During the analytical laboratory inspection, an HPLC used for API assay lacks recent calibration and performance verification records. What is the expected corrective action?

During stability studies or product storage, pharmaceutical manufacturers use Mean Kinetic Temperature (MKT) to evaluate the effect of temperature fluctuations on product stability. Which of the following statements best describes the purpose of MKT?

A PIC/S inspector observes that electronic chromatograms in the laboratory LIMS system can be modified without audit trails. Which of the below statement is correct?

Fill in the blanks using the prompts. (4×1 point) 1) 리사: 이거 누구 가방이에요? 샌디: 44. [answer44]예요. 이건 누구 가방이에요?              (It’s mine) 리사: 45. [answer45]이에요.             (마크’s bag)   2) 오늘 46. [answer46]?              (what are you doing?)   3) 이름이 47. [answer47]?                       (what is…?)    

Which main steps of Quality Risk Management (QRM) would you follow to assess the risk of changing the production equipment for solid oral dosage forms in accordance with the relevant ICH guideline?           

Define Quality by Design (QbD) and its role in pharmaceutical development. 

Which of the following statements about Quality Risk Management (QRM) is correct?

During product formulation development, the team identifies that a critical excipient may degrade under high humidity. According to ICH Q8 and Q9 guidelines, what should be the next step?

During a PIC/S analytical laboratory inspection, auditors notice analysts performing a test procedure from memory, rather than following the approved SOP. What is the correct regulatory expectation?

A manager has asked that newly drafted SOPs, which contain comprehensive technical paragraphs, be rewritten. Why is this revision necessary?