Top cGMP Interview

Questions and
Answers

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 Section 1 Basic CGMP Concepts

Question 1

What is Quality Assurance?

Response

Quality assurance (QA) is the systematic process of ensuring product quality by monitoring each
stage of production. It covers all activities and decisions related to maintaining quality, from material
sourcing to final product release. QA sets standards and procedures to ensure safety, effectiveness,
and consistency. By implementing QA, companies prevent issues rather than reacting to them. This
approach helps meet regulatory requirements and customer expectations.

Question 2 What are In-Process Checks?

Response

In-process checks are tests or inspections performed during manufacturing. They ensure that each
stage of production meets quality standards before moving on to the next step. For example,
checking tablet weight or solution concentration ensures consistency. These checks help identify
potential issues early in production. In-process checks maintain product quality throughout
manufacturing.

Question 3 What is Documentation in CGMP?

Response

Documentation includes all records that describe procedures, actions, and results. It ensures
traceability by detailing each step in manufacturing, from raw materials to final product testing.
Proper documentation provides evidence of quality and compliance with CGMP regulations. It
includes standard operating procedures (SOPs), batch records, and test results. This system ensures
transparency, accountability, and control in production.

Question 4 What is a Change Control?

Response

Change control is a process for managing and documenting modifications in manufacturing or

procedures. It ensures that all changes are evaluated for potential impacts on product quality. Each
change must be approved and justified before being implemented. This system helps maintain
consistency and reliability in production. It also provides a documented history of all changes,
helping in audits and inspections.

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 Question 5 What is an SOP?

Response

An SOP (Standard Operating Procedure) is a detailed guide for performing a task or activity. It
provides step-by-step instructions to ensure consistency, efficiency, and quality. SOPs are essential
for maintaining standard practices, especially in regulated industries like pharmaceuticals. They help
train employees and reduce errors in critical processes. By following SOPs, companies ensure
compliance with CGMP standards.

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 Section 2 Intermediate CGMP and Quality Control

Question 6 What is a Batch Manufacturing Record (BMR)?

Response

A BMR is a document that records every detail of a batch production. It includes information such as
raw materials used, quantities, equipment settings, and results from in-process checks. The BMR
serves as proof that each batch was produced following CGMP guidelines. It helps in investigating
any issues that arise with a specific batch. BMRs provide traceability and ensure consistency across
production.

Question 7 What is the difference between BMR and BPR?

Response

A BMR (Batch Manufacturing Record) is for manufacturing, while a BPR (Batch Packaging Record) is
for packaging. BMR includes details of materials, processes, and testing during manufacturing. BPR
focuses on packaging specifications, labeling, and storage conditions. Both documents ensure that
manufacturing and packaging comply with quality standards. Together, they provide a complete
record of each product batch.

Question 8 What is Validation in CGMP?

Response

Validation is the process of confirming that equipment, processes, and methods work as intended
and produce consistent, high-quality results. It provides documented evidence that a process or
system achieves desired outcomes under controlled conditions. Validation includes testing,
reviewing, and documenting each step. This ensures that products meet quality, safety, and
regulatory standards. Validation helps companies maintain consistent and reliable manufacturing
processes.

Question 9 Why is Calibration Important?

Response

Calibration ensures that instruments used in production are accurate and reliable. It adjusts and
verifies the performance of instruments to meet specified standards. Regular calibration reduces
measurement errors and ensures product quality and consistency. For example, scales and
thermometers are calibrated to ensure correct measurements. Proper calibration is essential for
maintaining CGMP compliance.

Question 10 What is 21 CFR Part 11?

Response

21 CFR Part 11 is a set of FDA regulations for managing electronic records and electronic signatures.
It ensures that electronic documents are accurate, secure, and accessible when needed. This
regulation applies to systems that store critical manufacturing, testing, or quality records. It ensures
data integrity by setting standards for access control, audits, and electronic signatures. Compliance
with 21 CFR Part 11 is mandatory for CGMP.

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 Section 3 Advanced CGMP Processes

Question 11 What is Positive Pressure and Why is it Used?

