Autofits Quality Certificates: ISO, DMF, BSE/TSE and Material Declarations
Autofits Packaging Pvt. Ltd. is certified to ISO 9001:2015 (21.GGCS.IN.091174), ISO 14001:2015 (21.GGCS.IN.140169) and ISO 15378:2017 (21.GGCS.IN.151175), holds Drug Master File DMF 18100 and a CFDA registration, and supplies seals that are BSE/TSE-free to EMEA/410/01 rev. 3 with heavy metals held to a maximum of 100 ppm total. This page lists every certificate, registration and material declaration a buyer needs to open a supplier qualification file, with the reference to record for each. Certificate copies are supplied on request.
Key takeaways
- Three ISO certificates: ISO 9001:2015, ISO 14001:2015 and ISO 15378:2017, each with its certificate number below.
- Drug Master File: DMF 18100.
- CFDA registration for the China market is held; the registration is confirmed on the copy supplied.
- BSE/TSE-free to EMEA/410/01 rev. 3.
- Heavy metals: chromium VI, cadmium, mercury and lead, maximum 100 ppm total (EN 602, EC 94/62).
- AQL: critical nil, major not more than 2.5%, minor not more than 4%, tailorable.
- Copies of certificates and declarations are supplied on request, not published as downloads.
Certificates and registrations
Record these references in the supplier file; each certificate copy shows its scope and validity dates.
| Certificate or registration | Standard or scope | Reference to record |
|---|---|---|
| ISO 9001:2015 | Quality management system | 21.GGCS.IN.091174 |
| ISO 14001:2015 | Environmental management system | 21.GGCS.IN.140169 |
| ISO 15378:2017 | Primary packaging materials for medicinal products, with GMP requirements | 21.GGCS.IN.151175 |
| Drug Master File | Packaging component file for reference in customer submissions | DMF 18100 |
| CFDA registration | Registration for the China market | Shown on the copy supplied |
ISO 15378 is the certificate written for pharmaceutical primary packaging: it applies ISO 9001 requirements with GMP added for packaging that contacts a medicine; the standard is explained on the ISO 15378 page, and the practical difference between the two ISO certificates is set out in ISO 9001 vs ISO 15378. How a packaging DMF is referenced in a filing is covered under Type III Drug Master Files.
Material declarations and conformance statements
Beyond the certificates, a qualification file records what each material in the seal conforms to. These statements come from the Autofits product dossier and are supplied as declarations on request.
| Declaration | What it states | Applies to |
|---|---|---|
| BSE/TSE | Free of risk from animal spongiform encephalopathy agents, per EMEA/410/01 rev. 3 | Seal components; the product dossier makes the statement for the polypropylene grade |
| Heavy metals | Chromium VI, cadmium, mercury and lead, maximum 100 ppm total, per EN 602 and EC 94/62 | All seal components |
| REACH and RoHS | Compliant | Aluminium |
| Aluminium alloy | AA8011 conforming to EN 15088:2005, EN 10204 3.1 certification, tested to BS EN 485-2:2008 | Aluminium shell |
| Lacquer | Epoxy lacquer conforming to 21 CFR 175.300 | Aluminium coating |
| Polypropylene | IS 10910 and IS 10909, FDA 21 CFR 177.1520 (olefin polymers), EC 1895/2005 | Discs and buttons |
| Bisphenol derivatives | BADGE, NOGE and BFDGE not used | Polypropylene components |
The BSE/TSE statement is usually filed for each primary packaging component, seals included. What it covers, and why packaging risk sits in processing aids rather than in the metal or polymer, is explained under BSE/TSE compliance.
Inspection and acceptance limits
Certificates describe the system; the acceptance limits describe what a delivered lot is held to.
| Control | Limit or method |
|---|---|
| In-line inspection | 100% high-speed camera inspection |
| AQL, critical defects | Nil |
| AQL, major defects | Not more than 2.5% |
| AQL, minor defects | Not more than 4% |
| Tailoring | AQL can be tailored by agreement with the customer |
| Assembly environment | ISO Class 8 cleanroom for Ready-to-Use seals |
| Cleaning | Fully automated washing |
The plant behind these controls, at E-13/7/4, MIDC, Malegaon, Sinnar, Nashik, is described on the factory page, and the full quality system narrative is on the quality page.
