GMP Consultants for Manufacturing Facilities: Pharma, Nutraceutical & Medical Devices
We help manufacturers design, qualify and run GMP-compliant facilities: layout and cleanroom design, equipment and process validation, documentation and data integrity, mock inspections and responses to FDA, EU, WHO and national regulator findings.
What do GMP consultants do?
Good Manufacturing Practice (GMP) makes sure products are made consistently to the right quality, every batch. It covers your premises, utilities, equipment, people, processes, materials and records.
GMP consultants help you get this right on the shop floor, whether you are building a new plant, upgrading an existing one, preparing for an inspection or recovering from findings. We work across medicines, dietary supplements and medical devices, for the US, EU, UK, India and WHO markets.
GMP frameworks by product and market
Your product type and target markets decide which GMP rules your site must meet.
| Framework | Applies to | Inspected by |
|---|---|---|
| US FDA cGMP (21 CFR 210 & 211) | Finished pharmaceuticals | FDA |
| 21 CFR 111 | Dietary supplements and nutraceuticals | FDA |
| 21 CFR 820 QMSR | Medical devices | FDA |
| EU GMP (EudraLex Volume 4) | Medicines for the EU market | EU national competent authorities |
| PIC/S GMP Guide | Medicines in PIC/S member countries | PIC/S participating authorities |
| WHO GMP | Medicines for WHO prequalification and many national markets | WHO and national regulators |
| Revised Schedule M | Medicines manufactured in India | CDSCO and State Licensing Authorities |
How we make your site GMP-ready
From first walkthrough to a site that passes inspection.
- 1
GMP gap audit
WalkthroughWe audit your site, systems and records against the GMP rules for your products and markets.
- 2
Facility & layout design
Flows · cleanroomsWe design material, personnel and waste flows and cleanroom zoning to ISO 14644.
- 3
Qualification
DQ · IQ · OQ · PQWe plan and review qualification of facilities, utilities such as HVAC and water, and equipment.
- 4
Validation
Process · cleaning · CSVWe support process, cleaning and computer system validation.
- 5
Documentation & data integrity
SOPs · ALCOA+We write SOPs and batch or device records and put data integrity controls in place.
- 6
Training & mock inspection
ReadinessWe train your team and run a mock regulatory inspection.
- 7
Inspection support
483 · Warning LettersWe support you during inspections and write responses to observations.
GMP areas we cover
Common GMP inspection findings
Our GMP consulting services
GMP consulting FAQs
What is GMP?
Good Manufacturing Practice (GMP) is the set of rules that makes sure products are consistently made and controlled to the right quality standards. It covers premises, equipment, people, processes, materials, documentation and testing.
What is the difference between GMP and cGMP?
cGMP means current Good Manufacturing Practice, the term the US FDA uses. The “current” reminds manufacturers to use up-to-date technologies and systems, not just the minimum written in older guidance.
Which GMP rules apply to my product?
It depends on the product and market. In the US, drugs follow 21 CFR 210 and 211, dietary supplements 21 CFR 111 and medical devices the 21 CFR 820 QMSR. In Europe, medicines follow EU GMP (EudraLex Volume 4), and many countries follow PIC/S or WHO GMP. In India, medicines follow Revised Schedule M.
How long does a GMP facility layout project take?
For a new facility or a major modification, layout design and GMP review typically take 3 to 4 months, followed by construction, qualification and validation before production starts.
What is data integrity and ALCOA+?
Data integrity means records are complete, consistent and accurate throughout their lifecycle. ALCOA+ describes the principles: data should be attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available.
How quickly must I respond to an FDA Form 483?
FDA expects a written response within 15 business days of the inspection close-out. A clear, evidence-based response within that window can help avoid escalation to a Warning Letter.
Is your site ready for its next GMP inspection?
Send us your details using the form below and we'll arrange a free GMP gap discussion.