Response

Positive pressure is a condition where the air pressure inside a room is higher than outside. It is used
to prevent contamination by ensuring that only clean air flows out, not in. Positive pressure is
especially important in areas where sterile products are handled. By maintaining higher pressure,
the risk of contamination from adjacent areas is minimized. This technique helps in controlling the
production environment.

Question 12 What is a Deviation in CGMP?

Response

A deviation is any unexpected event that happens during manufacturing, testing, or storage and
could affect product quality. It includes issues like equipment malfunction, incorrect measurements,
or out-of-specification results. Deviation reports document these incidents, including investigations
and corrective actions. Managing deviations helps identify and fix root causes to prevent future
issues. Proper deviation management maintains product quality and regulatory compliance.

Question 13 What is Process Validation?

Response

Process validation confirms that a production process consistently produces products of required
quality. It involves detailed testing, data collection, and analysis across different production stages.
Process validation is divided into three stages: process design, process qualification, and continued
process verification. Each stage demonstrates that the process remains in control under regular
conditions. This ensures product quality and regulatory compliance.

Question 14 What is a Validation Master Plan (VMP)?

Response

A VMP is a comprehensive document that outlines all validation activities for facilities, systems, and
equipment. It details the scope, purpose, and schedule of validation activities, and identifies
resources and responsibilities. The VMP guides the validation team and helps ensure that all
processes meet quality standards. It is a critical document for audits and inspections. A well-
prepared VMP ensures organized and efficient validation processes.

Question 15 What is a Market Complaint?

Response

A market complaint is a reported issue from customers regarding a product’s quality, safety, or
efficacy. Common issues include defective packaging, incorrect labeling, or substandard product
performance. All complaints must be recorded, investigated, and resolved promptly. Market
complaints help companies identify and correct product issues to improve quality. Regulatory
authorities may inspect complaint records to ensure companies address quality issues properly.

Question 16 What is a Product Recall?

Response

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 A product recall is the process of retrieving defective or potentially harmful products from the
market. Recalls may happen due to quality issues, safety concerns, labeling errors, or contamination
risks. Companies follow a structured procedure to inform distributors, retailers, and customers. A
recall is a critical step in protecting public health and maintaining company credibility. It also helps
prevent legal consequences from defective products.

Question 17 What is Vendor Qualification?

Response

Vendor qualification is the process of assessing and verifying that a supplier meets CGMP standards.
It ensures that the raw materials or components provided by the vendor are safe, consistent, and
meet quality requirements. Companies often conduct audits, review documentation, and assess
quality systems. Qualified vendors help maintain consistent product quality and reduce risks of
contamination or errors. Vendor qualification is essential for reliable supply chain management.

Question 18 What is Cleaning Validation?

Response

Cleaning validation ensures that equipment is cleaned effectively, reducing the risk of cross-
contamination between products. It provides documented evidence that a cleaning process
consistently removes residues, preventing contamination in subsequent batches. Cleaning validation
includes testing for contaminants like product residues, microbial contamination, and cleaning agent
residues. This validation is critical for maintaining product quality and CGMP compliance. Effective
cleaning validation protects patient safety.

Question 19 What is an Annual Product Quality Review (APQR)?

Response

An APQR is a yearly review of product data to assess quality and consistency over time. It includes
information on raw material quality, deviations, complaints, and stability data. By reviewing this
information, companies identify trends, improve processes, and make quality improvements. The
APQR also ensures compliance with regulatory standards by addressing potential quality risks. This
review is essential for maintaining consistent product quality.

Question 20 What are Critical Quality Attributes (CQAs)?

Response

CQAs are the physical, chemical, biological, or microbiological characteristics that directly impact
product quality. Examples include drug potency, purity, stability, and disintegration time for tablets.
CQAs are identified during product development and are monitored throughout manufacturing.
Managing CQAs ensures that products meet desired quality standards and regulatory requirements.
CQAs are central to quality risk management and process validation.

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 Section 4 Expert CGMP Topics

Question 21 What is Out of Specification (OOS)?

Response

An OOS result occurs when a test result does not meet predefined acceptance criteria. It requires
investigation to determine if it was due to lab error, equipment malfunction, or production issues.
Documenting and investigating OOS helps identify and address quality risks. Regulatory guidelines
mandate reporting and documenting OOS results. Correcting OOS results is critical to maintaining
quality standards.

