Senior Executive Quality Control Interview Questions and Answers

Computer systems used in the medical field must be compliant with 21 CFR part 11.

• Electronic medical record systems

• Laboratory information management systems

• Pharmacy management systems

• Clinical trial management systems

• Medical device software

• Electronic data capture systems

Both 21 CFR part 11 and EU Annex 11 are equally precise for computer system.

• Both regulations provide specific guidelines for electronic records and signatures.

• 21 CFR part 11 applies to FDA-regulated industries in the US, while EU Annex 11 applies to pharmaceutical companies operating in the EU.

• Both regulations require validation of computer systems and controls to ensure data integrity and security.

• EU Annex 11 places more emphasis on risk management and data privacy.

• Complianc...read more

Toilet soap is used for personal hygiene while laundry soap is used for washing clothes.

• Toilet soap is formulated with ingredients that are gentle on the skin.

• Laundry soap is designed to remove tough stains and dirt from clothes.

• Toilet soap comes in various forms such as bars, liquid, and foam.

• Laundry soap is available in powder, liquid, and bar forms.

• Toilet soap may contain moisturizing agents like glycerin and shea butter.

• Laundry soap may contain enzymes and surfactants to ...read more

I handle quality deviation by identifying the root cause, implementing corrective actions, and monitoring the effectiveness of the solution.

• Investigate the deviation thoroughly to identify the root cause

• Implement corrective actions to prevent recurrence

• Communicate the deviation and corrective actions to relevant stakeholders

• Monitor the effectiveness of the solution to ensure sustained improvement

• Document the deviation and corrective actions taken for future reference

ICH guideline provides recommendations for conducting stability studies on pharmaceutical products.

• ICH stands for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

• The guideline outlines the minimum requirements for conducting stability studies on drug substances and drug products

• It includes recommendations on the design, testing conditions, and evaluation of stability data

• Stability studies are conducted to determine the shelf ...read more