General guidance on hold time studies

2024-07-06T08:33:09+00:00

Introduction and background Manufacturers should ensure that the products that they manufacture are safe, effective and of the quality required for their intended use. Systems should be in place to ensure that pharmaceutical products are produced according to validated processes and to defined procedures. Manufacturing processes should be shown to be capable of consistently manufacturing pharmaceutical products that are of the required quality and that comply with their specifications. Good manufacturing practices (GMP) require that arrangements should be made to ensure that the dispensed raw materials and packaging materials, intermediate products, bulk and finished products are stored under appropriate [...]