Test - Manuf Lab - Quizlet

12/6/22, 12:15 AM Test: MANUF LAB | Quizlet 12/6/22, 12:15 AM Test: MANUF LAB | Quizlet
Name: Score: Definition 4 of 64

○ pH Value
○ Tablet Hardness
64 Written questions
○ Weight Variation
Definition 1 of 64 ○ Dissolution Time
The
○ Content Uniformity
manufacturing process resulting in

○ Viscosity or Density
commercial product. For the purposes of this guidance, the

○ Colour Uniformity
term commercial manufacturing process does

○ Particle Size Distribution
not include clinical trial or treatment IND

○ Average Unit Potency
material.
Definition 5 of 64
Definition 2 of 64 ○ When the product attribute is not
The degree to which a set of inherent

readily measurable due to limitations
properties of a product, system, or process

of sampling or detectability (e.g., viral
fulfills requirements. clearance or microbial contamination)
or
○ When intermediates and products
cannot be highly characterized and
Definition 3 of 64
well-defined quality attributes cannot
1. Duly accomplished and notarized Integrated
be identified.
Application Form (with proof of payment)
2. Letter of Authorization (where applicable)
3. Certifications*
4. Site Master File

Definition 6 of 64
5. Labeling
a. Valid License to Operate (LTO)
6. Representative Sample with corresponding

(Manufacturer/Packer/Repacker/Trader
Certificate of Analysis (upon request of the

/Distributor/ Wholesaler)
evaluator)
b. Valid GMP certificate
7. Product Information c. Valid agreement between the
manufacturer, trader, distributor

(where applicable)
https://quizlet.com/753294644/test?answerTermSides=2&promptTermSides=6&questionCount=64&questionTypes=1&showImages=true 1/16 https://quizlet.com/753294644/test?answerTermSides=2&promptTermSides=6&questionCount=64&questionTypes=1&showImages=true 2/16

Definition 7 of 64 Definition 12 of 64
Ability of a process 1. For products in plastic container: Certificate
to produce a product that will fulfill the

of Analysis for Test of Migratable Substances /
requirements of that product. The concept of

Leachability
process capability can also be defined in

2. For imported products:
statistical terms. a. Certificate of Pharmaceutical Product
(CPP)
b. Foreign GMP Clearance
3. For fixed-dose combination: Rationale of the
Definition 8 of 64 Combination
combines the actual facility, utilities,

4. Valid LTO (Importer/ Manufacturer/
equipment (each now qualified), and the

Distributor/ Trader)
trained personnel with the commercial
manufacturing process, control procedures,
and components to produce commercial
batches Definition 13 of 64
address variability to assure
quality of the product.
Definition 9 of 64
a. License of pharmaceutical industries
b. GMP certificate of the manufacturer

Definition 14 of 64
c. Copy of "under-license" agreement is based on historical and testing data of
previously manufactured batches. It includes
trends analysis complied and the extent to
which the process is within the permissible
Definition 10 of 64 range of the process parameters.

Process validation scheme outlines the formal process
validation studies to be conducted on the production
scale batches.
Definition 15 of 64
diffusion blender
convective blender
Definition 11 of 64 pneumatic blender

format is acceptable provided that the products are approved
in ICH member countries / regions

Goal: is continual assurance that the process
(1) Building and Capturing Process Knowledge and
remains in a state of control (the validated

Understanding
state) during commercial manufacture. (2) Establishing a Strategy for Process Control
Definition 21 of 64
Definition 17 of 64 (1) After any change having a bearing on
● Carried out during the development stage

product quality.
● Also called pre-market validation

(2) Periodical revalidation.
● Prospective validation results help in finding
(3) Change in batch size.
the risk analysis on the production process. (4) Change in facility and plant
refers to activities undertaken to
a. License to Handle Dangerous Drugs
demonstrate that utilities and equipment are
suitable for their intended use and perform
properly. These activities necessarily precede
manufacturing products at the commercial

Definition 23 of 64
scale. establishing by
objective evidence that all key aspects of the
process equipment and ancillary system
installation adhere to the manufacturer's
Definition 19 of 64 approved specification and that the
● The major equipment, used for the

recommendation of the supplier of the
manufacturing process, are to be identified

equipment are suitably considered.
and the class of each equipment be indicated.
● The equipment are broadly categorized by the
unit operation
Definition 24 of 64
The commercial manufacturing process is
defined during this stage based on knowledge
gained through development and scale-up
activities.

