Quality & Compliance.
Stericon is an ISO 13485 certified company by DNV GL Presafe, Norway.
Stericon’s Contact Lens Cleaning Solutions are CE certified by DNV GL Presafe, which certifies that the products comply with the applicable requirements of the European Medical Device Directive. The CE Certificate authorises the free movement/marketing of Stericon’s Contact Lens Cleaning Solutions in all European Union countries.
Stericon is also BRC (British Retail Consortium) Certified by SGS, UK. This certifies Stericon to supply to UK retail chains through a strategic manufacturing alliance with EM Pharma UK for supply to Tesco, Boots, etc.
The Stericon manufacturing facility in Bangalore has also been audited and approved by TESCO, UK, Morrisons and other UK retail chain stores.
Stericon is a member of SEDEX, UK (Supplier Ethical Data Exchange) and is committed to continuous improvement of its ethical performance. Stericon also undergoes yearly Social and Ethical audits by various international organisations
List of certifications, product registrations & audits.
Certifications
ISO 13485 & CE 2460 certification by DNV GL Presafe, Norway.
Manufacturing Certificate issued by The Drug Controller of Karnataka, INDIA for Eye / Ear and Nasal Drops.
Manufacturing Facility GMP Certificate issued by The Drug Controller of Karnataka, INDIA
WHO GMP certificate is issued by The Drug Controller of Karnataka, INDIA.
Free Sale Certificate issued by The Director General of Foreign Trade, Government of India for all products.
Company is certified for BRC (British Retail Consortium) Global Standard Audit for consumer products by SGS, UK for manufacture & supply of sterile contact lens cleaning solution
Product Registrations
The manufacturing facility is approved by NAFDAC – NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION CONTROL, AFRICA for supply of Pharmaceutical Eye & Ear Formulation to Nigeria.
Product registration of Aquasoft Astek MPS / Aquasoft Fresh MPS / Astek Hydro MPS / Aquasoft Fresh Refreshing Eye Drops/ Max optifresh bioplus by Jordan Food & Drugs Administration.
Product registration by Thai Food & Drugs Administration for C&C / Q-Eye MPS/ Aqua Fresh/ SOF Tear Eye Drops/ Aqua tear eye drops.
Registered with SEDEX (Supplier Ethical Data Exchange), UK.
Product registration by Indonesian Ministry of Health for a+ MPS/ a+ drops/ X2 Comfort MPS/ X2 contacts drops.
Product registration by Singapore HSA for contact lens cleaning solution and HA drops.
Fashion Care, Fashion care Premium. GP advance ultra-moist is registered in Kingdom of SAUDI ARABIA through SAUDI Food and Drug authority (SFDA) for Contact Lens Cleaning Solution in 2012.
ASTEK MPS Registered in Sri Lanka with Srilankan ministry of health.
AQUASOFT ASTEK-4 / AQUASOFT FRESH MPS/ AQUA PREMIUM/ AQUA ASTEK-4/ AQUA ASTEK FRESH/ Registered in Ministry of health, Morocco.
AQUASOFT ASTEK / ASTEK MPS / ASTEK DROPS Registered with Philippines FDA.
Multipurpose solution is registered in TGA Australia.
Aqua Boz is registered in MOH Bolivia.
Aqua soft Astek-4/ Aquasoft Fresh Drops is registered in MOH & Welfare of Taiwan.
Nosaline drops/ Spray are registered in MOH of OMAN.
Aquila Multipurpose contact lens solution is registered in MEDSAFE of New Zealand.
Audits
Ethical and Social Audit is conducted annually by External agencies.
An approved Tesco UK supplier. Undergoes regular Tesco Quality Audits.
Morrison UK audit completed as per the Global Non Food Manufacturing Standard.
Boots UK quality audit was conducted by auditors from Boots.