Nirdesh Kumar Raghav, pharmaceutical quality control expert

Deputy Manager, Quality Control · Acme Generics

Nirdesh Kumar RaghavPharmaceutical Quality Control Expert, Baddi, Himachal Pradesh

  • B.Pharm
  • Approved Analytical Chemist
  • US FDA-approved facility
  • Health Canada and EU-GMP audits, 2025

Fourteen years of pharmaceutical quality control across US FDA, Health Canada and EU-GMP regulated plants. Runs the general-block QC laboratory at a US FDA-approved facility and reviews DietXP's product-quality content.

DietXP batch certificates Meet all experts
  • 14+years in pharmaceutical quality control
  • 9regulatory inspections, including US FDA, Health Canada and EU-GMP
  • 27client audits faced
  • 0major or critical observations
Field
Pharmaceutical quality control and regulatory compliance
Employer
Acme Generics Pvt. Ltd., US FDA-approved facility
Based in
Baddi, Himachal Pradesh
Languages
English, Hindi
Profile updated
September 2026

About

About Nirdesh Kumar Raghav

Nirdesh Kumar Raghav is Deputy Manager, Quality Control, at Acme Generics' US FDA-approved facility in Baddi, Himachal Pradesh, where he acts as designee of the head of the General Block Quality Unit and reports to the cluster head of quality. He has more than 14 years in pharmaceutical quality control: laboratory operations, regulatory compliance and quality systems.

His career runs through five manufacturers, Acme Generics, Kusum Healthcare, Mankind Pharma, Ipca Laboratories and Psychotropic India, covering oral solid dosage forms (tablets and capsules), liquids, topicals, suspensions and injectables. He has taken facilities through one US FDA inspection, eight other regulatory inspections including Health Canada and EU-GMP, and 27 client audits by companies such as Merck, GSK, P&G, Dr. Reddy's, Biocon, Cipla and Abbott, with no major or critical observations.

He holds a Bachelor of Pharmacy from Gurukula Kangri University, Haridwar, and has been formally approved as an analytical chemist (instrumental and chemical) by the Licensing Authority and Drug Controller, Jaipur, since December 2020. On DietXP he reviews supplement, product-quality and health science content from a pharmaceutical quality and regulatory standpoint.

Expertise

Areas of expertise

  • Regulatory compliance
  • Analytical chemistry
  • LIMS and quality management systems
  • Oral solid dosage and injectables QC
  • Analytical method validation
  • Stability studies
  • OOS and deviation management
  • 21 CFR Part 11 data integrity
  • Laboratory leadership and budgets

Regulatory record

Inspections and audits

  • 1US FDA inspection
  • 8other regulatory inspections
  • 27client audits
  • 0major or critical observations
  • Regulators

    Health authorities faced

    US FDA, Health Canada, EU-GMP, CDSCO and PIC/S-aligned inspections. The 2025 Health Canada and EU-GMP audits at Acme Generics closed with no major or critical observations.

  • Client auditors

    Companies that have audited his laboratories

    Merck, P&G, GSK, JAMP, Dr. Reddy's, Biocon, Rubicon, Intas, Alkem, Cipla, Glenmark, Pinnacle, Aristo UK, Zydus, Strides, Sun, Viatris, Mankind Pharma, Abbott and Torrent Pharma.

Experience

Career

  1. Deputy Manager, General Block Quality Control

    Current

    Acme Generics Pvt. Ltd., US FDA-approved facility, Baddi, Himachal Pradesh

    August 2024 to present

    Designee of the head of the General Block Quality Unit, reporting to the cluster head of quality. Leads routine QC for tablets and capsules and the qualification of new projects; owns the life cycle of products, laboratory instruments and software; plans and monitors operating and capital budgets; site lead for LIMS integration with QC instruments; keeps the multi-regulatory contract-manufacturing site compliant with 21 CFR Part 11. Implements SAP, LIMS, LMS, Clean, Ample Logic, Lab Solutions, eLog and EDCS, and leads the internal and external audit programme. Cleared the 2025 Health Canada and EU-GMP audits with no major or critical observations.

  2. Deputy Manager, Quality Control

    Kusum Healthcare Pvt. Ltd., Bhiwadi, Rajasthan

    April 2017 to August 2024 · seven years

    Led the routine QC laboratory for tablets, capsules, liquids, topicals (ointments, creams, gels, shampoos) and suppositories. Group leader for finished products and metrology, and earlier for raw materials, packing materials, cleaning validation and method validation and remediation. Made usage decisions across finished, in-process, hold-time, raw and packing material testing, calibrations and qualifications. Implemented Caliber LIMS and QMS, Ample Logic, SAP, Empower 3 and Lab Solutions.

