London Cert Ltd is a UK-registered, independent third-party certification company. Our ISO 15378 certificates are built for GeM, CPPP, Indian government tenders, and international client requirements in 30+ countries. 3–4 week process. Fixed price. 100% approval rate.
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ISO 15378 — "Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001, with reference to Good Manufacturing Practice (GMP)" — is the international standard for manufacturers of packaging that comes into direct contact with medicines: vials, bottles, blister packs, closures, and similar materials in glass, plastic, rubber, and aluminium. London Cert Ltd conducts the audit directly, and your certificate is issued with genuine IAF accreditation through our accredited certification partner.
ISO 15378 takes the full ISO 9001 quality management structure and layers in GMP-specific requirements unique to pharmaceutical packaging: contamination control, cleanroom and environmental monitoring where relevant, change control for materials that could affect drug stability or safety, and full traceability from raw material through to the finished packaging component reaching a pharmaceutical manufacturer's line. Because primary packaging is in direct contact with the medicinal product itself, even small defects — a contaminated vial, an ill-fitting closure — can compromise drug safety, sterility, or shelf life.
The standard is recognised across the world's major pharmaceutical regulatory regimes — the US Code of Federal Regulations, European directives, and Indian regulations all reference GMP principles that ISO 15378 operationalises specifically for packaging manufacturers.
💡 ISO 15378 doesn't replace ISO 9001 — it is ISO 9001 with pharmaceutical-packaging-specific GMP requirements built in. If you already hold ISO 9001, transitioning to ISO 15378 leverages much of your existing documentation structure.
India's pharmaceutical manufacturing sector is going through its most significant compliance overhaul in decades. Revised Schedule M, notified in January 2024 and binding on all Indian drug manufacturers as of 2026 (large manufacturers were required to comply by mid-2024; MSME manufacturers had an extended deadline to 31 December 2025), brings Indian GMP requirements substantially closer to WHO-GMP, EU-GMP, and US FDA expectations. It introduces structured Pharmaceutical Quality Systems (PQS), Product Quality Review (PQR), Quality Risk Management (QRM), and — critically for packaging suppliers — rigorous, risk-based vendor qualification of raw material and packaging suppliers.
This is where ISO 15378 becomes directly relevant to your business even if you never manufacture the drug itself: pharmaceutical manufacturers under Revised Schedule M scrutiny now need to demonstrate robust auditing of their packaging vendors as part of their own compliance. An ISO 15378-certified packaging supplier gives pharma manufacturers exactly the internationally recognised, audited evidence their own Revised Schedule M vendor qualification file needs — turning your certification into a genuine sales advantage, not just a compliance cost. With only around 2,000 of India's roughly 10,500 pharmaceutical manufacturing units currently holding WHO-GMP certification, and CDSCO conducting monthly risk-based inspections, demand for qualified, certified packaging suppliers is intensifying.
Critical: Only certificates issued by IAF-accredited bodies are genuinely valid for GeM, CPPP, and international procurement. India has thousands of fraudulent ISO bodies selling unaccredited certificates that are regularly rejected by compliance teams. London Cert is IAF-accredited.
Manufacturers of plastic containers and bottles for pharmaceutical use
Manufacturers of rubber closures and stoppers
Manufacturers of aluminium caps, seals, and foils
Blister pack and foil manufacturers
Any supplier whose packaging materials come into direct contact with medicinal products, including for medical device applications
⚠️ Only a certificate carrying genuine IAF (International Accreditation Forum) accreditation is internationally recognised — and only genuine certificates will withstand scrutiny during a pharmaceutical customer's Revised Schedule M vendor audit. London Cert Ltd conducts your full audit directly — we are not a paperwork-only reseller — and your certificate is issued with IAF accreditation through our accredited certification partner, verifiable at verify.londoncert.co.uk.
Free consultation. Fixed-price quote in 24 hours. 3–4 weeks to certificate.
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GeM, CPPP, UPEIDA, PSUs — a large share of Indian government procurement lists ISO 15378 Certification as an eligibility criterion. We build your certificate and documentation around what your specific tender requires.
Tata, L&T, Reliance, Infosys, Wipro — major corporates require ISO 15378 Certification from all tier-1 and tier-2 vendors. It's the baseline quality signal that corporate procurement teams look for first.
Buyers in USA, UAE, Europe, and UK increasingly require ISO 15378 Certification before signing supply contracts. We help you meet the documentation standards international buyers expect.
ISO 15378 Certification forces systematic process documentation, internal audits, and management reviews that produce real operational improvements — reduced defects, faster delivery, lower costs.
Many MSME schemes, state industrial park registrations, and working capital loan applications require ISO 15378 Certification. Certification unlocks government benefits your business is already entitled to.
In competitive pitches, the certified vendor wins more often. Clients choose certified vendors — especially in manufacturing, IT, construction, and food processing — for perceived reliability and quality commitment.
Real, verified reviews from businesses we've certified across industries and countries.
“Getting ISO 15378 Certification certified with London Cert was far smoother than our previous agent. Documentation, audit scheduling, everything was handled — and the certificate held up fine on our GeM tender review.”
“We needed ISO 15378 Certification quickly for a client contract. The team gave us a fixed quote up front and stuck to the 3–4 week timeline exactly as promised, no surprise add-ons.”
