GMP Certification
Get professional GMP Certification services with I-Pro Solutions. Transparent fees, fast turnaround, expert guidance.
Dedicated specialist
CA-led, named point of contact
Tracked client portal
Real-time status, end-to-end
Money-back accuracy
Refile-free if our error
Flat-fee pricing
No hidden charges, ever
About this service
GMP Certification provides statutory compliance and legal protection under the governing regulatory frameworks in India. Our specialist CA/CS team handles document drafting, eligibility verification, and direct authority filings from initiation to final certification.
Eligibility & thresholds
- Valid identity & address proof of applicant
- Active PAN & registered business premises
- Authorized representative authorization
- Compliant under applicable regulatory laws
- No pending statutory disqualifications
- Valid across authorized operational jurisdictions
- Pre-filing statutory documentation verification
- Official statutory fee schedule as per authority
- Mandatory periodic compliance filings post-approval
What's included
Everything in one transparent fee β no add-ons, no surprises.
Government charges only β separate from I-Pro's professional fee. All figures verified as of 25 August 2026.
| Fee Component | Amount (βΉ) | Basis / Authority |
|---|---|---|
| GMP Certification Statutory Fee | βΉ3,000 | Official government fee schedule (separate from professional fee)Statutory Authority |
| Total Government Fee | βΉ3,000 | (for default assumptions stated below) |
Government charges only β separate from I-Pro's professional fee. Verified 25 August 2026.
Required documents
Each list identifies exactly what to provide β and what you do not need to submit. Use the accordions to expand.
- βΊ**Site Master File (SMF)** β WHO TRS 961 Annex 14 format β description of the manufacturing facility β **Site Master File (SMF)** β WHO TRS 961 Annex 14 format β description of the manufacturing facility, location, layout, equipment, personnel, quality system;
- βΊ**Quality Manual** β overall quality policy and QMS documentation; β **Quality Manual** β overall quality policy and QMS documentation;
- βΊ**Standard Operating Procedures (SOPs)** β all GMP processes (raw material testing, manufacturing, p β **Standard Operating Procedures (SOPs)** β all GMP processes (raw material testing, manufacturing, packaging, QC, storage, distribution, deviation, change control, CAPA, internal audit, supplier qualification, customer complaint, recall);
- βΊ**Master Formula Records (MFR)** for each product β per Schedule M / WHO TRS Annex 4; β **Master Formula Records (MFR)** for each product β per Schedule M / WHO TRS Annex 4;
- βΊ**Batch Manufacturing Records (BMR)** for each batch; β **Batch Manufacturing Records (BMR)** for each batch;
- βΊ**Standard Test Procedures (STPs)** for raw materials, in-process, finished products; β **Standard Test Procedures (STPs)** for raw materials, in-process, finished products;
- βΊ**Specification sheets** β raw materials / packaging materials / finished products; β **Specification sheets** β raw materials / packaging materials / finished products;
- βΊ**Validation master plan** β process validation, cleaning validation, analytical method validation, β **Validation master plan** β process validation, cleaning validation, analytical method validation, equipment qualification (IQ / OQ / PQ);
- βΊ**Stability study data** β per ICH Q1A(R2) guidelines; β **Stability study data** β per ICH Q1A(R2) guidelines;
- βΊ**Personnel records** β qualification, training, medical fitness; β **Personnel records** β qualification, training, medical fitness;
- βΊ**Equipment list** with calibration and maintenance records; β **Equipment list** with calibration and maintenance records;
- βΊ**HVAC / water system / compressed air system qualification** records; β **HVAC / water system / compressed air system qualification** records;
- βΊ**Vendor qualification** records; β **Vendor qualification** records;
- βΊ**Annual Product Quality Review (APQR)** for each product; β **Annual Product Quality Review (APQR)** for each product;
- βΊ**Deviation / Change Control / CAPA** records. β **Deviation / Change Control / CAPA** records.
How it works
Each step is labelled with who performs it β Customer, I-Pro, or the Regulator. Form names are linked to the official portal.
- 1I-Proβ± 1 - 3 Days
Step 1: **I-Pro**
- 2I-Proβ± 1 - 3 Days
Step 2: **FBO / I-Pro**
- 3I-Proβ± 1 - 3 Days
Step 3: **I-Pro**
- 4I-Proβ± 1 - 3 Days
Step 4: **FBO**
- 5I-Proβ± 1 - 3 Days
Step 5: **I-Pro**
- 6I-Proβ± 1 - 3 Days
Step 6: **FBO / I-Pro**
- 7I-Proβ± 1 - 3 Days
Step 7: **Regulator Inspection**
- 8I-Proβ± 1 - 3 Days
Step 8: **Inspection**
- 9I-Proβ± 1 - 3 Days
Step 9: **Inspector's Report**
- 10I-Proβ± 1 - 3 Days
Step 10: **Certification**
- 11I-Proβ± 1 - 3 Days
Step 11: **I-Pro**
Post-registration compliance
What to file next. I-Pro handles these as part of the annual compliance package.
| Filing | Form | Deadline |
|---|---|---|
| Timely Statutory Renewal Penalty: Non-renewal leads to cancellation or statutory fines. | Periodic | Mandatory periodic renewal per regulator guidelines. |
Penalties for non-compliance
Statutory penalties under governing regulatory provisions. Avoid non-compliance delays.
| Non-compliance | Provision | Penalty |
|---|---|---|
| Timely Statutory Renewal | Periodic | Non-renewal leads to cancellation or statutory fines. |
Common mistakes to avoid
Avoidable filing errors that cause delays or rejection. Each can be resolved before submission.
- 1Mismatched applicant legal name or identity details across KYC proofsWhy: Government verification APIs cross-check with UIDAI and MCA databases and automatically flag discrepancies in spelling or dates.Fix: Our specialists pre-validate your documents against official government databases before portal filing.
- 2Submitting outdated utility bills or non-notarized commercial leasesWhy: Premises proofs older than 60 days or defective landlord NOCs trigger statutory scrutiny queries and multi-week processing delays.Fix: We verify recent billing dates and provide pre-formatted, legally vetted landlord NOC and lease formats.
- 3Selecting incorrect classification, turnover slab, or statutory activity codeWhy: Applications filed under inappropriate classifications attract show-cause notices and potential rejection without statutory fee refund.Fix: We conduct a statutory scope assessment to align your application with the exact regulatory requirements.
Frequently asked questions
Everything you need to know about this service.
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