Good Manufacturing Practices

GMP Certification

Ensure consistent product quality, safety, and regulatory compliance across manufacturing processes with globally accepted GMP certification.

🏭

Multiple Manufacturing Sectors Served

📋

Practical GMP Implementation Support

🛡️

Audit Support Till Certification

🌍

India & International Clients

GMP Certification Manufacturing Process

What is GMP Certification?

GMP (Good Manufacturing Practice) certification ensures that products are consistently manufactured and controlled according to defined quality standards. It focuses on hygiene, safety, process control, and documentation throughout the manufacturing lifecycle.

GMP certification is critical for industries where product quality directly impacts consumer health and safety. It minimizes risks such as contamination, mix-ups, deviations, and product recalls.

  • Ensures hygienic and controlled manufacturing
  • Reduces product rejection and compliance risks
  • Builds buyer, regulator, and export-market confidence

Why GMP Certification is Important

GMP certification is not optional for serious manufacturers. It directly impacts product safety, regulatory compliance, and market acceptance.

Without GMP Certification

  • High risk of contamination and quality failure
  • Frequent product rejections and recalls
  • No buyer or export market confidence
  • Regulatory non-compliance risk
  • Uncontrolled manufacturing processes

With GMP Certification

  • Consistent product quality and safety
  • Controlled and hygienic manufacturing
  • Buyer, regulator, and export trust
  • Reduced rejection and recall risks
  • Audit-ready documentation and traceability

Industries Covered under GMP Certification

GMP certification applies to a wide range of manufacturing industries where product quality, hygiene, and safety are critical.

💊

Pharmaceutical Manufacturing

Ensures safe, effective, and contamination-free drug production.

🍽️

Food & Beverage Processing

Maintains hygiene, food safety, and regulatory compliance.

🧴

Cosmetics & Personal Care

Controls formulation, cleanliness, and product consistency.

🌿

Nutraceuticals & Supplements

Assures quality, safety, and ingredient traceability.

🌱

Ayurvedic & Herbal Products

Standardizes traditional manufacturing with modern controls.

🩺

Medical Devices

Ensures precision, safety, and regulatory acceptance.

⚗️

Chemical & Healthcare Products

Maintains controlled processes and safety standards.

GMP Certification Requirements

GMP certification requires manufacturers to follow strict controls related to hygiene, processes, documentation, and quality assurance across operations.

Facility & Hygiene Control

Manufacturing premises must be clean, hygienic, well-structured, and designed to prevent contamination and cross-contamination.

Standard Operating Procedures (SOPs)

Documented SOPs are mandatory for all critical manufacturing, testing, and handling processes.

Raw Material & Supplier Control

Raw materials must be approved, tested, and sourced from verified suppliers with proper traceability.

Process & Quality Control

In-process checks and final quality inspections are required to ensure consistency and compliance.

Equipment Calibration & Maintenance

All equipment must be regularly calibrated and maintained to ensure accuracy and reliability.

Training & Personnel Competency

Employees involved in production must be trained in GMP practices and hygiene requirements.

Documentation & Record Keeping

Complete records must be maintained for manufacturing, testing, storage, and distribution activities.

Traceability & Recall System

A system must exist to trace each batch and recall products effectively if required.

GMP Certification Process

The GMP certification process follows a structured approach to ensure compliance with hygiene, quality, and manufacturing control requirements.

1

Gap Analysis

Assessment of the existing manufacturing setup to identify gaps against GMP requirements.

2

Documentation & SOP Preparation

Preparation of GMP-compliant documents, SOPs, and quality records based on actual operations.

3

Training & Implementation

Training of personnel and implementation of hygiene, process, and documentation controls on the shop floor.

4

Internal Review

Internal checks to verify implementation and close non-compliance before the final audit.

5

GMP Audit

Independent audit conducted to verify compliance with GMP requirements.

6

Certification Issuance

Issuance of GMP certificate after successful audit and closure of observations.

Why Choose DSB CERT for GMP Certification?

GMP certification is a serious compliance process. Choosing the wrong partner leads to rejection, delays, and repeat audits. DSB CERT focuses on practical implementation — not paperwork shortcuts.

  • Industry-specific GMP guidance based on actual manufacturing practices
  • Practical documentation aligned with on-ground operations
  • End-to-end support from gap analysis to certification issuance
  • Clear process, realistic timelines, and transparent communication
  • Support beyond audit to maintain ongoing GMP compliance

What You Can Expect

✔ No false promises or shortcut certifications

✔ Audit-ready systems, not cosmetic documents

✔ Compliance approach accepted by buyers and regulators

Frequently Asked Questions (FAQ)

Common questions related to GMP certification, process, compliance, and audit requirements explained clearly.

What is GMP certification?
GMP (Good Manufacturing Practice) certification ensures that products are consistently manufactured and controlled according to defined quality, hygiene, and safety standards across the manufacturing process.
Is GMP certification mandatory in India?
GMP certification is mandatory or strongly expected for regulated industries such as pharmaceuticals, food, cosmetics, medical devices, and healthcare manufacturing, especially for exports.
How long does it take to get GMP certified?
The GMP certification process generally takes 7 to 20 working days, depending on the size of the manufacturing unit, documentation readiness, and audit scheduling.
What documents are required for GMP certification?
Key documents include business registration, SOPs, hygiene procedures, process flow charts, quality records, monitoring logs, and corrective action records.
What is the validity of GMP certification?
GMP certification is typically valid for 1 to 3 years, subject to surveillance or renewal audits conducted by the certification body.
Is GMP different from ISO certification?
Yes. GMP focuses on product quality, hygiene, and manufacturing control, whereas ISO standards focus on management systems and organizational processes.
Can small manufacturing units apply for GMP certification?
Yes. GMP certification is applicable to small, medium, and large manufacturing units, provided hygiene, documentation, and process controls are properly implemented.

Ready to Get GMP Certified?

Get complete GMP certification support including documentation, implementation guidance, and audit assistance from experienced consultants.

✔ Expert GMP Consultants ✔ End-to-End Documentation ✔ Audit Support & Faster Certification