Question 22 What is Quality Risk Management (QRM)?

Response

QRM is a systematic approach to identifying, assessing, and controlling quality risks. It involves tools
like Failure Mode Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP).
QRM helps prioritize and mitigate risks that could impact product safety or efficacy. By managing
quality risks, companies maintain CGMP compliance and reduce potential issues in production.
Effective QRM improves product reliability and patient safety.

Question 23 What is Root Cause Analysis?

Response

Root cause analysis investigates the underlying cause of an issue or deviation. The goal is to identify
why a problem occurred to prevent recurrence. Techniques include “5 Whys” and fishbone diagrams
to systematically explore possible causes. Documenting root causes and corrective actions ensures
transparency and continuous improvement. Effective root cause analysis helps maintain consistent
quality and prevent future issues.

Question 24 What is an Analytical Method Validation?

Response

Analytical method validation proves that a testing method provides reliable and accurate results. It
includes validating parameters like specificity, precision, accuracy, and sensitivity. This process
ensures that test methods produce consistent, repeatable results under different conditions.
Method validation is essential for testing product quality attributes, ensuring regulatory compliance.
It confirms that analytical methods are suitable for their intended purpose.

Question 25 What is Analytical Method Validation?

Response

Analytical method validation is the process of proving that a testing method is reliable, accurate, and
reproducible. It includes evaluating precision, accuracy, specificity, and linearity of the method.
Validated methods ensure that test results are trustworthy for making quality decisions. This is
essential for tests used to evaluate raw materials, intermediates, and final products. Proper
validation prevents misinterpretation of test results and supports regulatory compliance.

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 Section 5 Advanced CGMP and Regulatory Compliance

Question 26 What is a Quality Management System (QMS)?

Response

A QMS is an organizational framework that defines and manages all quality-related

processes and responsibilities. It includes policies, procedures, and documentation to ensure
product quality and regulatory compliance. QMS covers areas like training, deviation
management, change control, and audits. A strong QMS supports consistent, high-quality
production and continuous improvement. It helps companies meet CGMP standards and
maintain regulatory approvals.

Question 27 What is Cross-Contamination and How is it Prevented?

Response

Cross-contamination occurs when foreign substances, such as other products or chemicals,

unintentionally enter a product batch. It can compromise product safety and quality, posing
serious risks to patients. Preventing cross-contamination involves measures like dedicated
equipment, proper cleaning, controlled air pressure, and gowning requirements. Staff training
and adherence to SOPs are also essential. Preventing cross-contamination is critical to
meeting CGMP and safety standards.

Question 28 What is Good Documentation Practice (GDP)?

Response

GDP refers to a set of principles for managing documents to ensure accuracy, consistency,
and traceability. It includes rules for document creation, modification, review, and storage.
GDP requires that records be complete, legible, dated, and signed by authorized personnel. It
is a fundamental part of CGMP, as it helps maintain clear and auditable records of all
activities. Adhering to GDP minimizes errors and enhances regulatory compliance.

Question 29 What is a Critical Control Point (CCP) in Manufacturing?

Response

A CCP is a specific step in the manufacturing process where control is essential to prevent or
eliminate quality risks. Identifying CCPs allows for focused monitoring and ensures that key
aspects of the product are within specification. For example, sterilization steps in aseptic
processing are often CCPs. Controlling CCPs is critical for maintaining product safety,
efficacy, and consistency. Monitoring CCPs helps maintain compliance with CGMP
standards.

Question 30 What is a Clean Hold Time in Cleaning Validation?

Response

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 Clean hold time refers to the allowable time that cleaned equipment can remain unused
before it needs re-cleaning. This time limit ensures that equipment does not become
contaminated due to environmental exposure. Clean hold times are determined through
studies and verified during cleaning validation. Adhering to this limit maintains the quality
and safety of the next production batch. It’s essential for maintaining compliance and
avoiding contamination risks.

Question 31 What is Continuous Process Verification?

Response

Continuous process verification is the ongoing assurance that a manufacturing process

remains in a state of control during routine production. It involves real-time monitoring of
critical quality attributes and process parameters. This approach reduces reliance on end-
product testing and ensures that quality is built into the process. Continuous verification is
particularly useful for complex or high-risk processes. It helps in early detection of issues
and continuous quality improvement.

