GMP · QMS · CQV Consulting — Worldwide
Quality systems and validation programs built to withstand scrutiny.
Pharma GXP Global Consulting is the independent practice of Manoj Kumar Verma — 25 years leading Quality Management Systems and CQV programs across pharmaceutical, biopharmaceutical, and vaccine manufacturing, engaged by organizations across India, Southeast Asia, and beyond.
Career since 2002 · Inspection experience with USFDA, WHO-Geneva & CDSCO
At a glance
- 25 Years in Pharma, Biopharma & Vaccine Quality
- USFDA · WHO-Geneva · CDSCO Inspection Experience
- CQV Delivered — India · Thailand · Vietnam · UK
- Hepatitis-B Vaccine Tech Transfer, Cuba → India
Regulatory inspection experience with
- USFDA
- WHO-Geneva
- CDSCO
- EU-GMP / EMEA
- TGA
- ISO 13485 bodies
- 25
- Years in pharma, biopharma & vaccine quality
- 4
- Countries delivered: India, Thailand, Vietnam, United Kingdom
- 6
- Core consulting services
- 2002
- Career start — Panacea Biotec
Why Pharma GXP
Consulting shaped by 25 years on the factory floor and the audit table alike.
Dual Perspective
Two decades managing quality from inside manufacturing operations, and years delivering it as an external CQV and QMS specialist. That combination means recommendations that survive contact with a real production floor.
Inspection-Tested, Not Theoretical
Direct, hands-on support for USFDA, WHO-Geneva, CDSCO, and ISO 13485 inspections, with successful outcomes. I know what an inspector actually asks — not just what the guidance document says.
Cross-Modality Depth
OSD, oral liquid, injectable/sterile, biologics, and vaccine manufacturing — including a government vaccine facility and an international Hepatitis-B r-DNA technology transfer from Cuba to India.
Delivered Across Borders
CQV and QMS programs delivered across India, Thailand, Vietnam, and the UK. Engagements available worldwide, on-site or remote.
Services
Where I can help
QMS Design & Implementation
Building a Quality Management System from the ground up — Quality Manual through SOPs — aligned to GMP, ICH Q10, and ISO 9001:2015.
- Quality Manual and Quality Policy
- Site Master File (SMF)
- Tier I–III document architecture (Quality Manual → SOPs → BMR / BPR / work instructions)
QMS Audit & Review
Independent, line-by-line review of an operating QMS — so weaknesses surface on your terms, not a regulator's.
- Document-by-document QMS review report
- CAPA effectiveness and closure-quality review
- Deviation and change-control trend analysis
Gap Analysis & Audit Readiness
A dry run of your next regulatory inspection — mock audit, documentation review, and shop-floor walkthrough — so findings surface before the real one.
- Mock inspection in the style of your target authority (USFDA / WHO / EU-GMP / CDSCO)
- Facility and documentation gap report, classified critical / major / minor
- CAPA plan with owners and realistic timelines
CQV Documentation
Apex-level CQV governance through to execution — Master Plans, risk assessments, and URS-through-PQ protocols for facilities, utilities, equipment, and computerized systems.
- CQV Master Plan (CQVMP)
- System Level Impact Assessments (SLIA) and Quality Risk Assessments (QRA)
- URS, Design Qualification (DQ), FAT and SAT protocols
GMP Training
Structured, role-specific GMP training — from shop-floor operators to quality leadership — built around real deviations, not generic slide decks.
- Training needs assessment by role and function
- Role-based curriculum: operators, QA/QC, engineering, and management
- Classroom, on-site, or virtual workshop delivery
GMP Lectures
Focused, single-session lectures and webinars on GMP, QMS, or CQV topics — for conferences, internal quality forums, or academic programs.
- A custom lecture on a chosen topic — e.g. CAPA effectiveness, data integrity, CQV fundamentals, technology transfer, or audit readiness
- In-person or virtual delivery
- Q&A or panel participation
Career highlights
Two and a half decades, in brief.
2025 — Present
Manager – QA
Sangama Engineering · Bengaluru, India
Managing QMS to ISO 9001:2015 and ICH Q10; overseeing quality of materials and services supplied to pharmaceutical clients.
2024 — 2025
Manager – Validation & QA
NARA Plus Consult · Bangkok, Thailand
Supervised execution of CQV protocols for black/clean utilities, process equipment, and CSV at a government-owned pharmaceutical manufacturing site; reviewed and approved URS, FAT, SAT, IQ, OQ, and RTM documentation.
2019 — 2024
Manager – Validation & QA
Biopharmax India Pvt. Ltd. · Pune, India
Spearheaded CQV master plans and risk assessments (CQVMP, SLIA, QRA); directed CQV protocol execution across black/clean utilities, process equipment, and CSV; delivered international CQV projects for biopharma facilities in Thailand and led commissioning & qualification of a sterile manufacturing facility in Newcastle, UK.
2019
Consultant
Navigene Genetics Science Pvt. Ltd. · Thane, India
Established quality systems and led calibration/validation activities; supported NABL accreditation for laboratory operations.
Let’s talk
Preparing for an inspection, or setting up a new facility?
Let's talk about where your quality system stands today, and what it needs before your next milestone.