Validation Executive Interview Questions and Answers

The guidelines for equipment qualification vary depending on the industry and regulatory requirements.

• In the pharmaceutical industry, equipment qualification is guided by regulations such as Good Manufacturing Practices (GMP) and the International Conference on Harmonisation (ICH) guidelines.

• For medical devices, the guidelines may include the FDA's Quality System Regulation (QSR) and the ISO 13485 standard.

• In the food industry, equipment qualification may be guided by regulat...read more

Discrepancy refers to a difference or inconsistency between two or more pieces of information. It is used to identify and resolve errors or inconsistencies in data.

• Discrepancy is commonly used in quality control and validation processes.

• It can be identified through comparing data from different sources or through manual review.

• Examples of discrepancies include mismatched data, missing information, or conflicting data.

• Discrepancies should be resolved before finalizing data or ...read more

Yes, I perform validation activities as part of my job responsibilities.

• I am responsible for ensuring that all processes and systems meet regulatory requirements.

• I conduct validation tests and document the results.

• I work closely with cross-functional teams to identify and address any issues that arise during the validation process.

• Examples of validation activities I have performed include software validation, equipment validation, and process validation.

21 CFR Part 11 is a regulation by the FDA that defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

• 21 CFR Part 11 applies to electronic records and electronic signatures used in FDA-regulated industries, such as pharmaceuticals, medical devices, and biologics.

• It requires that electronic records be secure, accurate, and accessible, and that electronic signatures be unique, verifiabl...read more

Validation is the process of ensuring that something is accurate, reliable, and meets the required standards.

• Validation is a systematic and objective approach to assess the accuracy and reliability of data, processes, systems, or products.

• It involves comparing the results or outputs of a process or system with the expected or desired outcomes.

• Validation can be performed through various methods such as testing, inspection, analysis, or documentation review.

• For example, in soft...read more

GAMP 5 is a category for software validation in the pharmaceutical and biotech industries.

• GAMP 5 stands for Good Automated Manufacturing Practice 5.

• It provides guidelines for the validation of automated systems in the pharmaceutical and biotech industries.

• It categorizes software based on its impact on product quality and patient safety.

• The categories range from Category 1 (low impact) to Category 5 (high impact).

• Examples of Category 5 software include systems that control cri...read more

Validation ensures that a product or process meets the required standards and specifications.

• To ensure safety and efficacy of products

• To comply with regulatory requirements

• To minimize risks and errors

• To improve quality and reliability

• To gain customer trust and confidence