GMP, GLP & GDP Questions And Answers 2023

GMP, GLP & GDP Questions And Answers 2023 What is the role of OA in a GLP study? - ANS-Make sure documentation is done correctly. What is the role of QA in a GMP environment? - ANS-Make sure documentation is done correctly (batch records, SOPs) Work with CAPA What is the essence of GDP? - ANS-If it's not documented, it didn't happen. What is the purpose of GDP? - ANS-To prove the manufacturer did what it said it would do. To comply with FDA regulations. To discover the root cause of any problems For CAPA What are the two categories of documents? - ANS-Documents: (To be read and studied only) For information and training to ensure quality and safety eg. SOPs, WIs Records: (To be completed) Filled out contemporaneously to provide evidence that something occurred or of an idea or finding and identify the date it happened and the person responsible. What are the 6 general requirements of GDP documents - ANS-Clearly Written (language, traceability, accuracy) Written in indelible ink Legible handwriting review and approval signatures Signed delegation of responsibility Page numbering (all in page x of y format) What is an SOP? - ANS-Detailed instructions for making a product. Continues...