Unit 3
Unit 3
QUALITY CONTROL
&
GOOD LABORATORY PRACTICES
Quality control test for containers,
Packaging is a process by which the pharmaceuticals are suitably packed
so that they should retain their therapeutic effectiveness from the time of
packaging till they are consumed.
LEAKAGE TEST
COLLAPSIBILITY TEST
CLARITY OF AQUEOUS EXTRACT
TRANSPARENCY TEST
Fill 5 empty containers to their normal capacity with diluted suspensions. (IP 1966)
The cloudiness of the diluted suspension in each container is detectable when viewed
through the containers as compared with a container of the same type filled with
water.
WATER VAPOUR PERMEABILTY TEST
TESTS ON GLASS CONTAINERS
GLASS GENERAL TEST USES LIMITS
TYPES DESCRIPTION METHOD (Vol ml of
0.02N)
TYPE I HIGHLY RESISTANT POWDERED TEST For buffered and unbuffered 1.0
BOROSILICATE GLASS aqueous solutions, powders
TYPE II Treated (Sulphur WATER ATTACK For buffered aqueous solution 0.7 or 0.2
dioxide fumes) SODA TEST with pH below 7 and for dry
LIME GLASS powders
TYPE III SODA LIME GLASS POWDERED TEST For dry powders and 8.5
oleaginous solutions, not for
aqueous preparations
TYPE IV GENERAL PURPOSE POWDERED TEST Not for parenterals and for 15.0
SODA LIME GLASS suspension and emulsion.
POWDERED
GLASS
TEST
WATER
ATTACK
TEST
HYDROLYTIC
RESISTANCE OF GLASS
CONTAINERS
TYPES OF CLOSURES
• Thread screw cap
• Lug cap
• Crown Cap
• Pilfer proof closures
Materials used for making closures
• Cork
• Glass
• Rubber
• Plastic
• Metal
Quality control test for closures
RESIDUE ON EVAPORATION
• 50ml of Solution A is evaporated to dryness on a water bath and dried
at 105°C.
• The residue weighs not more than 4 mg.
STERILIZATION TEST
The closures used for the preparation of the sample solution shall not
soften or become tacky and there shall be no visual change in the
closure.
pH of AQUEOUS EXTRACT
SELF STABILITY TEST
GOOD LABORATORY
PRACTICES
GLP deals with the organization, process and
conditions under which laboratory studies are
planned, performed monitored, recorded and
reported. GLP practices are intended to promote the
quality and validity of test data.
WHY WAS GLP CREATED ?
GOOD LABORATORY PRACTICES includes
**The term does not include basic exploratory studies carried out to determine physical or
chemical characteristics of test article and does not include studies utilizing human
GLP Sub Part B
ORGANIZATION AND PERSONNEL
ORGANIZATION Functions
of non -
GLP Sub Part C
FACILITIES
ANIMAL CARE FACILITIES
FACILITIES FOR HANDLING TEST AND CONTROL
ARTICLES
(b) The determination that a nonclinical laboratory study may not be considered in support of an application for a
research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any
other applicable regulation to submit the results of the study to the Food and Drug Administration.
Grounds for disqualification.
The Commissioner may disqualify a testing facility upon finding all of the following:
(a) The testing facility failed to comply with one or more of the regulations set forth in this
part (or any other regulations regarding such facilities in this chapter);
(b) The noncompliance adversely affected the validity of the nonclinical laboratory studies;
and
(c) Other lesser regulatory actions (e.g., warnings or rejection of individual studies) have not
been or will probably not be adequate to achieve compliance with the good laboratory
practice regulations.