Quality Assurance (QA) Interview Questions and Answers

Quality assurance in a pharmaceutical industry, is a profession which act to implement the quality systems and processes to ensure that products consistently meet quality standards. Here we mentioned a list of common interview questions and answers on quality assurance:

Q. What is SOP?

A written authorized procedure which gives detail instructions for performing operations.

Q. What are the contents of the SOP?

Objective/Purpose, Scope, Responsibility, Procedure, List of formats/Annexure, Abbreviations, Reference, Revision History etc.

Q. What are the major SOPs required in QA department?

SOP for SOP
Change control
Deviation
Market complaints
Product recall
Vendor qualification
Preparation of BMR & BPR
Annual product review
Corrective action & preventive action
Process validation
Cleaning validation
Document control
Batch release, self
Inspection (internal audit)
Reprocess & rework
Measurable quality objectives etc.

Q. What is the difference between GMP & cGMP?

GMP is the part of Quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. Such risks are essentially of two types:

Cross-contamination (in particular of unexpected contamination)
Mix-ups (confusion)

cGMP means current procedure / system adopted by the manufacturer which proves to be necessary and important for identity, strength and purity of a product.

Q. What is the difference between Qualification and Validation?

Qualification is equipment / instrument oriented but validation is process oriented.

Q. What is the definition of Validation?

Validation is the documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting predetermined acceptance criteria.

Q. What are the types of validation?

Process validation, Analytical method validation, cleaning validation, facility validation, Utility validation & software validation.

Q. What is the prospective, concurrent and retrospective validation?

Prospective process validation: Prospective Process validation shall be carried out for all of the new drug products prior to the distribution. [ICH: GMP, EU: GMP, PIC/S: GMP]
Concurrent process validation: Any validated process undergoes a change either for the equipment or addition, deletion of a critical manufacturing process step, scale up or scale down, the same needs to be validated concurrently.
Retrospective process validation: Validation of a process for a product already in distribution based upon accumulated production, testing and control data. [ICH: GMP, EU: GMP, PIC/S: GMP]

Q. What do you mean by validation protocol and its contents of process validation?

A written plan stating, how validation will be conducted and defining acceptance criteria e.g: The protocol for manufacturing process identifies process equipments, critical process parameters, and / or operating range, product characteristics, sampling, test data to be collected, number of validations runs and acceptance test results.

Contents:

Protocol Approval
Table of contents
Objective
Scope
Responsibility
Accountability
Validation team
Brief manufacturing process (Description, Flow chart, Reaction scheme)
Selection of batches
List of equipments used in the manufacturing process
List of raw materials used in the manufacturing process
Critical operations with justification
In-process controls with acceptance criteria
Sampling & testing plan with frequency
Stability programm
Data to be complied
Acceptance criteria
Intermediate & final products quality & yield
Stability specification
Document review
Conclusion
Revalidation criteria

Q. What is the master document?

Master document is a formally authorized source document relating to specifications, and / or manufacturing / analytical methods, which is protected from un-authorized access or amendment.

Q. What are the classifications of residual solvents?

Residual solvents are classified into three class based on the possible risk to human health:

Class-I (Solvents to be avoided)
Class-II (Solvents to be limited)
Class-III (Solvents with low toxic potential)

Q. What is the abbreviation of MSDS and what are the contents of MSDS?

MSDS means Material Safety Data Sheet and it contains:

Product Identification
Composition / Information on Ingredients
Hazards identification
First Aid measures
Fire fighting measures
Accidental release measures
Handling & storage
Exposure controls / Personal protection
Physical & Chemical properties
Stability & Reactivity
Toxicological information
Ecological information
Disposal consideration
Transport information
Regulatory information
Other information

Q. What is audit/inspection and Why quality audit? Write different types of audits/inspection?

Audit is a planned and systematic examination and check of a system, procedure or operation in order to monitor compliance with and the effectiveness of established standards and to allow for improvement and corrective measures where required.

Quality audit because of:

To assess the effectiveness of the quality management system
Assessing conformance
Investigating problems
Continual improvement of performance
Assessing for Registration
Reducing cost of operation
Legal requirement

Types:

Pre-approval inspection
Facility based GMP inspection
Process based inspection

Q. What is expiry date & re-test date?

Expiry date: The date place on the container / labels of an API designated the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions and after which it should not be used.

Re-test date: The date when a material should be re-examined to ensure that it is still suitable for use. The period of time during which the drug substance is expected to remain within its specifications and therefore, can be used in the manufacturing of the drug product, provided that drug substance has been stored under the defined conditions.

