Medical Device GMP Consulting Recent reviews and key points of review GMP review trends: In the recent GMP review, the parts that are considered to be the main contents of the review without distinction of review…blog.naver.comMedical device GMP review preparation and response, and supplementary case medical device curriculum, there is a part about GMP field review preparation and response, so I extracted and organized it… blog.naver.comIn some cases, when the answers are obtained and supplemented (or before), the questions you uploaded are neatly deleted, but it’s a shame that I can’t look at them anymore because the answers along with the questions disappeared. In particular, there seem to be more deletion of questions related to the supplementation of the GMP review of medical devices than other questions. Maybe it’s because you think there is something confidential about the company’s confidentiality…1) Matters to be noted during the recent GMP review – Whether usability evaluation is carried out or not – Whether cybersecurity testing and risk management are applied – Whether computer software validation is performed and applied – Whether UDI procedures are established – Whether quality documents and records that do not correspond to validity period are established – Whether or not the product is handled and stored (how to store) contents – Complementation with manufacturing process procedures and contents of work standards – Software maintenance history (version, etc.) 2) Matters to be noted during the initial review – QMS construction: Appropriateness of quality manuals, procedures, standards and related forms – Inspection and appropriate verification of equipment – Accurate design and development history of products – Supplier and purchase management information – Training and completion of quality managers – Internal review and management review history – Consistency to related forms such as product standards and production diaries – Appropriateness of relevant forms to track process and medical device information – Whether risk management is performed – Consideration of appropriate procedures and processes according to risk level and level – Material to verify safety and validity of products – Material to be able to verify safety and effectiveness of products – Report of medical device production and related inspection history – Whether side effects such as abnormal case are reported or not – Internal review, business review and follow-up measures – Inspection and verification of process and measuring equipment – Record level appropriate for quality system – Whether processes are performed according to update and cycle of records – Considering product nonconformity, customer complaints, and feedback level – Conformity of current quality system due to changes in medical device and process – Gathering information on post-market (after release of medical device) and applying QMS, etc. – Update and application in accordance with the revision of the law 2. This is an excerpt and summary of the questions answered in the last 6 months at the RA specialist Naver Cafe (https://cafe.naver.com/raspecialist) , a group of working-level medical device RA personnel. From the purpose of posting questions on the cafe, it is more difficult to grasp or resolve the meaning of the supplementary content than the frequency of supplementary content. The answers may be only opinions or advice from practitioners, but may not be the correct answer.I’ve summarized the supplements of the recent GMP review of medical devices. Please refer to it as an example because the solution depending on the supplementation may vary from company to company. 1. Opinion of Consulting Companies Below is the data posted by Medi & Works, a medical device consulting institution.
