Iq oq pq - Study guides, Class notes & Summaries

IQ, OQ, PQ, PROCESS VALIDATION, PAT EXAM QUESTIONS AND ANSWERS...

Introduction to qualification Qualification is part of validation, but the individual qualification steps do not in themselves constitute process validation. Validation is the entire process by which a product is obtained from a manufacturer or distributor and is examined and tested before it is formally approved for routine use. A qualification exercise generally consists of four sequential phases: design qualification (DQ), IQ, OQ, and PQ. a. DQ: The purpose of DQ is to ensure that ...

. Introduction This Technical Supplement has been written to amplify the recommendations given in section 4.7 of WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products. 4 It covers the three stages of qualification needed before the release of a temperature-controlled storage area for routine use: installation qualification (IQ), operational qualification (OQ) and performance qualif...

Blood Bank Rotation Exam Questions and Answers Latest Update Graded A+ Blood is stored at what temperature? - Answers 1 - 6 C Reagents are stored at what temperature? - Answers 2 - 6 C Platelets are stored at what temperature? - Answers 20-24 C (Room Temp) with continuous agitation -If temp is not monitored automatically, the temp MUST be checked every 4 hours What is the temperature of the freezer? - Answers -18 C or colder What is the temperature range for incubator/heat blocks? - Answe...