SAVA Healthcare Senior Executive QA Interview Questions and Answers

Change control is a process that ensures all changes to a system are documented, reviewed, approved, and implemented in a controlled manner.

• Change control is essential for maintaining the stability and integrity of a system.

• It involves documenting and tracking all proposed changes, including their impact and risks.

• Changes are reviewed and approved by a designated change control board or committee.

• Proper testing and val...read more

Risk management is the process of identifying, assessing, and prioritizing potential risks and taking measures to minimize or mitigate their impact.

• Identifying potential risks

• Assessing the likelihood and impact of each risk

• Prioritizing risks based on their severity

• Developing strategies to minimize or mitigate risks

• Implementing risk management plans

• Monitoring and reviewing risks regularly

• Examples: financial risk, cybers

VMP stands for Vendor Master Plan. It is a strategic document that outlines the approach and activities for managing vendors in an organization.

• VMP is a comprehensive plan that includes vendor selection, evaluation, and performance management.

• It defines the criteria for selecting vendors and the process for evaluating their performance.

• The plan also outlines the responsibilities and roles of various stakeholders involv...read more

Incident is an unexpected event that may or may not have an impact on product quality, while deviation is a planned or intentional change that may affect product quality.

• Incident is unplanned, while deviation is planned

• Incident may or may not have an impact on product quality, while deviation may affect product quality

• Incident requires investigation to determine the root cause, while deviation requires investigation to...read more

The Ich limit for methanol is 0.6% and it is classified as a class 3 solvent.

• The Ich limit for methanol refers to the maximum allowable amount of methanol in a pharmaceutical product.

• The Ich limit for methanol is set at 0.6%, meaning that the concentration of methanol should not exceed 0.6% in the product.

• Methanol is classified as a class 3 solvent according to the International Council for Harmonisation of Technical R...read more

The specification limit for known and unknown impurities varies depending on the specific substance being tested.

• The specification limit for known impurities is typically set by regulatory agencies or pharmacopoeias.

• For example, the United States Pharmacopeia (USP) sets limits for known impurities in pharmaceutical substances.

• The specification limit for unknown impurities is usually determined through method validation...read more

P2P cycle refers to the process of procuring goods or services from a supplier and making payments for them.

• The cycle starts with identifying the need for goods or services.

• The next step is to create a purchase order (PO) and send it to the supplier.

• The supplier then delivers the goods or services and sends an invoice to the buyer.

• The buyer verifies the invoice and matches it with the PO and goods received.

• If everythin...read more