How to check a certificate copy
Four checks turn a certificate copy into evidence you can rely on in an audit.
- Legal entity and address. The certificate should name Autofits Packaging Pvt. Ltd. and the Nashik site where the seals are made.
- Scope. The scope statement should cover the manufacture of the products you buy, such as aluminium and aluminium-plastic seals and caps.
- Validity. Record the issue and expiry dates shown on the copy, and diarise the renewal.
- Issuing body. Check the certificate number against the certification body’s own register, where it publishes one.
Record each reference against the part numbers you buy, so that a change in certification status can be traced to affected products. The batch records that link a delivered seal back to production are described in seal batch traceability.
What to send when requesting copies
State which documents you need and for which products, so the right set comes back together.
- Your company name and the site the seals are for
- Products and sizes being qualified
- Certificates required: ISO 9001, ISO 14001, ISO 15378
- Declarations required: BSE/TSE, heavy metals, REACH and RoHS, material conformance
- Whether you need a DMF reference for a regulatory submission, and for which market
- Your own questionnaire or declaration template, if you use one
Contact Autofits with the list above. The standards the range is built to, with what each requires, are gathered in the regulatory compliance pack.
Frequently asked questions
How do I get a copy of the Autofits ISO 9001:2015 certificate?
Certificate copies are supplied on request rather than published as downloads. Ask for the ISO 9001:2015 certificate, number 21.GGCS.IN.091174, together with any other certificates or declarations your qualification file needs, and name the products you are qualifying.
Which documents go into a supplier file for vial seals?
A typical file holds the ISO 9001, ISO 14001 and ISO 15378 certificate copies, the Drug Master File reference where a submission needs it, and declarations for BSE/TSE, heavy metals, REACH and RoHS and material conformance. It also records the AQL agreed for incoming lots. Each reference is filed against the part numbers bought.
What is a TSE/BSE declaration for packaging materials?
It is a supplier’s written statement that a component carries no risk of transmitting animal spongiform encephalopathy agents, usually because no materials of animal origin are used in it or in its processing. Pharmaceutical manufacturers file it for each primary packaging component, including vial seals and stoppers.
What heavy-metal limit do Autofits seals meet?
The combined content of chromium VI, cadmium, mercury and lead is held to a maximum of 100 ppm total, in line with EN 602 and EC 94/62. The declaration is supplied on request with the other material statements.
How do I check that a certificate copy is valid?
Confirm that it names Autofits Packaging Pvt. Ltd. and the Nashik site, that its scope covers the seals and caps you buy, and that the issue and expiry dates are current. Then check the certificate number, such as 21.GGCS.IN.151175 for ISO 15378:2017, against the issuing body’s register where one is published.
Related reading
- Regulatory compliance pack
- Quality systems and certifications
- ISO 15378 explained
- BSE/TSE compliance for packaging
- Type III Drug Master Files
Sources
- Autofits certifications as listed on the Autofits quality page and in the FlipTop Seals dossier
- ISO: ISO 15378:2017, Primary packaging materials for medicinal products, GMP requirements (https://www.iso.org/standard/70729.html)
- ISO: ISO 9001:2015, Quality management systems, Requirements (https://www.iso.org/standard/62085.html)
- EMA: Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products, EMA/410/01 rev. 3 (https://www.ema.europa.eu/en/minimising-risk-transmitting-animal-spongiform-encephalopathy-agents-human-veterinary-medicinal-products-scientific-guideline)
- U.S. FDA: Drug Master Files (DMFs) (https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs)
*Last updated: 2026-09-15. Certificate copies and declarations are supplied on request; validity dates are those shown on the copies. This page is general information, not regulatory advice for a specific submission.*
