Part I (Section 1 - 4) Flashcards
What section states the Authority of CGMP?
Section 1
This order is issued under the authority conferred upon
the________________ by virtue of section 26(a) of RA
3720 as amended
Secretary of Health
A.O no. of GMP
A.O No. 43 S. 1999
What section states the statements of policies?
Section 2
Drugs shall be manufactured using methods,
facilities and control procedures adequate to
preserve their _________, __________, __________, ___________
identity, strength, quality and
purity
Drugs shall be manufactured using _______, ________ and __________ adequate to
preserve their identity, strength, quality and
purity.
methods,
facilities and control procedures
License to manufacture drugs shall be issued
only upon compliance with __________________ guidelines.
Current Good
Manufacturing Practice
________________ is essential to ensure the
manufacture of drugs conforming officially
recognized standards of quality, efficacy and
safety.
Overall control
True or False: The qualities of drug products do not depend on the
starting materials, production, quality control
processes, building, equipment, and personnel
involved and testing protocols
False
What section states the statement of objectives
Section 3
This 1999 GMP guidelines is adopted to:
- Prescribe standard guidelines in the
manufacture of drug products. - Ensure that no person or establishment shall
manufacture drugs under substandard
conditions.
Section 4 states the
Definition of Terms
The nearest value obtained during
measurement or analysis to the true value
Accuracy
The quantity that is actually produced at
any phase of production of a particular drug product
based on the initial input
Actual Yield
Formula of Actual Yield
%AY = (Ay/Ty) x 100
An enclosed space with two or more doors,
which is interposed between two or more rooms
Airlock
Airlock is also termed as
“pass through hatch”
An airlock can also be the ____________ to a clean room in which sterile
goods are handled
“anteroom”
- A supplier of all reliable and of
quality components of finished products generally
approved for use by the trade and accredited by the
manufacturer based on a vendor rating which include
but not limited to conformance to the company or
compendium material specifications
Approved Supplier
A quantity of drug product/device that is
homogenous in character and quality produced during a
given cycle of manufacture and from a specific
manufacturing order.
Batch
True or False: A Batch is heterogenous in character
False.
A designation in numbers or letters or
combination thereof that identifies the batch, and
permits the tracing of the complete history of a batch,
including all stages of its production, control and
distribution
Batch Number
True or False: Batch number includes complete history of a batch including all stages of its production, control and
distribution
True
A contained system, such as a
fermenter, into which biological agents are introduced
together with other materials in order to effect their
multiplication or their production of other substances by
reaction with other materials
Biogenerator
These are
generally equipped with devices for regulation, control
connection, material addition and material withdrawal.
Biogenerator
including genetically engineered microorganisms, cell
cultures, as well as endoparasites, whether pathogenic
or not.
Microbiological Agents
Whole blood collected from a single donor and
processed either for transfusion or further
manufacturing
Blood
Blood donation usually takes __________ or ___________
400-420 mL or <500 mL of blood
True or False: A person can donate blood if he or she weighs less than 50kg
False
Supernatant part of blood (liquid component)
Plasma
Precipitate component of blood
Platelet
Any processed material which has to
undergo another process including packaging operation
to become a finished product.
Bulk Product
The operations carried out to determine
the accuracy of measuring instruments, of “material
measures” such as masses or gauges and of
measurement standards
Calibration
True or False: Calibration can also be used for
measuring instruments without numerical value
False
A system whereby successive
batches of a product manufactured by culture in cells
derived from the same master cell bank
Cell Bank System
This is validated for a
passage level or number of population doubling beyond
that which was achieved during routine production
Cell Bank System
The in-vitro growing of cells isolated from
multicellular organisms.
Cell culture
An area with defined environmental
control of particulate and microbial contamination,
constructed and used in such a way as to minimize the
introduction, generation and retention of contaminants
within the area.
Clean Area
The in-vitro serological tests
performed on donor and recipient blood samples to
establish the serological matching of a donor’s blood or
blood components with that of a potential recipient
Compatibility Testing
- Any material intended to be used for the
manufacture of a product whether raw or packaging
materials.
Component
An area constructed, operated and
equipped with air-handling and filtration system in order
to prevent contamination of the external environment by
biological agents from within the area
Contained Area
Anything that cause contamination to
the product.