Ongoing assurance is gained during routine
is an authorization or permission embodied in a
production that the process remains in a state

document granted by the FDA to any natural
of control. and juridical person engaged in manufacture,
distribution, importation, exportation, sale,
offer for sale, testing and transfer of the
product.
Definition 26 of 64
can consist of material analysis and
equipment monitoring at significant
processing points Definition 31 of 64

fluid energy mill
impact
cutting
Definition 27 of 64
compression
Confirming that the

screening
manufacturing process as designed is capable
tumbling
of reproducible commercial manufacturing
Definition 32 of 64
Definition 28 of 64
During the process qualification (PQ) stage of
Gravity
process validation, the process design is
power assisted
evaluated to determine if it is capable of
compression coating
reproducible commercial manufacture.
Definition 29 of 64
Definition 33 of 64
a. License of pharmaceutical industries
Releasing for
and contract manufacturer
distribution a lot of finished product,
b. Contract manufacturing agreement
manufactured following a qualification
c. GMP certificate of contract
protocol, that meets the lot release criteria
manufacturer
established in the protocol, but before the
entire study protocol has been executed.

A report documenting and assessing
Stage 1 - Process Design
adherence to the written PPQ protocol should
Stage 2 - Process Qualification
be prepared in a timely manner after the
Stage 3 - Continued Process Verification

completion of the protocol.
Definition 39 of 64
Definition 35 of 64
can help
Measurable values
develop process knowledge by revealing
used to quantify quality objectives to reflect
relationships, including multivariate
the performance of an organization, process or
interactions, between the variable inputs (e.g.,
system, also known as performance metrics in
component characteristics or process
some regions.
parameters) and the resulting outputs (e.g.,
inprocess material, intermediates, or the final
product).
Definition 36 of 64
is needed to assure that modification within
process environments, whether introduced
Definition 40 of 64
intentionally or unintentionally, does not
Assuring
adversely affect the process characteristics and
that during routine production the process
product quality
remains in a state of control.
Definition 37 of 64
Definition 41 of 64
vibratory/shaker
is carried out during the regular production
centrifugal
stage. It is based on a complete examination of
the process based on prospective validation.

During this stage, the process design is
(1) A new product has been prospectively
evaluated to determine if the process is capable

validated in a manufacturing facility.
of reproducible commercial manufacturing. (2) There is no change in the
manufacturing process, and the impact
of change in the manufacturing
process and changes is not significant.
Definition 43 of 64
(3) If there is a change in supplier of raw
1. Prospective Validation
material in the existing production
2. Retrospective Validation
formula
3. Concurrent Validation
4. Revalidation
Definition 46 of 64
vacuum
Definition 44 of 64
auger
(1) Collect data from previously completed
batches.
(2) Organize all data sequences wise, i.e.,
batch manufacturing and expiry date.

Definition 47 of 64
(3) Ten to twenty-five batches or more are
establishing by
used for this purpose, preferably

objective evidence process control limits and
processed over no longer than 12

action levels which result in product those all
months and reviewed together.

pre-determined requirements
(4) Batch rejected during routine quality
control is not included in this review.
Definition 48 of 64
● Option 1: Full submission (S1-S6)
● Option 2: Certificate of Suitability - with
sections/subsections: S1, S2.1, S4.4 and S7 (if
retest period is not stated) only. Copy of the
latest version of the certificate of suitability
shall be provided.
● Option 3: Active Pharmaceutical Ingredient
Master File (APIMF)

can be used to screen
is responsible for protecting the public health
potential variables for DOE studies to

by ensuring the safety, efficacy, and security of
minimize the total number of experiments

human and veterinary drugs, biological
conducted while maximizing knowledge

products, and medical devices; and by ensuring
gained. the safety of our nation's food supply,
Definition 50 of 64
pan coating
Definition 54 of 64
gas suspension
is defined as the collection and evaluation of
vacuum film coating

data, from the process design stage through
dip coating
commercial production, which establishes
electrostatic coating scientific evidence that a process is capable
of consistently delivering a quality product.
Definition 51 of 64
A written protocol that specifies the
Definition 55 of 64
manufacturing conditions, controls, testing,

a means of ensuring that manufacturing
and expected outcomes is essential for this

processes are capable of consistently
stage of process validation producing a finished product of the required
quality. It involves providing documentary
evidence that key steps in the manufacturing
process are consistent and reproducible

Definition 52 of 64
a. Valid License to Operate (LTO)
b. Valid Foreign GMP Clearance
c. Valid Certificate of Pharmaceutical