Question 32 What is Good Automated Manufacturing Practice (GAMP)?

Response

GAMP is a set of guidelines for designing, implementing, and validating automated systems
used in pharmaceutical manufacturing. It provides a risk-based approach to ensure that
automated systems consistently meet CGMP standards. GAMP guidelines help companies
maintain control over software, equipment, and processes to ensure data integrity. GAMP
principles are applied in areas like computerized system validation and electronic record
management. Following GAMP reduces the risk of errors and ensures reliable automated
processes.

Question 33 What is a Risk Assessment in Quality Management?

Response

Risk assessment is the process of identifying, evaluating, and prioritizing potential risks to
product quality. It involves analyzing the likelihood and impact of quality issues and
implementing measures to reduce risks. Tools like FMEA, HACCP, and root cause analysis
are commonly used in risk assessment. Effective risk assessment helps companies
proactively address issues and prevent quality failures. It is a core part of quality risk
management under CGMP.

Question 34 What is a Process Analytical Technology (PAT)?

Response

PAT is a regulatory framework that promotes the use of real-time data to understand and
control manufacturing processes. By using analytical tools and sensors, PAT enables
manufacturers to monitor critical quality attributes during production. This approach allows
for continuous adjustment and control of processes, ensuring consistent product quality. PAT
helps reduce batch failures and improve efficiency. Implementing PAT supports a more
dynamic, science-based manufacturing approach.
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 Question 35 What is a Certificate of Analysis (COA)?
Response

A COA is a document that certifies the quality and specifications of a raw material or
finished product. It lists test results for key attributes, such as purity, potency, and microbial
limits. Suppliers provide COAs for each batch of material, allowing manufacturers to verify
quality before use. COAs are essential for traceability and ensuring that materials meet
quality requirements. They are important in audits and regulatory inspections.

Question 36 What is an Out of Trend (OOT) Result?

Response

An OOT result occurs when a test value deviates from expected historical trends but remains
within the specification limits. OOT investigations help identify potential quality shifts that
may not immediately impact compliance. This proactive approach can reveal early signs of
process variation or instability. Investigating OOT results helps companies address potential
issues before they become critical. Managing OOT results supports continuous process
improvement and CGMP compliance.

Question 37 What is the Difference Between Retesting and Re-sampling?

Response

Retesting involves conducting another test on an existing sample to confirm results, often
after an out-of-specification (OOS) finding. Re-sampling, however, involves collecting a new
sample to re-evaluate a batch's quality. Retesting addresses issues that may have resulted
from lab errors, while re-sampling addresses potential issues in the batch itself. Each action
has specific guidelines, and both are used to maintain product quality and regulatory
compliance. Proper documentation of both processes is essential for audits.

Question 38 What is the Purpose of a Stability Study?

Response

Stability studies evaluate how a drug product maintains its quality over time under various
environmental conditions. These studies determine the product’s shelf life, storage
conditions, and expiration date. Data from stability studies helps in labeling and packaging
design to ensure product quality during distribution. Stability testing includes testing for
potency, purity, and physical changes over time. This process is vital for ensuring patient
safety and regulatory approval.

Question 39 What is the Importance of Environmental Monitoring in CGMP?

Response

Environmental monitoring checks for microbial and particulate contamination in the

manufacturing environment. It ensures that areas like cleanrooms meet air quality and
cleanliness standards. Monitoring helps maintain controlled conditions to prevent
contamination of sterile products. Results are documented and reviewed regularly to detect

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 any trends or potential risks. Effective environmental monitoring is essential for CGMP
compliance and patient safety.

Question 40 What is the Purpose of Quality Audits?

Response

Quality audits are systematic evaluations of an organization’s processes, systems, and

documents to ensure compliance with CGMP and quality standards. Internal audits are
conducted by the company to find and correct potential issues, while external audits by
regulatory bodies assess compliance. Audits help identify gaps, improve practices, and verify
that quality systems are functioning as intended. They provide assurance that products are
consistently produced to quality standards. Regular audits are essential for maintaining
CGMP compliance and continuous improvement.

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