GMP Certification in India, USA and UK

Our GMP Certification and Compliance Consulting Services

What Is GMP Certification?

Good Manufacturing Practice (GMP) is a set of rules that makes sure products are made and controlled consistently to the quality their use requires. It covers premises, equipment, people, materials, processes, documentation, complaints and recalls.

A GMP certificate is written confirmation, issued after an inspection or audit, that a manufacturing site meets the GMP rules that apply to it. Depending on the country, it can come from a regulator, such as CDSCO or a State Licensing Authority in India or the MHRA in the UK, or from an accredited certification body as a voluntary certificate. In the USA, the FDA checks GMP through inspections but does not issue routine GMP certificates. Which one you need depends on your product, your country and your customers.

Which GMP Rules Apply in India?

India has separate GMP requirements for each product type.

Manufacturers that export also need to meet the GMP rules of their target markets, such as US FDA cGMP, EU GMP or PIC/S.

Revised Schedule M for Pharmaceutical Manufacturers

The Ministry of Health notified the revised Schedule M at the end of December 2023. It brings Indian drug GMP much closer to WHO-GMP and PIC/S standards. Larger manufacturers had to comply first, and the extended deadline for smaller units ran to the end of 2025, so the revised rules now apply to all licensed drug manufacturers.

Key additions include:

• A pharmaceutical quality system and quality risk management
• Product quality reviews
• Stronger validation and qualification of equipment, utilities and processes
• Control of computerised systems and data integrity
• Better supplier qualification and change control

Our consultants audit existing plants against revised Schedule M and help close the gaps before the next inspection.

GMP for Medical Device and IVD Manufacturers in India

Under the Medical Devices Rules, 2017, every device and IVD manufacturer needs a manufacturing licence, and the site must meet the quality management system requirements in the Fifth Schedule. These follow ISO 13485 closely, so most manufacturers build one system that covers both.

Class A and B devices are licensed by the State Licensing Authority, usually after an audit by a registered notified body. Class C and D devices are licensed by the Central Licensing Authority (CDSCO) after inspection. We prepare the QMS documents, the device master file and the plant master file, and support you through the audit. See our ISO 13485 consulting page for certification support.

WHO-GMP Certification and COPP for Exports

Pharmaceutical exporters are often asked for a WHO-GMP certificate and a Certificate of Pharmaceutical Product (COPP). In India these are issued after a joint inspection by CDSCO and the State Licensing Authority under the WHO certification scheme.

We prepare the site master file, check your plant against WHO-GMP guidelines, and help you respond to inspection observations. For US markets, see our FDA QMSR and 21 CFR 211 consulting page.

Who Issues GMP Certification in India?

• State Licensing Authorities (State FDAs) inspect and license drug, device (Class A and B) and cosmetic manufacturing sites, and can issue GMP certificates for drug units.
• CDSCO licenses Class C and D medical devices and joins the State FDA for WHO-GMP/COPP inspections.
• FSSAI licenses food and nutraceutical businesses against its hygiene and GMP schedule.
• Accredited certification bodies issue voluntary GMP certificates, often against WHO-GMP, ISO 22716 or similar standards, which some customers ask for.

A voluntary certificate does not replace a regulatory licence. We help you work out which approvals your products and customers actually need.

GMP Certification in the USA

In the United States, GMP is called current good manufacturing practice (cGMP) and is set by the FDA in Title 21 of the Code of Federal Regulations.

The FDA does not issue a routine "GMP certificate". It registers facilities and inspects them, and the outcome of the inspection is the evidence of compliance. For exports, the FDA can issue export certificates such as a Certificate to Foreign Government. Many US companies also hold voluntary GMP certificates from accredited certification bodies because customers ask for them.

We prepare US and foreign sites for FDA inspections, run gap audits and help with Form 483 responses. See our FDA QMSR and cGMP consulting, US FDA registration and US FDA Agent pages.

Official sources: 21 CFR Part 211 (drugs) and 21 CFR Part 111 (dietary supplements) on eCFR.

GMP Certification in the UK

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates GMP for medicines. UK GMP follows the same principles as EU GMP, and manufacturers and importers of medicines need an MHRA manufacturer's licence. After a successful inspection, the MHRA issues a GMP certificate for the site, and it inspects licensed sites again on a risk-based schedule.

We support UK manufacturers and overseas sites supplying the UK with gap audits, documentation and inspection readiness. Device makers can also use our UK Responsible Person service.

