9001MOST POPULAR
ISO 9001:2026
Quality management system
Rs 2,500 Rs 4,500
Non IAF CertificationFinal price. No GST charged.IAF option: Rs 4,000View certificationPRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS
ISO 15378:2017 Certification
Primary packaging materials for medicinal products. Typically about 5 working days after complete documents, payment and review.
What is ISO 15378:2017?
ISO 15378 applies ISO 9001 together with GMP principles to makers of primary packaging for medicines, such as bottles, blisters, foils, closures and tubes. Because this packaging touches the product, the standard stresses contamination control and traceability.
Who needs it?
- Pharma bottle, vial and closure makers
- Blister foil and laminate printers
- Tube and container manufacturers
- Packaging suppliers to pharma companies
Review the ISO 15378:2017 preparation checklist
What it can do for your business
- Meets pharma customer audit expectations
- Lower risk of contamination and print mix-ups
- Stronger batch traceability
- One system covering quality and GMP
FROM APPLICATION TO DECISION
How it works
01
Define scope and buyer needs
Identify activities, sites, the standard and edition, and any buyer or tender accreditation requirement.
02
Confirm the certification route
Check the issuing body, accreditation scope, assessment arrangements and total fees in writing before payment.
03
Prepare documents and evidence
Submit initial business documents and the records needed to demonstrate how your management system operates.
04
Complete review and assessment
The applicable review or audit may require additional evidence and corrective action. Timing depends on scope and readiness.
05
Decision and ongoing review
Issuance depends on successful review, not payment alone. Check the issued scope and arrange applicable surveillance and renewal.
STARTING YOUR APPLICATION
Initial business documents
These establish who is applying and the proposed business scope. They are the starting point; the service-specific review or assessment can require additional operational evidence.
Business registration
Udyam, incorporation certificate or shop licence.
Letterhead or visiting card
Your business name and contact details.
One business invoice
A recent sales or purchase invoice.
Your business scope
What you do, in one or two clear lines.
Prepare for ISO 15378:2017
Use these primary packaging materials for medicinal products checks to organise your preparation. For each item, identify the responsible person, the procedure used and a recent record showing what happens in practice.
- ISO 9001 quality system with GMP additions
- Risk management for contamination and mix-ups
- Controlled and clean production areas
- Batch records and traceability
- Validation of processes and change control
Make your evidence match your scope
- Describe the actual activities and locations to be reviewed, including outsourced work and responsibilities retained by your business.
- Choose current examples from your own operation. Record the date, responsible person and outcome so the reviewer can connect the evidence to your stated scope.
- Identify missing records or unfinished actions before assessment. A policy or blank template alone does not show how a process operates.
- Ask which records apply to your selected service and scope. This preparation checklist is not an exhaustive assessment or a promise of certification.
BEFORE YOU COMMIT
Confirm these details in writing before payment
Use the published price alongside the agreed scope and service terms when deciding whether the offering meets your requirement.
- Scope and deliverable: the applicable standard or scheme, edition, activities, sites and exclusions, and exactly what document or support the service provides.
- Issuing or assessment body: its name and role. If accredited certification is required, confirm the accreditation body and that the relevant standard and scope are covered.
- Buyer acceptance: share the actual tender or customer clause and confirm that the proposed route meets it. A certificate title alone does not establish acceptance.
- Assessment arrangements: required documents, audit or review stages, remote or on-site work, travel, readiness requirements and expected timing.
- Fees and exclusions: the selected service price, what is included, and any separate implementation, testing, site visit, travel or statutory registration costs.
- Ongoing obligations: applicable surveillance, renewal or reassessment, their fees, and how changes to your activities or locations should be reported.
Certification and accreditation have different roles. See ISO's guidance on choosing a certification body.
ICS✓
CERTIFICATE OF REGISTRATIONNon IAF Certification
ILLUSTRATIVE LAYOUT
ILLUSTRATIVE LAYOUT
Good systems.
Great possibilities.
Great possibilities.
This is to certify that the management system of
YOUR BUSINESS NAMEhas been assessed against the requirements of
ISO 15378:2017
PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTSCertificate numberSAMPLE-XXXXXNon IAF Certification
SAMPLE
Authorized
signatory
signatory
SAMPLE · NOT A VALID CERTIFICATE
A credential. Not a question mark.Independently checkable, right here.
A VERIFIABLE RECORD
More than a piece of paper.
The sample shows the layout. Issued records include your company, certified scope, applicable standard, dates and status. Specialist schemes follow their own issuer requirements.
Verify a certificateQuestions about ISO 15378:2017
01Is it only for pharmaceutical packaging?+
Yes. It is written for primary packaging materials that come into direct contact with medicinal products.
02Do we also need ISO 9001?+
ISO 15378 contains the ISO 9001 requirements, so a separate certificate is optional.
03What do pharma customers check?+
Line clearance, cleanliness, batch records, print control and change control.
A stronger system, together.
Explore related standards for your business.
GMP
GMP
Good manufacturing practice
Rs 6,000 Rs 9,000
Non IAF CertificationFinal price. No GST charged.View certification13485
ISO 13485:2016
Quality management system for medical devices
Rs 9,000 Rs 15,000
Non IAF CertificationFinal price. No GST charged.IAF option: Rs 26,500View certificationA SMALL STEP. A STRONGER BUSINESS.
Start your applicationReady to make it official?
ISO 9001: Non IAF Certification from Rs 2,500 · IAF Certification from Rs 4,000.
Non IAF Certification & IAF Certification · No GST chargedLET’S TALK ABOUT YOUR BUSINESSQuestions before
Questions before
you start?
Tell us what you need. We’ll help you understand scope, documents and the certification process.
A REAL PERSON. A CLEAR ANSWER.
Let’s get you certified.
Leave your details. We’ll help with the rest.