“Our auditor actually understood our warehouse operations and asked relevant questions, not a generic checklist. ISO 15378 Certification certification felt like a real assessment, not a formality.”
“Buyers overseas verified our ISO 15378 Certification certificate directly on London Cert's portal before signing off — that verifiability made a real difference in closing an export contract.”
“As a small business, we were worried about cost and complexity. London Cert scoped the ISO 15378 Certification audit to our actual size — no unnecessary paperwork, and it unlocked an MSME scheme we didn't know we qualified for.”
“Renewal for our ISO 15378 Certification certificate was straightforward — the surveillance audit was scheduled well in advance and the auditor's feedback actually helped us tighten our documentation.”
India has a serious fake ISO body problem. Here's exactly why London Cert certificates are genuine, accepted globally, and legally valid.
What each clause requires, and the documents it generates.
A clear, predictable process. From first call to certificate in hand in 3–4 weeks. No hidden steps, no surprises.
Call, WhatsApp, or fill the form. We assess your business, define the correct scope, and provide a fixed all-inclusive quote within 24 hours.
Day 1 — FreeWe prepare all required ISO 15378 documents, tailored to your actual business operations and sector.
Week 1–2Our certified auditors conduct Stage 1 (document review) and Stage 2 (implementation audit — remote or on-site). Non-conformities are closed immediately.
Week 2–3Your IAF-accredited certificate is issued with a unique verifiable ID. Hard copy delivered by courier. Online verification available instantly.
Week 3–4Your ISO 15378 certificate is valid for 3 years. To maintain validity:
London Cert manages your full surveillance and recertification schedule. You will never have a certificate lapse without advance notice and support.
Fixed-price, all-inclusive packages. No hidden fees. No surprise invoices. The price you're quoted is the price you pay.
Why we don't publish exact prices: ISO 15378 Certification certification cost depends on your specific company size, number of locations, number of employees, industry, and documentation complexity. A fixed published price would either overcharge small businesses or undercharge complex ones. Contact us for a personalised, binding quote within 24 hours — specific to your business.
More employees = more audit time. Audit duration is directly tied to your employee count and the scope of operations being certified.
Each additional location may require separate or extended audit time. Multi-site certifications are priced accordingly — contact us to discuss.
Simple service businesses have fewer process documents than complex manufacturing operations. Documentation scope directly affects cost.
If you already have some quality management processes documented, less preparation work is needed — which can reduce the overall cost.
Remote audits are available for all businesses and are typically more cost-effective. On-site audits are available for clients who need or prefer physical presence.
Most certification companies require you to hire a separate consultant to prepare documentation — and then pay the certification company for the audit on top. London Cert does both. This integrated approach saves time and significantly reduces total cost.
Why businesses in these sectors need ISO 15378 Certification, specifically.
Required by Tata, L&T, BHEL vendors. Needed for industrial tender pre-qualification. Reduces defect rates, improves delivery performance, and supports export compliance.
Required for government IT contracts (NIC, NSDL, state IT depts), international clients, and NASSCOM vendor registration. Often paired with ISO 27001 for data security.
Mandatory for CPWD, NHAI, Smart City, and all state PWD tenders. Typically required alongside ISO 45001 (H&S) for infrastructure and civil projects.
Required for hospital supply chains and government pharma tenders. Medical device manufacturers use ISO 13485, which extends ISO 15378 Certification's core principles for regulated devices.
Required for FSSAI-compliant export, hotel supply chains, and institutional food supply tenders. Often combined with ISO 22000 (Food Safety Management System).
Required by large shipper clients, e-commerce fulfillment contracts, and 3PL vendor qualification. Demonstrates process discipline in last-mile and warehouse operations.
Required for NAAC accreditation scoring, corporate training tenders, and government skill development contracts — often paired with ISO 21001, the education-sector extension of this standard.
Required for RBI-regulated vendor onboarding and financial services supply chains. Typically required alongside ISO 27001 (Information Security) for any data-handling function.
Required for marketplace vendor credibility, B2B supply agreements, and enterprise retail contracts. Demonstrates consistent quality across customer experience processes.
Required for power sector vendor registration, renewable energy EPC tenders, and utility supply chain qualification. Often combined with ISO 50001 (Energy Management).
Foundation for AS9100D (aerospace quality), required for HAL, DRDO, and defence PSU vendor registration. Many aerospace supply chains require ISO 15378 Certification as a minimum entry standard.
Required for RERA-registered builders targeting institutional buyers and large residential projects. Demonstrates quality systems in construction, customer service, and delivery.
The 13 most-asked questions about ISO 15378 Certification certification — straight, accurate answers.
ISO 15378 is the international standard for primary packaging materials for medicinal products, combining ISO 9001 quality management requirements with Good Manufacturing Practice (GMP) principles specific to pharmaceutical packaging — vials, bottles, blister packs, closures, and similar materials that come into direct contact with medicines. London Cert Ltd conducts the certification audit directly, and delivers your certificate with IAF accreditation through our accredited certification partner.
Our ISO 15378 Certification experts are available Mon–Sat, 9AM–7PM IST. Free consultation, no obligation.
Talk to an Expert →Free consultation. IAF-accredited certificate. Fixed price. 3–4 weeks. 100% approval rate.