GMP Certification and Compliance Support in India
Get your facility, documentation and people ready for Good Manufacturing Practice, with an independent assessment of where you stand and what to fix.
Get a Free QuoteSee All CertificationsGood Manufacturing Practice is about making the same safe, quality product every time, and being able to prove it.
For pharmaceuticals in India it is also a legal requirement under the Drugs and Cosmetics Rules, checked by regulators, so preparation matters.
Since 2012
in ISO training, consulting and certification
Gap Assessment
of premises, documents and practices
Training Included
for your team
Clear Scope
we say what is and isn't a legal requirement
What is GMP?
Good Manufacturing Practice (GMP) is a set of requirements for how products are made, tested, stored and released so that they are consistently safe and of the intended quality. It covers premises and equipment, people and training, documentation, production controls, quality control, complaints and recalls.
GMP is not one single certificate. The requirements depend on your sector and market: pharmaceuticals (in India, the revised Schedule M of the Drugs Rules, and WHO GMP for many export markets), cosmetics (for example ISO 22716), food and food packaging, and medical devices (see ISO 13485).
We help you understand which GMP requirements apply to you, assess your site against them, close the gaps and prepare for inspections and customer audits.
What a GMP Certificate Does and Doesn't Mean
A licence is separate
In India, a drug manufacturing licence is granted by the licensing authority after inspection. A private assessment does not replace it.
Different schemes, different issuers
WHO GMP certificates for exports, and customer or regulator audits, are issued or carried out by specific bodies. We tell you which applies to you.
What we provide
Gap assessment, documentation support, staff training, mock audits and audit-readiness reviews, so you meet the real requirement first time.
Benefits of GMP Compliance
Safer, consistent products
Controlled processes reduce contamination, mix-ups and variation.
Inspection readiness
Be prepared for regulator, customer and export-market audits.
Fewer rejections and recalls
Catch problems at source, not after the product is shipped.
Access to markets
Meet requirements for tenders, contract manufacturing and exports.
Trained, accountable people
Clear roles, SOPs and records that people actually follow.
Documented control
Records that show what was done, when and by whom.
How We Work
Scope and requirements
We confirm which GMP requirements apply to your product, site and market.
Gap assessment
We assess premises, equipment, documents and practices against those requirements.
Corrective plan
We help you prioritise and close the gaps, including SOPs and records.
Train and mock audit
Staff training and a mock audit to test readiness.
Final review
A final readiness review before your inspection or customer audit.
Be Careful with Instant GMP Certificates
Some providers sell a “GMP certificate” with no real assessment. It will not satisfy a regulator or a serious buyer. Before choosing a provider, check that:
- Your site and records are actually assessed.
- The provider explains which GMP requirement applies and who issues any official approval.
- You are not promised a licence or regulator approval.
- You are not promised results in a day.
Frequently Asked Questions
What is GMP?
Good Manufacturing Practice is a set of requirements for making products safely and consistently, covering premises, people, documentation, production, quality control and complaints.
Is GMP mandatory in India?
For pharmaceutical manufacturing, GMP is a legal requirement under the Drugs and Cosmetics Rules (revised Schedule M). Requirements for other sectors depend on the product and the buyer. Check current deadlines and rules with your regulator.
Can you give us a GMP licence?
No. A manufacturing licence is granted by the licensing authority. We help you prepare for inspection and meet the requirements.
Which GMP applies to us?
It depends on your sector and markets, for example Schedule M, WHO GMP, ISO 22716 for cosmetics, or food GMP. Contact us and we will confirm the right scope.
How long does preparation take?
It depends on your site, product and current maturity. Contact us for a timeline for your organisation.
How much does it cost?
Cost depends on the size of your site, scope and the work needed. Contact us for a free quote.
Ready to Get GMP Certified?
Tell us about your organisation and we’ll reply with a clear plan and quote.
Contact Us