10+ Officer QC & QA Interview Questions and Answers

The interviewer asked about melting point, boiling point, pH range, and molecular weight.

• Melting point is the temperature at which a solid turns into a liquid.

• Boiling point is the temperature at which a liquid turns into a gas.

• pH range is the measure of acidity or basicity of a substance.

• Molecular weight is the sum of the atomic weights of all atoms in a molecule.

• These parameters are important in quality control and quality assurance of products.

• For example, the melting point...read more

The buffer used for pH meter calibration is typically a solution with a known pH value.

• Buffers are used to calibrate pH meters to ensure accurate measurements.

• Common buffers used for pH meter calibration include pH 4.01, pH 7.00, and pH 10.01.

• Buffer solutions are prepared using specific chemicals and distilled water.

• The pH meter is calibrated by immersing the electrode in the buffer solution and adjusting the meter to match the known pH value.

• Regular calibration of pH meters ...read more

CAPA stands for Corrective and Preventive Action.

• CAPA is a systematic approach used to identify, investigate, and resolve quality issues.

• It involves analyzing the root cause of a problem and implementing corrective actions to prevent its recurrence.

• Corrective actions address existing issues, while preventive actions aim to prevent potential problems.

• CAPA is an essential component of quality control and assurance processes.

• Example: If a product fails to meet quality standards,...read more

Pharmacy involves the preparation, dispensing, and management of medications to ensure safe and effective use by patients.

• Pharmacy is the science and practice of preparing and dispensing medications.

• Pharmacists play a crucial role in ensuring the safe and effective use of medications by patients.

• Pharmacy also involves medication management, patient counseling, and drug information services.

• Pharmacy technicians assist pharmacists in dispensing medications and managing inventor...read more

Clinical research is the study of drugs, devices, or interventions in humans to determine their safety and efficacy.

• Clinical research involves conducting trials on humans to test the safety and efficacy of drugs, devices, or interventions.

• It is conducted in phases, starting with small studies to determine safety and dosage, and progressing to larger studies to determine efficacy.

• Regulatory affairs involves ensuring that clinical trials are conducted in compliance with regulat...read more

Quality Assurance is a process that ensures products or services meet specified requirements and standards.

• Quality Assurance involves creating and implementing quality control processes.

• It focuses on preventing defects and errors rather than detecting them after production.

• QA includes activities like planning, designing, and executing tests to ensure product quality.

• It also involves monitoring and analyzing data to identify areas for improvement.

• Examples of QA techniques incl...read more

Acceptance criteria for disintegration and dissolution testing, as well as copper content in pharmaceutical products.

• Disintegration testing should meet specified time limits for complete disintegration of tablets or capsules.

• Dissolution testing should meet specified criteria for release of active ingredient(s) from the dosage form.

• Copper content should be within acceptable limits to ensure product quality and safety.

• Acceptance criteria may vary depending on the specific produ...read more

Regulatory affairs involves ensuring compliance with government regulations and guidelines in various industries.

• Regulatory affairs professionals are responsible for obtaining and maintaining regulatory approval for products and services.

• They work closely with government agencies to ensure compliance with regulations and guidelines.

• In the medical field, regulatory affairs involves obtaining approval for drugs, medical devices, and clinical trials.

• In other industries, regulato...read more

The responsibilities of a QA person include ensuring the quality of products or services, identifying and reporting defects, and implementing quality control processes.

• Developing and implementing quality assurance policies and procedures

• Conducting tests and inspections to identify defects and ensure product or service quality

• Documenting and reporting test results and defects

• Collaborating with cross-functional teams to address quality issues

• Implementing quality control process...read more

Calibration of dissolution is a process to ensure accuracy and reliability of dissolution testing equipment.

• Calibration involves verifying the accuracy of the equipment by comparing it to a known standard.

• Regular calibration is essential to maintain the quality and consistency of dissolution testing results.

• Calibration parameters may include temperature, rotation speed, and media pH.

• Examples of calibration standards include USP and EP guidelines for dissolution testing.

• Calibr...read more

Calibration of UV involves verifying the accuracy of the UV equipment by comparing its readings to a known standard.

• Calibration ensures that the UV equipment is providing accurate and reliable measurements.

• Calibration involves adjusting the UV equipment if necessary to bring it into alignment with the standard.

• Regular calibration is important to maintain the quality and accuracy of UV measurements.

• Examples of calibration standards for UV equipment include certified reference ...read more