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

A pharmaceutical manufacturer installs a new mixing vessel intended for use in tablet production. Production staff want to begin manufacturing immediately, but the Quality Manager states that the equipment cannot be used until qualification activities are completed. Which sequence of qualification steps must be performed before the equipment can be released for routine GMP manufacturing?

A public sector wholesaler stores medicines in a warehouse with fluctuating temperatures and high humidity.

A wholesaler receives a new batch of vaccines. Before distribution, which of the following is required?

A pharmaceutical company contracts a third-party manufacturer to produce a sterile injectable product. After manufacturing, the finished product is delivered to the company for final release and distribution. Which statement best describes the responsibility for product quality and regulatory compliance?

A GMP inspector requests the SOP for a line-clearance cleaning procedure currently being performed. The staff are unable to provide any controlled version of the document. What does the inspector expect to see in a “controlled document” as opposed to a document not controlled?             

Explain how ICH Q8, Q9, and Q10 work together to ensure product quality and patient safety.     

During final QC of a tablet batch, a minor labelling discrepancy is detected. Which statement best describes the responsibilities of the QP and RP?

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

During a logbook review, a QA auditor notices entries are missing dates, operator initials, and chronological order is not maintained. Which GMP principle is violated?