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Product Certification

GMP Certification

Quick answer: Good Manufacturing Practices certification per WHO/Codex GMP guidelines — for pharma, food and cosmetics, 15-30 days

Available across all Gujarat districts & Dadra & Nagar Haveli, Daman & Diu
₹14,999Regular price

₹13,499

Gujarat offerSave ₹1,500 (10%)

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15-30 business days

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Audience

Who needs GMP Certification?

  • Pharmaceutical and API manufacturers targeting export markets
  • Food processing and packaged food manufacturers
  • Cosmetics and personal care product manufacturers
  • Dietary supplement and nutraceutical producers
  • Medical device manufacturers under ISO 13485 with GMP alignment
  • Ayurvedic and herbal medicine manufacturers under Schedule T
  • Biotech and biological product manufacturers

How it works

  1. 1

    GMP Scope Mapping

    Identify applicable GMP guideline — WHO TRS, Codex Alimentarius, Schedule M or PIC/S — based on product and target market.

  2. 2

    Gap Assessment

    Audit current manufacturing, QC and storage practices against the applicable GMP chapters and identify closure areas.

  3. 3

    System Documentation

    Prepare SOPs, MFRs, validation protocols, qualification records and contamination control procedures for audit readiness.

  4. 4

    Implementation

    Run the documented GMP system across production, QC and warehouse for 30-60 days with documented evidence before audit.

  5. 5

    Certification Audit

    GMP-accredited certification body conducts on-site audit covering premises, personnel, processes and quality systems.

  6. 6

    Annual Surveillance

    Yearly surveillance audit by the certification body maintains GMP compliance for the 3-year certification cycle.

Timeline

Day 1-7GMP Mapping + Gap Analysis
Week 2-6Documentation + Qualification
Week 4-10System Implementation
Day 15-25Certification Audit
Day 15-30Certificate Issued

Why file this

Benefits of gmp certification

  • Mandatory for pharmaceutical manufacturers supplying regulated markets
  • WHO TRS-aligned certification accepted by global regulatory bodies
  • Improves batch consistency and reduces product recall risk
  • Covers premises, equipment, personnel and process controls
  • Required for export of drugs, biologics and APIs to EU and US FDA markets
  • Schedule M compliance under Drugs and Cosmetics Rules 1945
  • Strengthens procurement eligibility with government hospitals
  • Annual surveillance keeps the system audit-ready year-round

Documents required

8 documents needed for gmp certification.

  • Manufacturing facility layout and cleanroom classification details
  • Master Formula Records (MFR) and Batch Manufacturing Records
  • Standard Operating Procedures for production, QC and storage
  • Equipment qualification and calibration records (IQ, OQ, PQ)
  • Water, HVAC and environmental monitoring records
  • Personnel training records and hygiene procedure evidence
  • Validation protocols for processes, cleaning and analytical methods
  • Drug/Product master file and stability study reports

Need help?

Talk to a GMP Certification expert — get answers in 4 working hours

DIY vs FinTax24

Why file gmp certification with FinTax24 instead of doing it yourself.

Comparison of DIY filing, local tax consultant, and FinTax24 across filing time, expert review, document check, support, and pricing.
AspectDIY / PortalLocal Tax ConsultantFinTax24
Filing time7–14 days (typical)Varies by availability and workload15-30 business days
Expert reviewNoneDepends on the consultantExpert verified on every filing
Document checkYou self-verify; rejected on portalManual review may varyPre-verified by our team before submission
SupportEmail / chatbotAppointment-based or office hoursWhatsApp + phone, Mon–Sat 10 AM–7 PM IST
PricingGovernment fees onlyConsultant fee + government feesTransparent: ₹4,999 + govt fees

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Frequently asked questions

What is GMP certification under WHO guidelines?

GMP certification under WHO guidelines verifies that pharmaceutical, food or cosmetics products are consistently produced and controlled to quality standards. The WHO TRS 986, Codex Alimentarius and PIC/S frameworks define the core GMP requirements globally.

How long does GMP certification take in India?

GMP certification takes 15-30 days after system implementation. First-time manufacturers should allow 60-90 days for documentation, validation, training and a mock audit before the certification body visit.

Is GMP mandatory for pharmaceutical manufacturers in Gujarat?

Yes, Schedule M of the Drugs and Cosmetics Rules 1945 mandates GMP compliance for all pharmaceutical manufacturers in Gujarat. WHO-GMP is required for export markets regulated by PIC/S member authorities.

What is the validity of a GMP certificate?

A GMP certificate is typically valid for 3 years subject to successful annual surveillance audits. Some jurisdictions like CDSCO accept the certificate for the full cycle if surveillance is current.

What is the difference between GMP and ISO 9001?

GMP is a prescriptive manufacturing standard focused on product safety, hygiene and process validation. ISO 9001 is a generic QMS standard covering quality management across any industry. Many manufacturers maintain both.

Does GMP apply to cosmetics manufacturers?

Yes, GMP per IS 4011 and WHO cosmetics GMP applies to Indian cosmetics manufacturers under the Drugs and Cosmetics Act. ISO 22716 cosmetics GMP is the international benchmark accepted globally.

What is the cost of GMP certification in India?

GMP certification starts from ₹14,999 plus annual surveillance fee of ₹4,999. Final cost depends on facility size, product complexity and audit man-days allocated by the certification body.

Can a startup get GMP certified?

Yes, a startup can obtain GMP certification before commercial production by completing qualification, validation and mock audits. The certification body audits the system, not the production volume.

Need help?

Talk to a GMP Certification expert — get answers in 4 working hours

Sources & authority: For regulations on gmp certification, refer to FinTax24 Compliance Desk.

Last reviewed by: FinTax24 Compliance Desk · Reviewed on:

About FinTax24

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