What Is ALCOA?: Define Quality Assurance

1. Define Quality Assurance.
Ans: Quality Assurance is a broad range of concepts that contains all the matters that
individually or collectively affect the Quality of a product. QA mainly concentrated on
planning and documenting the procedures to ensure Quality.
2. What Is GMP?
GMP stands for Good Manufacturing Practices & it contains guidelines which are given by US-FDA
defined as, GMP is the set of procedures & documentation which ensures that all the products are
manufactured according to the quality standards,
3. Define Validation
Validation is the documented evidence that gives a high level of assurance that a specific process or
method will consistently produce the required level of results with predefined specifications &
quality.
4. What Is Good Documentation Practice GDP?
Good documentation practice or GDP is the collection of standards or internationally accepted
guidelines that are used for creating documents & record keeping and it helps for data integrity.
5. What Is ALCOA?
ALCOA is used for good documentation practices and stands for,
 Attributable
 Legible
 Contemporaneous
 Original
 Accurate
6. What Is SOP?
SOP is the standard operating procedure and it is written instruction about how a task or activity will
be performed.
7. What Is Change Control?
Change control is a documented system in pharmaceutical industries to control & regulate any
changes in the existing system.
8. In Pharmaceutical Industries How We Can Prevent Cross Contamination?
Cross-contamination in various manufacturing areas is prevented by creating a pressure difference
using airlock systems.
9. Write Down Types Of Airlocks?
There are three types of airlocks which are given below,
 Sink Airlock
 Bubble Airlock
 Cascade Airlock
10. What Is cGMP?
 cGMP refers to the Current Good Manufacturing Practices & is defined as,
 cGMP is the use of current standards & systems to provide high-quality products.
 cGMP gives a system that ensures proper design, control & monitoring of the manufacturing
process & facilities.
11. Define Validation
Validation is the documented evidence that gives a high level of assurance that a specific process or
method will consistently produce the required level of results with predefined specifications & quality.
12. What Is Line Clearance?

Line clearance is the activity or process which ensures that the area, line, or equipment is free from
residues, and labels of previous products and is ready for dispensing,manufacturing,printing or packaging
activity.
13. What We Check During Line Clearance?

During line clearance, QA officers check that all the area and equipment are properly cleaned/washed and
there is no leftover of the previous product.
The following main points are checked,
 Area/equipment Identification
 Calibration Record
 Temperature
 Humidity
 Differential Pressure
 Log Books Record
14. What Is Documentation?
All types of written material used in pharmaceutical industries including procedures, SOPs, work
instructions, etc are known as documentation.
15. What needs to be checked during AHU validation?

Ans: During AHU validation, the following tests shall be carried out:
1) Air velocity & number of air changes
2) Airflow pattern (visualization)
3) Differential pressure , temperature, and RH
4) Static condition area qualification
5) Dynamic condition qualification
6) Non-viable count
7) Microbial monitoring
8) Area recovery and power failure study
Difference between validation and calibration?

Ans: Validation provides written evidence to ensure that a particular method or operation
continuously develops a product with predetermined requirements and quality credits. It is
performed according to the validation protocol.
Calibration denotes that Equipment produces the values in specified limits by comparing the
values produced by a standard. It Is done according to the calibration SOP.
What is 21 CFR part 11?

Ans: Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug
Administration (FDA) guidelines on electronic records and electronic signatures in the United
States.
What is VMP?
Ans: VMP Means Validation master plant. It is about brief information about the Qualification,
Validation, and calibration of Equipment, instruments, and systems. VMP is a type of document
providing information on the company’s Validation work program. Responsibility related to
VMP should be stated.
What are Market Complaints?
Ans: A complaint includes any expression of dissatisfaction with a marketed product or service.
Any written or genuine verbal communication received directly from a customer, retailer,
distributor, healthcare professional, regulatory agency, patient (consumer), or field staff
regarding the safety, identity, strength, purity, quality, shortages, or any other such complaint
should be treated as a market complaint.
What is a Product recall?

Ans: Product recall is the Removal or correction of marketed products for
reasons relating to deficiencies in Quality, safety, or efficacy, including
labeling considered to violate the laws.
Q.35 Vendor Qualification?

