GMP · QMS · CQV Consulting — Worldwide
GMP quality systems and CQV validation programs built to withstand inspection.
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
Track record at a glance
- 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
Why work with an independent GMP and CQV consultant
Consulting shaped by 25 years on the factory floor and at the audit table alike — not by a methodology deck.
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
GMP, QMS and CQV consulting services
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
25 years in pharmaceutical quality and validation
Sangama Engineering
Bengaluru, India
Head – QA
Managing QMS to ISO 9001:2015 and ICH Q10; overseeing quality of materials and services supplied to pharmaceutical clients.
NARA Plus Consult
Bangkok, Thailand
Manager – Validation & QA
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.
Biopharmax India Pvt. Ltd.
Pune, India
Manager – Validation & QA
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.
Navigene Genetics Science Pvt. Ltd.
Thane, India
Consultant
Established quality systems and led calibration/validation activities; supported NABL accreditation for laboratory operations.
Insights
Explainers on GMP, QMS and CQV
CQV · 8 min read
What Is a CQV Master Plan?
A CQV Master Plan defines scope, boundaries, risk approach and release criteria for a validation programme. What goes in one, and five mistakes that sink it.
CQV · 7 min read
Commissioning vs Qualification
Commissioning is engineering; qualification is GMP evidence. What each covers, where they overlap, and what leveraging commissioning data really requires.
CQV · 8 min read
ASTM E2500 Explained
ASTM E2500 replaces checklist qualification with risk- and science-based verification. What it says, what a critical aspect is, and how it fits Annex 15.
FAQ
GMP and CQV consulting — common questions
The questions that come up most often before a first conversation.
What does a GMP consultant do?
A GMP consultant helps a pharmaceutical, biopharmaceutical or medical-device manufacturer meet Good Manufacturing Practice requirements. In practice that covers three distinct jobs: building or repairing the quality management system that governs the site, validating that facilities, utilities, equipment and computerized systems do what they are supposed to do, and preparing the organisation for regulatory inspection. Most engagements begin with an assessment of where the site actually stands rather than with a deliverable.
What is the difference between QMS consulting and CQV consulting?
QMS consulting is about the system of control: the Quality Manual, Site Master File, SOPs, CAPA, deviations and change control that define how a site manages quality over time. CQV consulting is about proving physical and computerized systems are fit for GMP use: URS, risk assessment, and the IQ/OQ/PQ evidence that a facility, utility, equipment item or software system performs as intended. A new facility needs both — the QMS governs the CQV programme, and the CQV records become QMS evidence.
Which regulatory standards do you work to?
ICH Q7 and Q10; WHO GMP; EudraLex Vol. 4 (EU GMP) including Annex 15; 21 CFR Parts 11, 210, 211 and 820; ISO 9001:2015, ISO 13485 and ISO 14644; GAMP 5; ASTM E2500; ASME BPE; and the ISPE Baseline Guide Volume 5 for commissioning and qualification. Inspection experience spans USFDA, WHO-Geneva, CDSCO and ISO 13485 certification bodies.
Do you work remotely or on-site?
Both, and most engagements mix the two. Documentation work — QMS architecture, protocol authoring, gap assessment against records, CAPA review — runs efficiently remote. Execution oversight, mock inspections, shop-floor walkthroughs and hands-on training need to be on-site, because the gap between a written procedure and actual practice is usually only visible in the room. Engagements have been delivered across India, Thailand, Vietnam and the United Kingdom, and are available worldwide.
What kinds of manufacturing sites do you work with?
Oral solid dosage, oral liquids, injectables and sterile manufacturing, biologics, and vaccines — including greenfield facilities preparing for first licensure, established sites recovering from an inspection finding, contract manufacturers formalising quality systems, and technology-transfer projects moving a process between sites or countries.
How does an engagement start?
With a conversation about your situation — the facility, the timeline, and what triggered the enquiry — not with a proposal template. Send a note through the contact page, by email or on LinkedIn, and you will get a reply within one to two business days with a view on where to start and whether this is the right kind of help for the problem.
Knowledge Booklet
CQV & QMS Knowledge Booklet
A technical module series on cleanroom design, HVAC, pharmaceutical water, WFI and GMP — written for the people who specify, deliver and defend these systems.
Browse the modulesLet’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.