices IRCA-Lead Auditor 100+
Satish Deshmukh India B.Sc. 35+ Years APIs / Drug Products / Medical devices IRCA-Lead Auditor 250+

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 Gap Assessment / Due Diligence audits

 Thorough and comprehensive evaluation

 Identification of the gaps between current practices and regulatory / quality / business

expectations

 Conducted jointly by GMP experts and a commercial / legal teams

 GMP expert team focusses on all systems of GMP

 Commercial team focusses on business, financial, and operational feasibility

 Defined deliverables – finding gaps, categorization, risk ratings, remediation plan and

readiness scoring.
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 Gap Assessment – Focus areas of GMP Experts
Quality Management System (QMS) Facility and Equipment
SOPs: availability, version control and Facility design (flow of personnel, materials,
adherence waste)
Change control system HVAC qualification and environmental
controls
Investigation / CAPA management
Risk management practices (ICH Q9 Equipment qualification (IQ/OQ/PQ)
compliance)
Manufacturing and Packaging Sterility
Calibration &Assurance (if applicable)
Preventive maintenance
programs
Batch manufacturing records (BMR/BPR) Cleanroom classification and monitoring
compliance
Aseptic process simulation (media fills)
Line clearance procedures
Gowning qualification
Process validation status
Sterilization validation (autoclaves, dry
Packaging integrity and control mechanisms heat)
Laboratory Controls Material and Vendor Personnel
Management
Raw material and finished product GMP training and retraining
testing Vendor qualification and periodic programs
review
Analytical method validation Qualification of key personnel
Raw material traceability
Out-of-specification (OOS) handling Awareness of current regulatory
Warehousing and storage trends
Data integrity in QC labs (e.g., audit
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trails) Approach for training effectiveness
Thank You!
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