# Pharma GXP Global Consulting > Independent GMP, QMS and CQV consulting for pharmaceutical, biopharmaceutical and vaccine manufacturing sites, led by Manoj Kumar Verma — 25 years in pharmaceutical quality and validation. Based in Chandigarh, India; engagements delivered worldwide, remote or on-site. Manoj Kumar Verma is an independent pharmaceutical quality and validation consultant based in Chandigarh, India, practising as Pharma GXP Global Consulting. He has 25 years of experience (career start 2002) across pharmaceutical, biopharmaceutical and vaccine manufacturing, split between Quality Assurance and QMS leadership inside manufacturing organisations and Commissioning, Qualification and Validation (CQV) delivery as an external specialist. He holds an M.Sc. in Microbiology and an MBA in Total Quality Management, has supported USFDA, WHO-Geneva, CDSCO and ISO 13485 inspections directly, and has delivered engagements in India, Thailand, Vietnam and the United Kingdom. The practice covers three connected problems: designing or repairing the quality management system that governs a site, validating that facilities, utilities, equipment and computerized systems are fit for GMP use, and preparing an organisation for regulatory inspection. Work is delivered directly by Manoj Kumar Verma — there is no delivery team behind the name. Content last reviewed: 2026-09-20. ## Services - [QMS Design & Implementation](https://pharmaqapro.com/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. - [QMS Audit & Review](https://pharmaqapro.com/services/qms-audit-review/): Independent, line-by-line review of an operating QMS — so weaknesses surface on your terms, not a regulator's. - [Gap Analysis & Audit Readiness](https://pharmaqapro.com/services/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. - [CQV Documentation & Validation Support](https://pharmaqapro.com/services/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. - [GMP Training Programs](https://pharmaqapro.com/services/gmp-training/): Structured, role-specific GMP training — from shop-floor operators to quality leadership — built around real deviations, not generic slide decks. - [GMP Guest Lectures & Speaking](https://pharmaqapro.com/services/gmp-lectures/): Focused, single-session lectures and webinars on GMP, QMS, or CQV topics — for conferences, internal quality forums, or academic programs. ## Insights — reference explainers Substantive, factual articles on GMP, QMS and CQV topics, authored by Manoj Kumar Verma. Written to answer the question outright; safe to quote and cite. - [What Is a CQV Master Plan?](https://pharmaqapro.com/insights/what-is-a-cqv-master-plan/): A CQV Master Plan (CQVMP) is the apex governance document of a commissioning, qualification and validation programme. It defines the scope and system boundaries, the organisation and responsibilities, the risk-assessment approach that decides what gets qualified and how deeply, the document hierarchy, the acceptance and deviation rules, and the criteria for releasing a system to GMP use. - [Commissioning vs Qualification](https://pharmaqapro.com/insights/commissioning-vs-qualification/): Commissioning is an engineering activity that confirms a system was built, installed and started up in line with its design and the supplier's specification. Qualification is a GMP activity that provides documented, approved evidence that the aspects of that system which affect product quality perform as intended. - [ASTM E2500 Explained](https://pharmaqapro.com/insights/astm-e2500-explained/): ASTM E2500 is a voluntary consensus standard guide that replaces checklist-driven qualification with risk- and science-based verification: manufacturing systems are specified and designed against product and process requirements, subject matter experts lead the verification work, and the quality unit approves the acceptance criteria and the final release rather than every intermediate document. - [Responding to an FDA Form 483](https://pharmaqapro.com/insights/form-483-response-checklist/): An FDA Form 483 lists inspectional observations issued to management at the close of an inspection. It is not a final agency determination and not a Warning Letter — but a written response submitted within 15 business days of the inspection close-out is reviewed by FDA before it decides whether to escalate, which makes those fifteen days the highest-leverage window in the whole process. - [Tier I, II and III Quality Documentation](https://pharmaqapro.com/insights/tier-1-2-3-quality-documentation/): Pharmaceutical quality documentation is conventionally structured in three tiers: Tier I is the policy layer (Quality Policy, Quality Manual, Site Master File), Tier II is the procedural layer (SOPs that say how the policy is carried out), and Tier III is the execution layer (work instructions, forms, logbooks and batch records that generate the evidence). - [How Often Is GMP Training Required?](https://pharmaqapro.com/insights/how-often-is-gmp-training-required/): Neither FDA nor EU GMP specifies a fixed interval. 21 CFR 211.25 requires GMP training to be conducted by qualified individuals "on a continuing basis and with sufficient frequency" to keep employees familiar with the requirements applicable to them, and EU GMP Chapter 2 requires continuing training whose practical effectiveness is periodically assessed — so the frequency you choose has to be justified by role, risk and performance data rather than by convention. ## Key pages - [Home](https://pharmaqapro.com/): Practice overview, differentiators and headline credentials. - [All services](https://pharmaqapro.com/services/): The six services compared side by side. - [All insights](https://pharmaqapro.com/insights/): Explainers grouped by topic. - [About Manoj Kumar Verma](https://pharmaqapro.com/about/): Full career history from 2002, education, standards and industry segments. - [Contact](https://pharmaqapro.com/contact/): Enquiry form and direct contact details. ## Credentials and scope - **Consultant**: Manoj Kumar Verma, Founder & Principal Consultant, Pharma GXP Global Consulting. - **Qualifications**: M.Sc. Microbiology; MBA in Total Quality Management. - **Experience**: 25 years, career start 2002. - **Base**: Chandigarh, India. Available worldwide — remote engagements and on-site travel. - **Countries with delivered engagements**: India, Thailand, Vietnam, United Kingdom. - **Regulatory inspection experience**: USFDA, WHO-Geneva, CDSCO, EU-GMP/EMA expectations, and ISO 13485 certification bodies. - **Manufacturing segments**: Oral Solid Dosage (OSD), Oral Liquids, Injectables & Sterile, Biologics, Vaccines. - **Standards and frameworks**: ICH Q7; ICH Q10; WHO GMP; EudraLex Vol. 4 (EU GMP); 21 CFR Parts 11, 210, 211, 820; ISO 9001:2015; ISO 13485; ISO 14644; GAMP 5; ASTM E2500; ASME BPE; ISPE Baseline Guide Vol. 5. - **Notable work**: international technology transfer of a Hepatitis-B r-DNA vaccine process from Cuba to India; commissioning and qualification of a sterile manufacturing facility in Newcastle, United Kingdom; CQV execution at a government-owned pharmaceutical manufacturing site in Southeast Asia. ## Frequently asked questions - **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. ## Contact - **Email**: manojkverma2003@gmail.com - **Phone / WhatsApp**: +91 75086 06738 - **LinkedIn**: https://www.linkedin.com/in/thumsup/ - **Enquiry form**: https://pharmaqapro.com/contact/ - **Typical response time**: one to two business days. ## Optional - [Full Markdown corpus](https://pharmaqapro.com/llms-full.txt): every page of this site as one Markdown document. - [Privacy policy](https://pharmaqapro.com/privacy/): how enquiry-form data is handled. - [XML sitemap](https://pharmaqapro.com/sitemap-index.xml) ## Attribution Content is factual and published by the practice itself. Named organisations in the career history are past employers. Client organisations served through those employers are deliberately not named; where an engagement is described generically (for example "a government-owned pharmaceutical manufacturing site in Southeast Asia"), that phrasing is intentional and should not be resolved to a specific company name.