Ans: New Vendor: Manufacturer identified by Formulation Development or
purchase department as a manufacturer supplying a specific material from
a specific manufacturing site.
Approved Vendor: Manufacturer of raw material, primal, and printed

packaging material, approved by QA to supply specific material from a
specific site, based on the cGMP.
Cleaning Validations?
Ans: DEFINITION: Cleaning Validation is the documented evidence that an approved cleaning
procedure will provide Equipment suitable for processing medicinal products.
Q.37 What is Annual Product Quality Review (APQR):

Ans: Annual Product Quality Review (APQR) is a documented regular periodic or rolling
quality review of all licensed medicinal products. It verifies the consistency of the existing
manufacturing process, highlights any trends, and identifies product and process improvements
or weaknesses for licensed medicinal products. It assesses the appropriateness of current
specifications for both starting materials and finished products.
Explain Qualifications and their flow

Ans: Design Qualifications , installation Qualifications, Operational Qualifications, and
Performance Qualifications. Flow=URS >> FAT >>SAT >>DQ>>IQ>>OQ>>PQ.
What is a Critical Quality Attribute?
Ans: it is chemical, physical, biological, and microbiological characteristics that should be
under limits and range to ensure the Quality of the products.
Q.50 What is OOS (Out of Specification)?

Ans: A result that falls outside established acceptance criteria established in official compendia
and by company documentation.
What is OOT (Out of TREND)?

Ans: Results of a drug substance of a selected batch, which is within the specification limit but
a similar result compared to other batches of a similar drug substance, falling outside the typical
results of all compared batches.
Or
specification results may be within limits but show a significant change from the historical
results.
What is process validation?

Ans: As per EMA Definition process validation is “documented evidence that of a method,
operated within established parameters, that can be performed effectively and reproducibly to
provide a medicinal product meeting as per its predetermined specifications and quality
attributes.”
What is the Validation Protocol?

Ans: A written plan of action stating how process validation will be conducted; it will specify
who will conduct the various tasks and define testing parameters; sampling plans, testing
methods, and specifications; will specify the product and its characteristics And Equipment to
be used.
It must specify the number of batches and acceptance criteria to be used for validation studies;
and who will sign/approve or Disapprove the conclusions derived from such a scientific study.
Define Clean hold time

Ans: The clean hold time is defined as the time between the completion of cleaning and the
initiation of the subsequent manufacturing operation.
Q.76 Define Dirty hold time

Ans: The dirty hold time is defined as the time between the end of the manufacturing operation
and the beginning of the cleaning process.
What is the difference between Responsibility and Accountability?

Ans: Responsibility: Personnel directly associated with the implementation of the procedure
Accountability: Person directly associated with the implementation of the system under
which the procedure falls.
Q.95 Why is nitrogen gas used in the manufacturing area at room temperature and why
not other gas?
Ans: Because nitrogen is chemically less reactive and does not react with other elements at
ordinary temperatures. It is due to strong bonding in its molecules.
What is Quarantine?
Ans: The status of materials isolated physically or by other effective means pending a decision
on their subsequent approval or rejection.
Q.101 What is the definition of Critical Process Parameters?

Ans: 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.
Installation qualification (IQ): Documented proof that equipment

and systems have been delivered and installed in accordance with
GMP-critical requirements and statutory safety regulations. Measuring
and control technology, built-in materials, surfaces and quality-
relevant measuring points are tested.
Operational qualification (OQ): Documented proof that the system

functionality defined in accordance with the system specifications is
completely fulfilled within the entire working area and within specified
limits. Qualification report: Approval of the OQ report can be started
with a subsequent PQ or process validation.
Performance qualification (PQ): Documented proof that all the

relevant plant components and systems meet the defined
specifications and requirements in an operating condition.

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1. Define Quality Assurance.

12. What Is Line Clearance?

13. What We Check During Line Clearance?

The following main points are checked,

15. What needs to be checked during AHU validation?

Difference between validation and calibration?

What is 21 CFR part 11?

What is a Product recall?

Q.35 Vendor Qualification?

Approved Vendor: Manufacturer of raw material, primal, and printed

Q.37 What is Annual Product Quality Review (APQR):

Explain Qualifications and their flow

Q.50 What is OOS (Out of Specification)?

What is OOT (Out of TREND)?

What is process validation?

What is the Validation Protocol?

Define Clean hold time

Q.76 Define Dirty hold time

What is the difference between Responsibility and Accountability?

Q.101 What is the definition of Critical Process Parameters?

Installation qualification (IQ): Documented proof that equipment

Operational qualification (OQ): Documented proof that the system

Performance qualification (PQ): Documented proof that all the

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