Pharmaceutical businesses face ever-stricter regulatory standards. Shree Naina Glass Inc. offers the documentation and expert support to lessen that burden.
Pharmaceutical regulations worldwide protect the quality of licensed medications, and that includes packaging, which has a direct impact on important product characteristics. Shree Naina Glass Inc. makes and controls its primary packaging in line with all relevant international standards, and applies a strict selection process for every supplier, vetting their credentials and performance.
Our products are made at facilities that operate under a quality management system certified to ISO 15378, so the GMP standards specific to pharmaceutical primary packaging are followed consistently.
Shree Naina Glass Inc. has registered Drug Master Files (DMF) for its glass primary packaging with the relevant regulatory bodies at the National Medical Products Administration (NMPA, China), Health Canada, and the United States Food and Drug Administration (USFDA).
Drug Master File on record.
Drug Master File on record.
Drug Master File on record.
Our knowledgeable regulatory staff keep a vigilant eye on compliance issues, and actively participate in industry committees and associations, including FEVE (European Federation of Glass Packaging Makers), PDA (Parenteral Drug Association) and AFNOR (Association Française de Normalisation).