QA Interview question and answers:
The following are sample for QA interview questions and answers from the perspective of the Quality Assurance.
Q1: What is Quality Assurance in pharmaceutical industry?
A: Quality assurance covers all the factors that influence product quality individually or collectively. As part of quality assurance, QA primarily focuses on planning and documenting processes to ensure the quality of the product.
Q2: What is ICH?
A: ICH is a short form of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.
Q3: What is cGMP?
A: CGMP stands for Current Good Manufacturing Practice, which is enforced by the FDA.
Q4: What is SOP?
A: Documents such as Standard Operating Procedures (SOPs) provide step-by-step instructions for doing something.
Q5: What is Alcoa Plus?
A: Alcoa plus is stands for
- A = Attributable
- L = Legible
- C = Contemporaneous
- O = Original
- A = Accurate
- C = Complete
- C = Consistent
- E = Endurance
- A = Available
Q6: What is CFR?
A: CFR stands for code of federal regulations.
Q7: What is 21 CFR Part 11?
A: 21 CFR Part 11 deals with FDA guidelines on Electronic Signature and Electronic Records.
Q8: What is change control?
A: The process of managing how changes are introduced into a controlled system is known as change control.
Q9: What is Documentation in pharma?
A: There are various types of documentation including procedures, records, and instructions, along with test records of all quality control activities involved in pharmaceutical manufacturing.
Q10: What is Tablet?
A: A tablet is defined as a solid unit dosage form of medicine with suitable excipients and prepared either by molding or by compression. This preparation consists of a mixture of active ingredients and excipients, usually in powder form, compressed from a powder into a solid dose.
Q11: What is Validation?
A: Documents that provide a high level of assurance that a particular process method or system consistently produces results that meet predetermined criteria.
Q12: What is Calibration?
A: Comparison of measurements with those produced by a traceable standard over an appropriate range of measures to demonstrate that a particular instrument or device produces results within specified limits.
Q13: What is Qualification?
A: A process which proves that a equipment or instrument process works correctly and consistently.
Q14: What is user requirement specification (URS)?
A: Specifications that describe what the equipment or system is supposed to accomplish, thus containing at least a set of criteria or conditions that have to be met.
Q15: What is DQ, IQ, OQ, and PQ?
A: It is process of instrument qualification which includes following stages.
- DQ stands for Design Qualification
- IQ stands for Installation Qualification
- OQ stands for Operational Qualification
- PQ is stands for Performance Qualification
Production, QC and QA interview question and answers
Q16: What is BMR and BPR?
A: BMR is a Batch Manufacturing Records and BPR is a Batch Processing Record.
Q17: What is Quality Control?
A: The primary function of quality control is to check and verify the quality of the product against predefined standards.
Q18: What is Deviation?
A: A deviation is an unexpected event that occurs during the process/processing/documentation/entries of receipt, storage, manufacturing, analysis, and distribution of drug products/intermediate/raw materials/packaging materials.
Q19: What is Recall?
A: Eradication of products marketed for reasons related to quality, safety, or efficacy, including illegal labeling.
Q20: What is Market complaint?
A: Complaints regarding safety, identity, strength, purity, Quality, shortages, or any other such complaint should be treated as market complaints. Complaints can originate from any customer, retailer, distributor, healthcare professional, regulatory agency, patient (Consumer), or field staff.
An expression of dissatisfaction with a product or service is a complaint.
Q21: What is Data Integrity?
A: Integrity refers to the completeness, consistency, and accuracy of data. A complete, consistent, and accurate data set should be attributable, legible, contemporaneously documented, original or a true copy, and accurate (ALCOA).
Q22: What is Meta Data?
A: Metadata is the contextual information required to understand data. Data about data is known as metadata.
A metadata is structured information that describes, explains, or simplifies the process of retrieving, using, or managing data.
Q23: What is Audit Trail?
A: Audit trails allow for the reconstruction of the course of events relating to the creation, modification, or deletion of electronic records. They are secure, computer-generated, time-stamped records.
Q24: What is CAPA?
A: CAPA stands for Corrective Action and Preventive Action.
Q25: What is Form 483?
A: Form 483 is a form where the auditors are recording observation after audit if they found violation.
These are some of the common QA Interview question and answers in pharmaceuticals.
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