Regulatory Affairs

Due to their vital role in providing safe and effective products to the healthcare industry, pharmaceutical businesses are subject to ever-stricter regulatory standards. To lessen the burden of regulation and make sure that customers can comply with all requirements effectively and professionally, SNG Pharma offers paperwork and expert support.

Pharmaceutical rules all throughout the world protect the calibre of licenced medications. These laws also cover packaging, which has a direct impact on important product characteristics. SNG Pharma makes and controls its primary packaging in accordance with all pertinent international standards and employs a strict selection procedure for all of its suppliers, vetting their credentials and performance.

Products from SNG Pharma are made at establishments that adhere to a quality management system that is certified in accordance with ISO 15378 standards and, as a result, where GMP standards unique to pharmaceutical primary packaging are constantly followed.

We work within the following relevant rules for ordinary glass vials:

International Standards

ISO 15378 Standard
International Standard for Phytosanitary Measures 15 (ISPM 15) on wood materials

Pharmacopoeial Guidance

European Pharmacopeia: Chapter 3.2.1
United States Pharmacopeia: USP <660>
Japanese Pharmacopeia: Chapter 7.01 method 1
Chinese Pharmacopeia: YBB

EU Regulations And Directive

EU Directive 94/62/EC on “Packaging and packaging waste”
EU Regulation 1907/2006/EC (REACH Regulation) on “Registration, Evaluation, Authorisation and Restriction of Chemicals”
EU Regulation 1935/2004/EC on “materials and articles intended to come into contact with food”
EU Directive 84/500/EC and its amendments on “ceramic articles intended to come into contact with foodstuffs”
EU Note for guidance EMA/410/01 on “minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products”

REGISTRATION OF PRODUCTS

SNG Pharma has registered Drug Master Files (DMF) for its Glass Primary Packaging with the relevant regulatory bodies at the National Medical Products Administration (NMPA, previously the Chinese FDA), Health Canada, and the United States Food and Drug Administration (US FDA).

All customers who request letters of authorization (LOA) will receive them without charge and in a timely manner.

OUR EXPERIENCE IN REGULATION
The knowledgeable staff at SNG Pharma provides top-notch regulatory support and keeps a vigilant eye on compliance issues. These experts have a wealth of knowledge and experience, and they actively participate in important committees and associations like FEVE (the European Federation of Glass Packaging Makers), PDA (the Parenteral Drug Association), and AFNOR (Association Française de Normalisation/French Standardisation Association), which enables them to provide unmatched support.

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Certification

cGMP Plant as per ISO 15378 with DMF from USFDA and Health Canada

Company Success

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About US

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