Unit III
Unit III
Unit III
Learning outcomes
➢ Students learnt about the quality assurance and quality control parameters which affects
academics as well as pharmaceutical industry.
➢ Students learnt about the good laboratory practices in association with equipment
documentation, testing facilities operation and records.
Structure of Module -3BP 606T
Learning Material
Quality Control- Quality control test for containers, rubber closures and secondary packing materials.
Good Laboratory Practices- General Provisions, Organization and Personnel, Facilities, Equipment,
Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical
Laboratory Study, Records and Reports, Disqualification of Testing Facilities.
GOOD
LABORATORY
PRACTICES
GLP: GOOD LABORATORY PRACTICE
Pharmaceuticals
Pesticides
Food and feed additives
Cosmetic products
Veterinary drug products and similar products
Industrial chemicals
Objectives of GLP
True reflection
Ensure Honesty International acceptance
GLP makes sure Promotes
that the data GLP also makes internation
submitted are a sure that not to al
true reflection of indulge in any acceptance
the results that are fraud activity by of tests
obtained during labs
the study.
Protocols of GLP
Ensure sufficient number of qualified personnel, appropriate
facilities, equipment, and materials
Waste Disposal
Apparatus to be
Apparatus, including periodically inspected,
validated computerised cleaned, maintained,
systems should be of and calibrated
appropriate design & according to Standard
adequate capacity Operating Procedures.
Chemicals, reagents
and solutions should Should not
be labelled to indicate interfere adversely
identity, DOE & with the test
storage instructions systems.
5. Test Systems
Physical/ Chemical
Biological
6. Test and Reference Items
Production marketing
Role of Packaging:
Presentation
Identification
Information
Convenience
Primary packaging
Primary Packaging is the material that first envelops the product and holds it. This
usually is the smallest unit of distribution or use and is the package which is in direct
contact with the contents.
Secondary Packaging
Secondary Packaging is outside the primary packaging perhaps used to group
primary packages together
Tertiary Packaging
Tertiary Packaging is used for bulk handling , warehouse storage and
transport shipping.
◦ Ampoules
◦ Vials
◦ Containers
◦ Dosing dropper
◦ Syringe
◦ Strip package
◦ Blister packaging
• Paper and boards
• Cartons
• Box manufacture
TYPES OF GLASS:
1) Type I ( Neutral or Borosilicate Glass)
Type I
Type II /III
QUALITY CONTROL TESTS FOR GLASSES
1) CHEMICAL RESISTANT OF GLASS CONTAINERS
A) Powdered Glass Test:
It is done to estimate the amount of alkali leached from the powdered glass which
usually happens at the elevated temperatures. When the glass is powdered, leaching of alkali
is enhanced, which can be titrated with 0.02N sulphuric acid using methyl red as an indicator
Procedure:
Rinse thoroughly with high purity water.
Fill each container to 90% of its overflow capacity with water and is autoclaved at 121⁰C for
30min then it is cooled and the liquid is decanted which is titrated with 0.02N sulphuric acid
using methyl red as an indicator.
The volume of sulfuric acid consumed is the measure of the amount of alkaline oxides
present in the glass containers.
Test Limits
Type I 1.0
Powdered glass test Type II 8.5
Type III 15.0
Remove the container from autoclave, cool and combine the liquids being examined.
Measure the volume of test solution into a conical flask and titrate with 0.01M HCl using
methyl red as an indicator. Perform blank with water and the difference between the titration
represents the volume of HCl consumed by the test solution.
04 Leakage Test:
Fill 10 containers with water, fit with intended closures and keep them inverted at
room temperature for 24hr.The test is said to be passed if there is no signs of leakage
from any container.
The most common instrument used is American glass research increment
pressure tester .The test bottle is filled with water and placed inside the test
chamber. A scaling head is applied and the internal pressure automatically raised by
a series of increments each of which is held for a set of time. The bottle can be
checked to a preselected pressure level and the test continues until the container
finally bursts.
Collapsibility test :
Applicable to containers which are to be squeezed in order to
remove contents. yield 90%of its contents at required rate of flow at ambient
temp.
Non-volatile residue
Evaporate 100 ml of the extract obtained in the test for Clarity of
aqueous extract to dryness and dry to constant weight at 105º. The residue weighs not
more than 12.5 mg.
Leakage test, Collapsibility test
Same As Describe in Non- Injectable
Acidity or alkalinity.
To a volume of solution S corresponding to 4 per cent of the nominal
capacity of the container add 0.1 ml of phenolphthalein solution. The solution is
colorless. Add 0.4 ml of 0.01M sodium hydroxide. The solution is pink. Add 0.8 ml
of 0.01M hydrochloric acid and 0.1 ml of methyl red solution. The solution is
orange-red or red.
Light absorption.
The light absorption in the range 230 nm to 360 nm of solution S using a blank
prepared as described under Solution S is not more than 0.20
Reducing substances.
To 20.0 ml of solution S add 1 ml of dilute sulphuric acid and 20.0 ml of
0.002M potassium permanganate. Boil for 3 minutes. Cool immediately. Add 1 g of
potassium iodide and titrate immediately with 0.01M sodium thiosulphate, using 0.25
ml of starch solution as indicator. Carry out a titration using 20.0 ml of the blank
prepared as described under Solution S. The difference between the titration volumes
is not more than 1.5 ml.
Transparency
Fill the container previously used for the preparation of solution S to its
nominal capacity with a 1 in 200 dilution of the standard suspension for
a container made from polyethylene or polypropylene. For containers of
other materials, use a 1 in 400 dilution. The cloudiness of the
suspension is perceptible when viewed through the container and
compared with a similar container filled with water
Fill 5 containers with nominal volume of water and heat seal the bottles with
aluminium foil.
Weigh accurately each container and allow to stand for 14 days humidity-
60±5% temp. 20Ċ and 25Ċ.