GMP Certification – A Complete Overview
Good Manufacturing Practice (GMP) certification ensures that products are consistently produced and controlled according to quality standards to minimize risks involved in pharmaceutical manufacturing.
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Overview of GMP Certification
Good Manufacturing Practice (GMP) Certification is a globally recognized standard that ensures the consistent quality, safety, and efficacy of pharmaceutical products. It provides a comprehensive framework for managing all aspects of manufacturing and quality control, including production processes, testing procedures, and documentation.
Purpose of Good Manufacturing Practice
The primary goal of GMP is to minimize risks associated with pharmaceutical production—such as contamination, mislabeling, and incorrect dosages—by overseeing every aspect of the manufacturing process, from raw‑material sourcing and clean environments to equipment calibration and staff training.
GMP Guidelines for Certification Holders
WHO‑GMP guidelines serve as the foundation for national and regional regulations (EU, ASEAN, PIC/S). They promote a quality‑centric approach, helping manufacturers prevent contamination, reduce errors, and adapt the standards flexibly to their specific processes while ensuring consistent product quality.
Key Benefits of GMP Certification
● Enables adoption of industry best practices in production ● Ensures timely detection and resolution of quality issues ● Demonstrates compliance with national and international regulations ● Enhances brand credibility and consumer trust ● Reduces costs associated with recalls, rework, and penalties ● Supports global trade and export potential ● Lowers the frequency and duplication of regulatory inspections ● Drives long‑term operational efficiency and cost savings
Benefits for Manufacturers & Customers
Manufacturers gain robust quality systems and a culture of continuous improvement; customers gain assurance through in‑depth, multi‑day audits that verify a supplier’s ability to manage non‑conformities responsibly.
1. Documents Required for GMP Certification
● Company information: name, address, contact details
● Manufacturing License copy
● List of approved products and Site Master File (WHO TRS 823)
● Master Manufacturing Formula & process documentation
● Finished product specifications & analytical methods
● Stability study data (accelerated & real‑time) for ≥3 batches
● Process & method validation reports
● Personnel qualifications & regulatory approvals
● Equipment lists, SOPs, STPs, plant layout, water system schematic
● Product summary sheet (Format B)
● Evidence of safety & efficacy (Rule 158B, Drugs & Cosmetics Act, 1940)
● Undertaking of compliance with relevant Acts (1940, 1954)
Step‑by‑Step Process to Obtain GMP Certification
1. Application Submission to a recognized certification body
2. Review of application and eligibility
3. Gap analysis & fee agreement
4. Documentation review against GMP guidelines
5. Stage 1 audit (documented systems) & corrective actions
6. Stage 2 audit (on‑site implementation) & verification
7. Issuance of GMP Certificate (valid for 3 years)
8. Surveillance audits every 6–12 months
Costs & Penalties
Certification fees vary by body and scope. Non‑compliance penalties can include license suspension, production halts, fines, recalls, and legal action.
How DoStartup Helps You Get GMP Certified
1. Initial consultation & requirement gathering
2. Appointment of a legal/regulatory expert
3. Documentation preparation & gap analysis
4. Audit coordination & corrective action support
5. Post‑certification compliance and audit readiness