I3CGGlobal is a globally recognised regulatory compliance consulting firm specialising in GMP Certification for manufacturers in the Food, Nutraceutical, Pharmaceutical, Cosmetics and Medical Device industries. Whether you are applying for a GMP Certificate for the first time or require expert consultancy to upgrade your facility to meet regulatory standards, our team of experienced consultants will guide you all the way from gap assessment to successful certification. We work with manufacturers in India, the UK and the USA and with clients across the world.

• Pharmaceutical manufacturers that need to be WHO-GMP or FDA cGMP compliant
• Food & nutraceutical manufacturers FDA 21 CFR Part 111
• Cosmetics manufacturers FDA 21 CFR Part 700 & EU Regulation 1223/2009
• Medical Device Manufacturers (FDA 21 CFR Part 820 / QMSR and ISO 13485)
• Drug and API Manufacturers (FDA 21 CFR Part 211)

• Export of pharmaceuticals or food products to USA, UK or European Union.
• Receiving purchase orders from hospitals, drugstore chains and institutional customers
• Becoming a supplier to multinational corporations
• Meeting the requirements of government tenders and public sector procurement
• Show commitment to quality to investors, auditors and end consumers

Manufacturers of dietary supplements and nutraceuticals in the United States must comply with FDA 21 CFR Part 111, which sets Current Good Manufacturing Practice (cGMP) requirements for the manufacture, packaging, labelling, and holding of dietary supplements.

The key requirements under 21 CFR part 111 are as follows:

• Staff hygiene programs and qualified personnel
• Physical Plant & Grounds Proper Design & Maintenance
• Qualification of equipment and utensils and their cleaning
• Process control and production Lab operations including raw material, in process materials and finished batch testing
• Master manufacturing records and batch production records
• Consumer complaint handling and product recall procedures

I3CGlobal provides end-to-end GMP consultancy for nutraceutical and food supplement manufacturers seeking FDA registration and cGMP compliance. Our consultants have on-ground experience in helping Indian exporters meet US FDA expectations for supplement GMP, gaining market access to lucrative US and UK markets.

FDA 21 CFR Part 211 outlines the cGMP requirements for finished pharmaceuticals manufactured for use in the United States. This regulation governs the manufacture of drug products and sets expectations for:

• Organisation and personnel
• Buildings and facilities
• Equipment
• Control of components, drug product containers, and closures
• Production and process controls
• Holding and distribution
• Laboratory controls
• Records and reports
• Returned and salvaged drug products

Global pharmaceutical businesses exporting to the USA must be fully compliant with 21 CFR Part 211 as determined by FDA facility inspections. I3CGlobal offers assistance to pharmaceutical producers in pre-approval inspections (PAI), pre-audit readiness programs, SOP documentation, and quality system creation and remedial support following FDA observations or Warning Letters. Our experts have assisted firms in meeting compliance at API, formulation and sterile manufacturing locations.

GMP Certification is part of an organization’s quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, cosmetics, pharmaceutical products, and medical devices till it reaches the point of use. The GMP Certification standards and guidance provide requirements for proper design, monitoring, and control of manufacturing processes and facilities.

Adherence to the cGMP regulations assures meeting specifications declared by the manufacturers by establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing and outsourcing controls in a neat and dedicated environment.

The recognised standard for medical device quality management systems is ISO 13485:2016. In the United States, medical device GMP is regulated by FDA 21 CFR Part 820, the Quality System Regulation (QSR), which is being transitioned to the Quality Management System Regulation (QMSR)

The essential components of GMP for medical devices are:

• Responsibility for Quality Planning and Management
• Design Controls & Risk Management Document & Record Controls
• Purchasing controls and supplier control
• Production and Process Controls
• Corrective Action and Preventive Action (CAPA)
• Internal Auditing
• Complaint management and MDR (Medical Device Reporting)
• Servicing and Installation

I3CGlobal provides dedicated consultancy services for 21 CFR Part 820 / QMSR compliance and ISO 13485 certification. Our consultants help medical device manufacturers in India and around the world to implement compliant Quality Management Systems, prepare for FDA inspections and achieve ISO 13485 certification, which is a prerequisite to CE Marking in Europe and market access in the UK and USA. For complete details, see our dedicated 21 CFR Part 820and QMSR pages.

Before applying for GMP Certification, your facility must have the following in place:

Infrastructure & Facility Requirements

• Shop floor layout appropriate for the nature of manufacturing, storage, and testing
• Environmental controls (temperature, humidity, cleanroom classification) maintained as per product specifications
• Dedicated areas for raw material storage, manufacturing, packaging, and quarantine
• Pest control and waste management systems

People & Training

• Qualified personnel with defined roles and responsibilities
• Role-based GMP training programmes with records
• Designated Qualified Person (QP) or Responsible Person where applicable

Documentation & Quality Systems

• Quality Manual and Quality Policy
• Standard Operating Procedures (SOPs) for all critical activities
• Batch Manufacturing Records (BMR) / Device History Records (DHR)
• Supplier qualification and incoming material testing records
• Calibration and preventive maintenance records

Validation & Testing

• Equipment qualification (IQ/OQ/PQ)
• Process validation and cleaning validation
• Analytical method validation
• Environmental monitoring data

Quality Oversight

• Internal audit programme
• CAPA (Corrective and Preventive Action) system
• Management review
• Change control system

I3CGlobal’s consultants will perform an initial GMP Gap Assessment against the applicable standard (WHO-GMP, FDA cGMP, or ISO 22716) and build a prioritised action plan tailored to your facility and timeline.

For Facilities Already Implementing GMP:

1. Gap Assessment against the applicable GMP standard
2. Remediation of gaps — SOPs, training, infrastructure upgrades
3. Internal audit by i3CGlobal consultants
4. CAPA resolution of internal audit findings
5. Application to the certification body or regulatory authority
6. Stage 1 document review
7. Stage 2 on-site inspection
8. Close-out of any non-conformities raised during inspection
9. Issuance of GMP Certificate

For New Facilities:

1. Facility design review and GMP layout planning
2. Selection of applicable GMP standard
3. Quality Management System development from scratch
4. SOP writing and documentation
5. Personnel recruitment guidance and training
6. Equipment procurement guidance (GMP-grade)
7. Validation master plan and execution
8. Internal audit and management review
9. Certification body application and inspection support
10. GMP Certificate issuance

I3CGlobal manages the entire process on your behalf, reducing your internal burden and significantly shortening the time to certification.