GMP Certification Process

1. Identify the rules. Confirm which GMP requirements apply in India, the USA, the UK or your other markets.
2. Plan the facility. Design or review the layout, cleanroom classes and utilities.
3. Write the documents. Quality manual, SOPs, specifications, batch records and site master file.
4. Implement and validate. Follow the procedures, keep records and complete qualification and validation.
5. Train staff. GMP and job-specific training with records.
6. Internal audit. Find and close gaps before the regulator does.
7. Apply and get inspected. Submit the licence or certificate application and host the inspection by CDSCO, the State FDA, the US FDA, the MHRA or a certification body.
8. Close observations. Respond to any findings and receive the licence or certificate.

How Long Does GMP Certification Take?

A new facility takes longer, because design, construction and qualification come first. Our facility design work alone has a minimum timeline of 30 days.

GMP Certification Cost in India, the USA and the UK

There is no fixed price for GMP certification in any of these countries. The total depends on:

• Shop floor area and number of locations
• Number of employees and shifts
• Type and number of products manufactured
• Whether the facility is new or already operating
• Which certificate is needed: regulatory licence, WHO-GMP or voluntary certification

The main cost heads are:

• GMP consulting and documentation fees
• Government fees for licences and inspections (for example in India and the UK), or audit and certificate fees for a certification body
• Auditor travel and accommodation
• Facility upgrades, equipment, qualification and validation

For most existing plants, facility upgrades are the largest cost. That is why getting the design right early saves the most money.

GMP Facility Design for Drugs, Devices, Food and Cosmetics

Designing and building a cleanroom facility is expensive, and mistakes are hard to fix once the plant is running. Our consultants have long experience in pharmaceutical and medical device plants and plan the facility with your products, target markets and future expansion in mind.

Each design aims for:

• Compliance with Indian and international regulators
• One-way flow of people, materials and finished products
• Lean manufacturing and good use of limited space
• Easy access to materials and consumables

Common questions we answer at this stage include the right cleanliness class for each room, how to design the air handling system, what water quality you need and how to treat it.

Related guides: clean room standards and classification, HVAC for cleanrooms and GMP stem cell facilities.

What Our Facility Design Includes

We do not provide detailed engineering, procurement, construction management or on-site qualification and validation. We can recommend partners for these and train your team on validation.

GMP Documentation and Training

After the facility, documentation is where most GMP projects succeed or fail. We prepare:

• QA and QC procedures
• Raw material, packaging material, in-process and finished product specifications
• Equipment cleaning procedures and manufacturing batch records
• Stability protocols
• Site master file to PIC/S and Indian requirements

Training covers SOPs for QA, QC, manufacturing and maintenance, process validation, installation and operational qualification, method validation, purified water validation, good laboratory practice, statistical process control and how to face regulatory audits.

GMP Facility Design Fees

Facility design is charged per square foot of facility area.

World-class facility design

For manufacturers planning US FDA approval or targeting OEM business worldwide.

GMP compliant facility design

For manufacturers making and selling their own products with GMP compliance.

Payment: 40% in advance, 30% after the concept drawing and the balance after the layout is finalised. Site visits by our consultants from India, the USA or the UK are billed at actual cost. Minimum timeline is 30 days, and taxes apply as per government rules. A final proposal is sent once we understand your project.

Planning One Facility for Several Markets

If you plan to sell in more than one country, design and document the plant for the strictest market from the start. Upgrading later is far more expensive.

• European Union: EU GMP for medicines, and ISO 13485 plus the MDR or IVDR for devices. See CE marking consultants.
• Several device markets: MDSAP covers device QMS audits for the USA, Canada, Brazil, Japan and Australia.
• Quality system: ISO 13485 is accepted as the base for device GMP in India, the USA, the UK and the EU.

Common GMP Inspection Findings

• Layouts that mix people, materials or waste flows
• HVAC systems that do not hold the required pressure differentials
• Water systems without proper validation or monitoring
• Incomplete batch records or missing signatures
• Equipment and processes used before qualification or validation
• Weak deviation, change control and CAPA records
• Data integrity gaps in QC instruments and software

GMP Consultants in India, the USA and the UK

Most documentation work is done remotely, with site visits for facility reviews, training and mock inspections.

Why Choose MedDeviceCorp as Your GMP Consultants?

• Consultants with years of hands-on work in pharmaceutical and medical device plants
• One team for facility design, documentation and training
• Indian, US, UK and EU requirements covered together
• Published facility design fees
• Offices in India, the USA and the UK
• Full addresses and contact details on our Contact page

GMP Certification FAQs