Presented By: Samiksha B.Sawant M, PHARM (IP), 1 SEM Guided By: Dr. Indira Parab
Presented By: Samiksha B.Sawant M, PHARM (IP), 1 SEM Guided By: Dr. Indira Parab
Presented By: Samiksha B.Sawant M, PHARM (IP), 1 SEM Guided By: Dr. Indira Parab
SAMIKSHA B.SAWANT
M,PHARM (IP), 1ST SEM
GUIDED BY:
DR. INDIRA PARAB
“QUALITY IS NOT AN
ACCIDENT; BUT IT IS THE
RESULT OF INTELLIGENT
EFFORTS”
WHAT IS QUALITY?
“Quality is fitness for use. ”
QUALITY
FEEDBACK OF
DETERMINATION THIS DEFECT
OF CAUSE OF TO
DEFECT APPROPRIATE
PERSON
QC THROUGHOUT PRODUCTION
SYSTEM
INPUTS CONVERSION OUTPUTS
CONTROL CONTROL
CHARTS AND CONTROL CHARTS AND
ACCEPTANCE CHARTS ACCEPTANCE
PLANS PLANS
QUALITY OF QUALITY OF QUALITY OF
INPUTS PARTIALLY OUTPUTS
PROCESSED
PRODUCTS
PRE-PRODUCTION QC
INSPECTION
The safety and efficacy of the finished dosage form
is largely dependent on the purity and quality of the
bulk active drug substance.
Acceptance sampling
CONTROL CHARTS
Primary purpose of control charts is to indicate
when production processes might have changed
sufficiently to affect product quality.
If the indication is that product quality has
deteriorated, corrective is taken.
Compare attributes (No. of defectives in a
sample)or variables (characteristics that can be
measured on a continuous scale (weight, length,
etc.) of the sample with that of the standard
ACCEPTANCE SAMPLING OR SAMPLING INSPECTION
It is the process of evaluating portion of the product
material in a lot for the purpose of accepting or
rejecting the lot as either conforming or not
conforming to quality specifications.
The acceptance plan identifies the:
Size of samples, n
Type of samples
Decision criterion, c, used to either accept or
reject the lot
Samples may be either single, double, or sequential.
SINGLE SAMPLING PLAN
Draw random sample (n) from the lot
Special storage:
Availability of cold room/refrigerator for vaccines
and biological products