cGMP Regulations for Marketing Authorization. Pharmaceutical Packing Materials in USA

      Аннотация: While in storage, throughout transportation, during exhibition, and up until the product is consumed, packaging should offer protection, identification, information, convenience, and compliance for the product. When choosing a packing material, it is important to have a complete understanding of the product, the market, the distribution system, and other facilities that are available. Concerning issues such child safety, proper dosing, patient traceability, product tampering, and diversion of pharmaceuticals should be taken into consideration while designing pharmaceutical packaging. Hospitals, clinics, assisted living homes, doctor's offices, and individual consumers now feel a greater sense of urgency due to serious added concerns about drug counterfeiting and concerns about terrorism.

Ключевые слова: CGMP, Market Authorization, regulatory guidelines