The scope of the APQ Guide Series is aligned with the ICH Q10 PQS model [1] (as explained further in Section 2.1). Therefore, the practices described in the APQ Guides apply to all aspects of the PQS relevant to the manufacturing, packaging, testing, or holding of biological, chemical, advanced therapy medicinal products, combination medicinal drug products, and their associated active pharmaceutical ingredients. The principles described may also apply to medical devices, over the counter products, personal care, and cosmetics products and may be beneficially applied
throughout the product lifecycle from research and development, technology transfer, commercialization, and discontinuation.