GXP Inspection & Lab Accreditation
【Update Date:2018-10-18】unit:品質監督管理組
Q1: If a Western Pharmaceutical Manufacturer sets up additional storage sites outside the scope of premises approved in accordance with GMP, should it report to the competent authority for reference?
A: With regard to the principles applicable to the management of additional storage sites to be set up by a Western Pharmaceutical Manufacturer outside the scope of premises approved in accordance with the GMP, the FDA has provided relevant information through the official letter FDA Risk No. 1051101903 dated April 11, 2016, which states: “In order to make more robust the total supply chain management of medicinal products, and to ensure the manufacturing quality of medicinal products, if a pharmaceutical Manufacturer is to set up additional warehouses for storing raw materials, semi-finished products, or final products outside the originally approved scope of premises, GMP requirements shall be fulfilled, and management and inspections shall apply. GMP operations are allowed only after they are inspected and approved by the TFDA.
In addition, Article 27 of the Pharmaceutical Affairs Act stipulates that a Western Pharmaceutical Manufacturer that has a change in its scope of premises shall apply for altered registration with the local competent health authority.
Q2: Regarding technical documents relevant to the implementation of PIC/S GMP, what are the references available?
A: For the implementation of GMP as promoted by the TFDA, in addition to the announce the validation guidance and the production of the e-newspaper on GMP, GMP technical forums and GMP seminars have also been organized to foster exchange of opinions between indusries. For relevant documents, you may also refer to the regulations and inspection highlights released by the WHO, PIC/S, and the competent authorities of the Top 10 advanced countries, as well as the publications of the ISPE, PDA, and other organizations.
Q3: Is endotoxin testing considered essential at the end of shelf life to confirm parenterals to be pyrogen-free?
A: Endotoxin testing is not requested at the end of shelf life, taking into account the fact that it is not considered a stability-indicating parameter. The shelf-life specification should be completed with a footnote stating that endotoxins are not tested during stability studies.
Q4: Is sterility testing considered essential at the end of shelf life to confirm parenterals to be sterile?