Definition 56 of 64
Product (CPP)
● For the execution of the manufacturing
d. Valid agreement between the

process validation, the batch formula of the
manufacturer, trader, importer,

solid oral dosage has to be well defined.
distributor

establishing by objective evidence that the
(1) For the introduction of New Products in
process , under anticipated conditions,

the manufacturing facility.
consistently produces a product which meets all

(2) If there is a significant change in the
predetermined requirements. manufacturing process and the impact
of the changes, (e.g., leak test failed
due to sealing problems in blister).
(3) Minimum of the first three consecutive
production scale batches after process
Definition 58 of 64
stabilization shall consider this
Defining the commercial
validation
manufacturing process based on knowledge
gained through development and scale-up
activities.
Definition 62 of 64
(1) Design of the facility and qualification of the
Definition 59 of 64
equipment and utilities
● the activity of defining the commercial

(2) Process performance qualification (PPQ)
manufacturing process that will be reflected in

(3) PPQ Protocol
planned master production and control

(4) PPQ Protocol Execution and Report
records
● GOAL: to design a process suitable for routine
commercial manufacturing that can
consistently deliver a product that meets its

Definition 63 of 64
quality attributes convective mixers
A condition in which the set

The collection and
of controls consistently provides assurance of

evaluation of data, from the process design
continued process performance and product

stage through commercial production, which
quality. establishes scientific evidence that a process is
capable of consistently delivering quality
products.

Test - Manuf Lab - Quizlet

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Test - Manuf Lab - Quizlet

Uploaded by

Copyright:

Available Formats

12/6/22, 12:15 AM Test: MANUF LAB | Quizlet 12/6/22, 12:15 AM Test: MANUF LAB | Quizlet

Name: Score: Definition 4 of 64

Definition 1 of 64 ○ Dissolution Time

manufacturing process resulting in

commercial product. For the purposes of this guidance, the

term commercial manufacturing process does

not include clinical trial or treatment IND

The degree to which a set of inherent

properties of a product, system, or process

fulfills requirements. clearance or microbial contamination)

○ When intermediates and products

cannot be highly characterized and

1. Duly accomplished and notarized Integrated

2. Letter of Authorization (where applicable)

4. Site Master File

6. Representative Sample with corresponding

Certificate of Analysis (upon request of the

7. Product Information c. Valid agreement between the

manufacturer, trader, distributor

https://quizlet.com/753294644/test?answerTermSides=2&promptTermSides=6&questionCount=64&questionTypes=1&showImages=true 1/16 https://quizlet.com/753294644/test?answerTermSides=2&promptTermSides=6&questionCount=64&questionTypes=1&showImages=true 2/16

to produce a product that will fulfill the

requirements of that product. The concept of

process capability can also be defined in

statistical terms. a. Certificate of Pharmaceutical Product

b. Foreign GMP Clearance

3. For fixed-dose combination: Rationale of the

combines the actual facility, utilities,

equipment (each now qualified), and the

manufacturing process, control procedures,

and components to produce commercial

quality of the product.

b. GMP certificate of the manufacturer

c. Copy of "under-license" agreement is based on historical and testing data of

previously manufactured batches. It includes

trends analysis complied and the extent to

which the process is within the permissible

Definition 10 of 64 range of the process parameters.

validation studies to be conducted on the production

Definition 11 of 64 pneumatic blender

in ICH member countries / regions

https://quizlet.com/753294644/test?answerTermSides=2&promptTermSides=6&questionCount=64&questionTypes=1&showImages=true 3/16 https://quizlet.com/753294644/test?answerTermSides=2&promptTermSides=6&questionCount=64&questionTypes=1&showImages=true 4/16

remains in a state of control (the validated

● Carried out during the development stage

● Also called pre-market validation

suitable for their intended use and perform

properly. These activities necessarily precede

manufacturing products at the commercial

objective evidence that all key aspects of the

process equipment and ancillary system

installation adhere to the manufacturer's

Definition 19 of 64 approved specification and that the

● The major equipment, used for the

manufacturing process, are to be identified

● The equipment are broadly categorized by the

defined during this stage based on knowledge

gained through development and scale-up

https://quizlet.com/753294644/test?answerTermSides=2&promptTermSides=6&questionCount=64&questionTypes=1&showImages=true 5/16 https://quizlet.com/753294644/test?answerTermSides=2&promptTermSides=6&questionCount=64&questionTypes=1&showImages=true 6/16

production that the process remains in a state

of control. and juridical person engaged in manufacture,

distribution, importation, exportation, sale,

offer for sale, testing and transfer of the

equipment monitoring at significant