Contaminants
An area constructed and operated to
control the introduction of potential contamination
and the consequences of accidental release of living
organisms.
Controlled Area
How should the air supply be in a Controlled Area?
Class III
How is pressure maintained in a Controlled Area?
Negative Pressure
What determines the level of control exercise in a Controlled Area?
The nature of the organism employed in the process
Contaminations of a starting,
intermediate product or finished product.
Cross Contamination
A container designed to store
liquefied gas at extremely low temperature.
Cryogenic Vessel
This is used
for LPG gas
Cryogenic Vessel
A container designed to store gas at a high
pressure. Some examples of this are the oxygen
(green), nitrogen (black), and carbon dioxide tanks that
are usually found in hospitals.
Cylinder
The date indicating the start of
processing of every batch.
Date of Manufacture
The activity of weighing, counting or
measuring and checking of starting materials and
issuing these to the appropriate production personnel;
details of the activity being duly and properly
documented.
Dispensing
Written recording of all procedures,
instructions and processes involved in the manufacture
of drug products
Documentation
This is the official definition of a drug.
Drug Product
T/F: A drug can still be considered a drug product regardless of whether it is in package form
True
Instrument, apparatus, or contrivances,
including their components, parts and accessories,
intended (1) for use in the diagnosis, cure, mitigation, or
prevention of disease in man and animals; or (2) to
affect the structure or any function of the body of man or
animal.
Device
- A date fixed for each individual batch
on or before which the batch is expected to meet the
standard specifications for quality, safety and efficacy.
Expiration Date
Date of manufacture + shelf-life
Expiration date
: Any area used for the collection,
processing, compatibility testing, storage or distribution
of blood and blood components
Blood Products Facilities
This refers to the
building, premises and equipment necessary in the
manufacture of drugs
Other Products Facilities
A product which has undergone all
stages of manufacturing operations.
Finished Product
It is the system
of quality assurance aimed at ensuring that products
are consistently manufactured to a quality appropriate
for their intended use
Good Manufacturing Practice (GMP) -
T/F: GMP is concerned with both
manufacturing and quality control processes and
procedures.
True
- Contaminated with
extraneous biological agents and therefore capable of
spreading infection.
Infected (Man or Animal)
Checks and tests instituted and
carried out in the course of the manufacture of a drug to
assure identity, strength, quality and purity.
In-Process Control
- Any processed substance or
mixture of substances which has to undergo one or
more further stages of processing to become a finished
product
Intermediate Product
- The process in which blood is
extracted from the donor, a leukocyte concentrate is separated, and the remaining formed elements and
residual plasma are returned to the donor
Leukopheresis
T/F: residual plasma can be returned to donor
True
- Gases that, at the specified
temperature and pressure, remain as a liquid in the
cylinder
Liquefied Gases
A batch or any portion of batch produced by a
continuos process, an amount of drugs produced in a
unit of time or quantity in a manner that assures its
uniformity and in either case which is identified by a
distinctive lot number and has uniform character and
quality within specified limits.
Lot
Equipment or apparatus designed to enable
one or more gas containers to be filled simultaneously
from the same source.
Manifold
The complete set of
activities to produce a drug that comprise production
and quality control from dispensing of materials to the
release for distribution of the finished product.
Manufacture or Manufacturing
A culture of fully characterized cells
filled into containers in a single operation, processed
together and stored to ensure uniformity and stability.
Master Cell Bank
Master CEll bank is normally stored at
-70oC or lower
A culture of a microorganism
distributed from a single bulk into containers in a single
operation to ensure uniformity, stability and to prevent
contamination.
Master Seed Lot
The process of packing which is that part
of the production cycle applied to a bulk product to
obtain the finished product
Packaging
consists of materials that
have direct contact with the drug (e.g. foil, tube,
ampules, blisters
Primary packaging
are the boxes, inserts,
labels
Secondary packaging
Any material used in the
packaging of a bulk product to obtain the finished
product.
Packaging Material
The liquid portion
of blood separated and used as material to prepare
another product.
Plasma (for further manufacture)
The process in which blood is
extracted from the donor, the plasma is separated from
the formed elements and at least the red blood cells are
returned to the donor.
Plasmapheresis
The process in which blood is
extracted from the donor, the platelet concentrate is
separated, and the remaining formed elements and
residual plasma are returned to the donor.