  3. Officer, Quality Control

    Mankind Pharma Ltd., Unit 2, Paonta Sahib, Himachal Pradesh

    June 2015 to April 2017

    Planned finished goods, in-process and process validation testing for tablets, capsules, liquids and soft gels. In charge of laboratory incident investigations (LIR, OOS, OOT), change controls for exhibit stability protocols and testing monographs, and cGMP documentation to PIC/S guidance; incidents filed through SAP.

  4. Officer, Quality Control

    Ipca Laboratories Ltd., Dehradun

    August 2014 to June 2015

    Qualitative and quantitative analysis of finished products, stability samples and raw materials to Ph. Eur., IP and BP for oral solid and injectable dosage forms; cleaning validation and water analysis; HPLC, GC headspace, UV, FTIR, dissolution and titration on Empower and Lab Solutions.

  5. Officer, Quality Control

    Kusum Healthcare Pvt. Ltd., Bhiwadi, Rajasthan

    February 2013 to July 2014

    Raw material analysis for oral solid, liquid and topical products by HPLC, GC, UV, dissolution, polarimetry, refractive index and FTIR; method validation; GLP records; instrument checks and pipette calibration.

  6. Junior Officer, Quality Control

    Psychotropic India Ltd., Haridwar, Uttarakhand

    August 2011 to February 2013

    Sampling and analysis of raw and packing materials; chemical and UV analysis of bulk and finished oral solid and injectable products; preparation and standardisation of volumetric solutions; daily balance verification and pH meter calibration.

Education

Education and approval

  • Undergraduate · 2011

    Bachelor of Pharmacy (B.Pharm)

    Gurukula Kangri University, Haridwar

  • Regulatory approval · December 2020

    Approved Analytical Chemist, instrumental and chemical

    Licensing Authority and Drug Controller, Jaipur, Rajasthan

  • Schooling · 2003 and 2005

    High school and intermediate

    Board of High School and Intermediate Education, Uttar Pradesh

Recognition

Awards

  • Acme Group · March 2025

    Mountain Movers, outstanding team award

    For the General Block Quality Unit's regulatory and operational performance.

  • Acme Group · August 2025

    Star of the Month

    Individual recognition for quality operations and regulatory readiness at the Baddi facility.

  • Acme Generics · 2025

    First prize, safety quiz, 54th National Safety Week

  • Kusum Healthcare · 2021 and 2024

    First prize, safety quiz, 50th and 53rd National Safety Weeks

  • Kusum Healthcare · August to September 2020

    Certificate of appreciation, employee wellness programme

Technical skills

Instruments, software and quality systems

  • Analytical instruments
    • HPLC
    • GC and GC headspace
    • UV spectrophotometry
    • FTIR
    • Dissolution
    • Titration
    • Polarimeter
    • Refractive index
    • pH meter
    • Analytical balance
  • Laboratory and quality software
    • Caliber LIMS
    • Oasis LIMS
    • Empower 3
    • SAP
    • Ample Logic
    • Lab Solutions
    • Chromeleon
    • EDS 365
    • Clean
    • eLog
    • EDCS
    • Compliance Wire
    • LMS
  • Regulatory and QMS
    • 21 CFR Part 11
    • cGMP, GLP, GCP
    • OOS, OOT, OOE
    • CAPA
    • Change control
    • APQR
    • Risk assessment
    • Stability studies
    • Process validation
    • Analytical method validation

FAQ

Questions about Nirdesh Kumar Raghav

Who is Nirdesh Kumar Raghav?
A pharmaceutical quality control professional with more than 14 years of experience. He is Deputy Manager, Quality Control, at Acme Generics' US FDA-approved facility in Baddi, Himachal Pradesh, where he acts as designee of the head of the General Block Quality Unit.
What are his qualifications?
A Bachelor of Pharmacy from Gurukula Kangri University, Haridwar (2011), and formal approval as an analytical chemist (instrumental and chemical) by the Licensing Authority and Drug Controller, Jaipur, Rajasthan, from December 2020.
What is his regulatory record?
Across Acme Generics, Kusum Healthcare, Mankind Pharma, Ipca Laboratories and Psychotropic India he has taken facilities through one US FDA inspection, eight other regulatory inspections including Health Canada and EU-GMP, and 27 client audits, with no major or critical observations.
What does he do for DietXP?
He reviews DietXP's supplement, product-quality and health science content from a pharmaceutical quality and regulatory standpoint. See the batch certificates and the NRGT lab report. He is an independent contributor; his views are his own and do not represent his employer.

Product quality

DietXP products come with published certificates of analysis

Batch certificates and laboratory test reports for NRGT and BAO Refresh are published on the site, product by product.

See batch certificates Browse the guides