Documented evidence that, for example, the premises, supporting systems, utilities, equipment and processes have been designed in accordance with the requirements of good manufacturing practices (GMP). 设计确认 书面证据,例如,设施、支持系统、公用系统、设备和工艺是根据良好生产规范(GMP)的要求设计的。
2.10. The selection of an appropriate dosageform for clinical trials is important. While it is accepted that the dosageform may be very different from the anticipated final formulation (e.g. acapsule instead of a tablet) in early trials, in the pivotal Phase III studies,it should be similar...
Has the manufacture of this type of dosage form been inspected? (yes/no)3.3 Do the facilities and operations conformto GMP as recommended by the World Health Organization?15(yes/no/not applicable)144. Does the information submitted by the a 8、pplicant satisfy the certifying authority on all...
the dosage form is produced? (yes/no/not applicable) If not or not applicable, proceed to question 4. 3.1. Periodicity of routine inspections (years): 3.2. Has the manufacture of this type of dosage form been inspected? (yes/no) 3.3 Do the facilities and operations conform to GMP as re...
1.1 Thisdocument concerns water for pharmaceutical use (WPU) produced, stored anddistributed in bulk form. It intends to provide informationabout different specifications for WPU; guidance on GMP regarding the qualitymanagement of water systems; water treatment (production) systems; waterstorage and dist...
良好生产规范(GMP) 质量保证的一部分,可确保始终如一地生产和控制药品,达到适合其预期用途的质量标准,并符合上市许可要求。 in-process control (IPC). Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its specificati...
themanufacturingplantinwhichthedosageformisproduced?(yes/no/not46 applicable) 14 47 Ifnotornotapplicable,proceedtoquestion4.48 3.1.Periodicityofroutineinspections(years):49 3.2.Hasthemanufactureofthistypeofdosageformbeeninspected?50 (yes/no)51 3.3DothefacilitiesandoperationsconformtoGMPasrecommended52 ...
1.1. In recent years, the number ofobservations made regarding the integrity of data, documentation and recordmanagement practices during inspections of good manufacturing practice (GMP) (2),good clinical practice (GCP), good laboratory practice (GLP) and Good Trade andDistribution Practices (GTDP)...
Please refer to the guidelines for full instructions on how to complete this form and information on the implementation of the Scheme.The forms are suitable for generation by computer. They should always be submitted as hard copy, with responses printed in type rather than handwritten.Additional ...
Has the manufacture of this type of dosage form been inspected? (yes/no) 3.3 Do the facilities and operations conform to GMP as recommended by the World Health Organization?15 (yes/no/not applicable)14 4. Does the information submitted by the applicant satisfy the certifying authority on all...