media fill records, visual inspection records, process validation batch records, and cleaning validation records saved on his computer or through your document management system. When production employees reported an “error” in a record, your production m...
particulate control that incorporates product development,manufacturing controls, visual inspection techniques, particulate identification,investigation, and corrective actions designed to assess, correct, and preventthe risk of visible particulate contamination.2The guidance also clarifies that meeting an applicable...
一、Test(s) performed You should identify the tests performed. If the testing was conducted as recommended by a FDA guidance document or FDA-recognized consensus standard. we recommend that you state such in the test report summary. 说明已执行的测试是否是按照FDA指导文件或FDA认可的共识标准进行检测...
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data i...
For more information about handling failing, OOS, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance document Investigating Out-of-Specification(OOS) Test Results for Pharmaceutical Production ath...
For additional guidance on aseptic processing see FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing athttps://www.fda.gov/media/71026/download....
Several firms have asked FDA for specific guidance on what FDA expects firms to do to assure compliance with the requirements for process validation. This guideline discusses process validation elements and concepts that are considered by FDA as acceptable parts of a validation program. The constituen...
ForthePurposesofthisguidance,dataintegrityreferstothecompleteness, consistency,andaccuracyofdata,Complete,consistent,andaccuratedatashould beattributable,legible,contemporaneouslyrecorded,originaloratruecopy,and accurate(ALCOA).5 就本指南而言,数据完整性是指数据的完个性、一致性和准确性。完个、一臻和 ...
(e.g.,justificationforthemethodsusedtoperformthetesting,clinical/scientificengineeringbasisfortheacceptancecriteria,outlyingandanomalousresults).Notethatajustificationformethodsand/oracceptancecriteriaisgenerallynotneedediftheyweredirectlyobtainedfromaFDA-recognizedconsensusstandardorguidancedocument.Adiscussionofthetest...
FDA行业指南:注射产品可见颗粒的检查-202112草案(中英文对照版).pdf,FDA 行业指南:注射产品中可见颗粒的检查-2021 草案 Inspection of Injectable Products for Visible Particulates 注射产品中可见颗粒的检查 Guidance for Industry 行业指南 DRAFT GUIDANCE This gui