PRESENTATION IS EXCLUSIVELY FOR B.PHARM VI SEMESTER STUDENT FOR THE SUBJECT QUALITY ASSURANCE, AS PER PCI SYLLABUS.

1. QUALITY ASSURANCE AND
QUALITY MANGEMENT SYSTEM
AND
TOTAL QUALITY
MANAGEMENT(TQM)
BY
DIPANKAR NATH.
ASSISTANT PROFESSOR.
DEPARTMENT OF PHARMACEUTICAL ANALYSIS
HIMALAYAN PHARMACY INSTITUTE.

85.  Since its inception in 1990 ,ICH has gradually evolved to respond to the increasing global
face of drug development.
 The International Council for Harmonization(ICH) formerly the International conference on
Harmonization(ICH) held the inaugural assembly meeting on 23rd October 2015
establishing ICH as an international association a legal entity under Swiss law.

89. PROCESS OF HARMONISATION:

90. CATEGORIES OF ICH TOPICS:
ICH topics are divided in to four categories:
Q-Quality Guidelines (Stability, Impurities Testing, GMP)
S-Safety Guidelines (Carcinogenicity,Genotoxicity,Reprotoxicity)
E-Efficacy Guidelines (Clinical trials, Pharmacogenomics)
M-Multidisciplinary Guidelines(MedDRA, CTD, ESTRI)

111. SOME IMPORTANT TERMS:
ACCELERATED TESTING: Studies designed to increase the rate of chemical degradation or
Physical Change of a drug substance or drug product by using exaggerated storage conditions
as part of the formal stability studies .
CLIMATIC ZONES: The four
zones in the world that are
distinguished by their
characteristic prevalent annual
climatic conditions.

112. IMPERMEABLE CONTAINERS : Containers that provide a permanent barrier to the passage
of gases or solvents,e.g. sealed aluminum tubes for semi solids, sealed glass ampoules for
solutions.
INTERMEDIATE TESTING: Studies conducted at 300C/65% RH and designed to moderately
increase the rate of chemical degradation or physical changes for a drug substance or drug
product intended to be stored for long term at 250C.
LONG TERM TESTING: Stability studies under recommended storage condition for the retest
period or shelf life proposed/ approved for labelling.
FORMAL STABILITY STUDIES: Long term and accelerated(and intermediate) studies
undertaken on primary and/or commitment batches according to prescribed stability protocol
to establish or confirm the retest period of a drug substance or the shelf life of a drug product.

113. BRACKETING: Bracketing is the design of a stability schedule such that only samples on the
extremes of certain design factors (e.g. strength, container size etc.) are tested at all time points
as in full design. The design assumes that the stability of any intermediate levels is represented
by the stability of the extremes tested.
MATRIXING: Matrixing is the design of a stability schedule such that a selected subset of the
total number of possible samples for all factor combinations would be tested at a specified
time point .At a subsequent time point another subset of samples for all factor combinations
would be tested .The design assumes that the stability of each subset of samples tested
represents the stability of all samples at a given time point.
FULL STUDY DESIGN: A full study design is one in which samples for every combination
of all design factors are tested at all time points.
.

114. REDUCED DESIGN: A Reduced design is one in which samples for every factor combination
are not all tested at all time points
NEW MOLECULAR ENTITY: An active pharmaceutical substance not previously contained
in any drug product registered with the national or regional authority concerned. It may be a
new salt, ester, or non covalent bond derivative of an already approved drug substance.
PILOT SCALE BATCH: A batch of a drug substance or drug product manufactured by a
procedure fully representative of and simulating that to be applied to a full production scale
batch. For solid oral dosage forms, a pilot scale is generally at minimum one tenth that of a full
production scale or 100000 tablets or capsules, whichever is larger.