Annual Product Quality review in pharmaceutical industry I APQR in pharmaceutical industry ----------------------------------------------------------------------------------------------- Go to below playlists and search for a topic you want: 1. QMS - Quality Management System in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNqnXftgTHiLdxM154CmoRsR 2. QA- Quality assurance in Pharmaceutical industry. : https://www.youtube.com/playlist?list=PLWElJz3ahCNoFfgX3bYjXwSPtO8KyK1gP 3. QC - Quality Control in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNpvL3dRLtGjc_BRuRkx0CVT 4. OSD - Tablet Manufacturing in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNoSYaSlSrkdbk6j-bHTy72T 5. Injectable processing - Injectable processing or Sterile dosage formulation : https://www.youtube.com/playlist?list=PLWElJz3ahCNoqGqSfdeJlBgpKfuUlQF_f ----------------------------------------------------------------------------------------------- Questions covered: Q. Q. What is APQR, and why is it important in the pharmaceutical industry? Q. Which points are commonly included in the APQR summary report ? Q. Who shall prepare APQR ? Q. How do you handle deviations and out-of-specification results in APQR? Q. Why stability studies are important for APQR ? Q.: What is importance of trending analysis in APQR ? Q. How do you ensure that APQR recommendations are effectively implemented? Q. What software tools or systems we can use for APQR data management and analysis ? Q. What should be the frequency for preparation of APQR ? Q. What if no batches are manufactured in the review period of APQR ? Q. For how long APQR shall be retained ? Q. What is CpK value and what is acceptance criteria for CpK value? Q. What are EMA’s requirements for batch consideration for APQR ? Q. Explain the key components of an APQR report ? Q. Whether we can group APQR for different product type e.g. solid dosage forms, liquid dosage forms, sterile products etc ? Q. Which findings from APQR shall be reported to FDA ? Q. Which guidelines are referred for APQR in pharmaceutical industry ? ---------------------------------------------------------------------------------------------- Keywords to find this video: annual product quality review,product quality review,annual product review,annual product quality review in pharma,pharmaceutical industry,product quality review ich q7,annual product review slideshare,annual product quality review sop,annual product review sop,annual product quality review fda guidance,product quality review eudralex,product quality review sop,annual product review fda guidance,quality risk management in pharmaceutical industry ----------------------------------------------------------------------------------------------- Copyright disclaimer: “Any illegal reproduction of this content will result in immediate legal action.”

• published: 06 Oct 2023
• views: 8731