| Answer |
The Polish GIF (Główny Inspektorat Farmaceutyczny - Chief Pharmaceutical Inspectorate), which supervises (inspects) manufacturers of medicinal products and active pharmaceutical ingredients, does not issue GMP certificates for excipient manufacturers. Manufacturers of excipients are not subject to periodic inspection or other control for monitoring the manufacturing process by Polish GIF. We have global procedures and quality systems regulating manufacturing and product control conditions that have been developed based on the good manufacturing practices described in IPEC PQG GMP and ICH Q7, as they apply to the product. |