Plateletpheresis
The
degree of variation between individual test results when
the method is used separately to different samples
drawn from the same batch of material.
Precision
Types of Precision
Repeatability and Reproducibility
Precision within lab
Repeatability
Precision between lab
Reproducibility
A system of containment that
prevents the dispersal of a biological agent into the
immediate working environment
Primary Containment
It involves the
employment of closed containers or safety biological
cabinets accompanied with secure operating
procedures.
Primary Containment
- Description of the operations to be
executed, the precautions to be implemented directly or
indirectly related to the manufacture of a drug.
Procedures
The part of production cycle starting from
weighing of raw materials to finished product.
Processing
Any process employed after
collection and before computability testing of blood. It
includes the identification of a unit of donor blood, the
preparation of components from such unit of donor
blood, serological testing, labeling and associated
record keeping
Processing of Blood
All operations starting from dispensing of
materials to processing, packaging, to finished product
Production
All control measures taken designed
to ensure that finished products consistently conform to
established specification of identity, strength, purity and
quality
Quality Control
An act of holding off a material for use, or
a product for packaging or distribution by physically setting it apart or by system duly validated, pending a
decision on release or rejection.
Quarantine
- All substances whether active or
excipients that are employed in the processing of a
finished product.
Raw Material -
A resolution between the theoretical
and actual yield. This is performed because of
discrepancies
Reconciliation
This is performed because of
discrepancies
Reconciliation
- The incorporation of all or part of previous
batches with the required quality into another batch at a
defined step of production.
Recovery
The status of materials or products which
are not permitted to be used for processing, packaging
or distribution
Rejected
The status of materials or
products which are permitted to be used for processing,
packaging or distribution
Released or Passed
- A sample representing the
lot, the batch, or the total amount of materials based on
a sampling plan.
Representative Sample
Representative Sample formula
n = (square root of N) + 1
- The reworking of all or part of a batch
of product of an unacceptable quality from a defined
step of production in order that its quality may be
rendered acceptable by one or more additional
operations
Reprocessing
Any finished product which is
already in distribution and sent back to the
manufacturer or distributor due to complaint, damage,
expiration, validity or Page 9 of 92 other reasons such
as the condition of the container or package which may
cast doubt on the product identity, quality, strength and
safety.
Returned Product -
- All measures taken to assure suitable or
adequate environmental conditions in compliance to
GMP.
Sanitation
a
system of containment that prevents the dispersal of a
biological agent into the external environment or into
other working areas.
Secondary Containment
involves the use of rooms with
specially designed air handling, the existence of air
locks and/or sterilizers for the exit of material. It may
add to the effectiveness of primary containment
Secondary Containment -
a system
where successive batches of product are derived from
the same master seed lot at a given passage level.
Seed Lot System
A description of starting
material, intermediate, bulk or finished product in terms
of its chemical, physical and microbiological
characteristics, if any
Specification of Material
Raw materials used in the
production of a finished product (drugs)
Starting Materials -
A room or area of
defined environmental condition with controlled
particulate and microbial contamination, constructed,
equipped and used to eliminate the introduction,
generation or retention of contaminants.
Sterile Room or Sterile Area
- Inactivation or reduction to an acceptable
level of all viable microorganisms by a suitable process.
Sterilization
The quantity that is expected or
planned to be obtained at any phase of production of a
particular product, based on the quantity of components
to be used.
Theoretical Yield -
- The volume of blood or one of its
components in a suitable volume of anticoagulant
obtained from a single collection of blood.
Unit (of Blood)
1 unit is
equivalent to
less than 500mL.
The process of confirming by recognized
appropriate means or manner, that any material,
process, procedure, activity, system, equipment or
mechanics used in production and control consistently
achieved the desired results
Validation
- A culture of cell derived from the
master cell bank and intended for use in the preparation
of production of cell cultures
Working Cell Bank
Working Cell Bank is normally stored at
70OC or lower
A culture of microorganism derived
from the master seed lot and intended for use in
production
Working Seed Lot
A condition or set of conditions
encompassing upper and lower processing limits and
circumstances, within standard operating procedures,
which pose the greatest chance of product or process
failure when, compared to ideal conditions. Such
conditions do not necessarily induce product or process
failure
Worst Case -
