ISO 15378 Certification in India
ISO 15378:2017 · Primary Packaging for Medicinal Products · typical timeline 8–16 weeks
ISO 15378 certification is the GMP-based quality standard for primary pharmaceutical packaging — bottles, vials, blisters, foils, closures, tubes. Pharma customers in Baddi, Ahmedabad and Hyderabad increasingly make it a vendor requirement. Cost: ₹70,000–₹2,50,000; timeline 2–4 months.
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Who needs ISO 15378 certification
- Blister foil, PVC/PVDC film and laminate makers
- Glass and plastic bottle, vial and ampoule producers
- Rubber stopper, closure and cap manufacturers
- Printed carton and label suppliers to pharma
ISO 15378 requirements in plain words
- ISO 9001 requirements plus GMP for packaging
- Contamination control, hygiene and clean-room zoning
- Validation of processes and change control
- Traceability of batches and raw materials
- Risk management and deviation handling
- Customer specification compliance and complaint handling
Certification process
- Step 1Gap assessmentWe audit your current processes against the standard and list exactly what is missing.
- Step 2DocumentationPolicies, procedures, records and formats written for your plant, not copied templates.
- Step 3Implementation & trainingYour team trained on the floor; internal audit and management review done with you.
- Step 4Certification auditStage 1 and Stage 2 audit by an IAF-accredited certification body of your choice.
- Step 5Certificate & surveillanceCertificate issued; we support annual surveillance audits for the full 3-year cycle.
ISO 15378 certification cost in India
Indicative 2026 all-inclusive prices — consulting, documentation, training and the certification-body audit fee. No separate charges. Full cost breakdown →
| Company size | All-inclusive price |
|---|---|
| Small (single line) | ₹1,10,000–₹1,80,000 |
| Mid (multi-line) | ₹1,80,000–₹3,20,000 |
| Large / multi-site | ₹3,20,000–₹6,00,000 |
Documents required
- Quality manual with GMP annex
- Hygiene, gowning and pest control procedures
- Process validation and change control records
- Batch records and traceability
- Deviation/CAPA logs
- Internal audit and management review records
Benefits
- Qualifies as approved vendor to pharma majors
- Reduces customer audits and rejections
- Aligns with customer GMP expectations
- Upgrade from ISO 9001 with limited extra work
Frequently asked questions
- Do we need ISO 9001 first?
- Not required, but ISO 15378 includes ISO 9001; an existing certificate halves the work.
- Is this the same as ISO 13485?
- No; ISO 13485 is for medical devices, ISO 15378 for pharma packaging.
- Validity?
- Three years with annual surveillance.
ISO 15378 consultants by city
- Baddi
- Ludhiana
- Mohali
- Chandigarh
- Delhi
- Gurgaon
- Noida
- Ahmedabad
- Mumbai
- Pune
- Bangalore
- Chennai
- Hyderabad
- Kolkata
- Indore
Written by Sahil Dubey, CISA — lead consultant, PraxisQ Consulting LLP. Reviewed October 2026.
Get a fixed-price quote in 24 hours
Tell us your industry, headcount and location. No retainer, no hidden certification-body fees.