Q. What is deviation & its types?

Deviation is departure from the approved instructions /established standards. There are two types of deviation and given below:

Controlled / planned deviation: Any deviation from documented procedure opted deliberately for temporary period to manage unavoidable situation or improving the performance of the operations, without affecting the quality & yield of drug substance and safety of the operations shall be termed as controlled / planned deviation.

Uncontrolled / unplanned deviation: Any deviation occurred in unplanned or uncontrolled manner such as system failure or equipment breakdown or manual error shall be termed as uncontrolled / unplanned deviation.

Q. What is change control and its types?

Change control is a system that control change by –

Identifying ownership of the change
Allowing for review and approval of the change.
Preventing changes that could adversely affect product quality or conflict with registration or regulatory requirement.
Providing an assessment of change and monitors the impact of change.

Types:

Minor: Are those that are unlikely to have any detectable impact on the quality attributes of the product.
Major: Are those that are likely to have a significant impact on the quality attributes of the product.

Q. What is contamination and cross-contamination?

Contamination: The undesired introduction of impurities of a chemical or Microbiological nature, or of foreign matter, in to or onto a raw material, intermediate, or API during production, sampling, packaging or repackaging, storage or transport.
Cross-contamination: Contamination of a material or of a product with another material or product.

Q. What is quarantine?

The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection.

Q. What is OOS?

Out of Specification (OOS) results are those results, generated during testing that do not comply with the relevant specification or standards or with the defined acceptance criteria.

Q. What is OOT?

“OOT” stands for Out Of Trend. It means any test results obtained for a particular batch that is markedly different the results of the batches in a series obtained using a same validated method.

Q. What is CAPA?

CAPA is the Corrective Action & Preventive Action.

Corrective Action: Action taken to eliminate the causes of an existing non-conformity, defect or other undesirable situation to prevent recurrence. [Actions taken after the occurrence of a defect or problem to stop the same from recurrence].
Preventive Action: Action taken to eliminate the causes of potential non-conformity, defect or other undesirable situation to prevent occurrence. [Actions initiated before the occurrence of a defect or problem to prevent the same occurrence]

Q. What is cleaning validation?

Cleaning validation is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing of pharmaceutical products or APIs.

Cleaning validation is the confirmation of reliable cleaning products so that the analytical monitoring may be omitted or reduced to a minimum in the routine phase.

It describes the validation of cleaning procedures for the removal of contaminants associated with the previous products, residues of cleaning agents as well as the control of potential microbial contaminants.

Q. What is the efficiency of the High Efficiency Particulate Air (HEPA) filter?

This type of air filter can remove at least 99.97% particles in air up to 0.3μm in diameter.

Q. What are cGMP requirements for building and facilities?

Following are the cGMP requirements:

Suitable size, appropriate construction and location
Facilitate cleaning, maintenance and proper operation
Adequate space
Defined areas of adequate size
Water supply: continuous and of good quality
Power supply: continuous
Adequate lighting, ventilations, air filtration, plumbing sewage, toilet facilities.

Q. What is critical process parameter?

A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.

Q. What do you mean by Critical Quality Attributes?

A critical quality attributes is a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.

Q. Describe the categories of the market complaints?

Market complaints are categorized into three types and are as follows:

Critical: Complaints related to suspected contamination, adulteration and mislabeling.
Major: Complaints related to the product not meeting its pre-determined critical specifications and damage to primary packaging.
Minor: Complaints related to the product not meeting non-critical quality attributes, or damage to secondary packaging or shortages etc.

Q. What is the definition of document control?

Document control ensures that documents are reviewed for adequacy, approved for release by authorized personnel and distributed to and used at the location where the prescribed activity is performed.

Q. What is the difference between controlled copy and un-controlled copy?

Controlled copy: A controlled copy is a formal copy of the latest, correct issue of a document; an identified issue of a document to an individual or location of record. The controlled copy is officially tracked, updated & destroyed to assure that it is current.

Uncontrolled copy: An informal copy of a document for which no attempt is made to update if after distribution; the document is marked “uncontrolled” and the user determines if the document is active prior to use.

Q. What do you mean by re-validation?

A repeat of the process validation to provide an assurance that changes in the process/equipments introduced in accordance with change control procedures do not adversely affect process characteristics & product quality.

Q. What is a DMF?

A DMF is a package of proprietary information filed voluntarily by a company with the FDA. If it held by them in confidential closed files until such time as an FDA reviewer requests a review

Q. What is the QMS?

It is the quality management system to direct and control an organization with regard to quality.

Q. What is Master validation Plan (VMP)?

A document providing information on the company’s validation work program. It should define details of and time scales for the validation work to be performed. Responsibilities relating to the plan should be stated.

Q. What do you mean by product recall?

Products recall means removal or withdraw of marketed material due to violation in laws & regulations as per regulatory authorities or not conforming to the customers’ specifications.

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