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Unit 3

The document discusses quality control tests that are performed on packaging materials and containers used for pharmaceutical products. It describes different types of primary and secondary packaging materials as well as various tests conducted on plastic containers, glass containers, closures and packaging to ensure quality. The document also provides an overview of Good Laboratory Practices (GLP) including its purpose and key elements such as organization and personnel, facilities, conducting studies and maintaining records.

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Abhishek Sharma
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172 views

Unit 3

The document discusses quality control tests that are performed on packaging materials and containers used for pharmaceutical products. It describes different types of primary and secondary packaging materials as well as various tests conducted on plastic containers, glass containers, closures and packaging to ensure quality. The document also provides an overview of Good Laboratory Practices (GLP) including its purpose and key elements such as organization and personnel, facilities, conducting studies and maintaining records.

Uploaded by

Abhishek Sharma
Copyright
© © All Rights Reserved
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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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.

They come in direct contact with the product material.


Primary Packaging Material Eg: Bottles, vials, tins, blisters etc…

Secondary Packaging They are used to cover primary packs.


Material Eg: cartons, cardboards…

Composition of Package: Container, Closure, Carton or outer and box.


TESTS ON PLASTIC CONTAINERS
FOR BOTH PARENTERAL AND NON-PARENTERAL PREPARATIONS

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

Used to test the limit of alkalinity liberated


by glass.
ARSENIC TEST
THERMAL SHOCK TEST
INTERNAL BURSTING PRESSURE TEST
closures

CLOSURES are the most vulnerable and critical component of a


container as far as stability and compatibility with product is
concerned.

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

I. Disqualification of Testing Facilities Purpose.


GLP Sub Part A
• General Provisions describing GLP practices for conducting non
clinical laboratory studies that support or are intended to support
applications for research or marketing permits for products regulated
by FDA. (It included food, color additives, animal food additives,
human and animal drugs, medical devices for human use, biological
products and electronic products)
• Inspection of the testing facility.

In vivo or in vitro experiments in which test articles are studied


laboratory study

prospectively in test systems under laboratory conditions to


Non clinical

determine their safety.

**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

To prevent contamination and mix ups, there shall be separate


areas for:
1.Receipt and storage of test and control articles.
2.Mixing of the test and control articles with a carrier.
3.Storage of test and control articles.
EQUIPMENT
TESTING FACILITIES OPERATION.

1. Separate laboratory Operation areas shall be provided for the


performance of the routine and specialized procedures
required by non- clinical laboratory studies.
2. SOPs
3. Reagents and solutions
4. Animal care.
Sub Part G
GLP PROTOCOL for and CONDUCT OF
NON CLINICAL LABORATORY STUDY
PROTOCOL Each study will have an approved written protocol, clearly
indicating objectives and methods for conduct of the study
Sub Part H
GLP RECORDS AND REPORTS
REPORTING OF NON CLINICAL LABORATORY STUDY RESULTS
1. Name and address of the facility performing the study.
2. Date of initiation and completion.
3. Objectives and procedures stated in approved protocol, including any changes in the original protocol.
4. Statistical methods employed for analyzing the data.
5. Description of materials and test methods.
6. The test and control articles identified by name, chemical abstracts number or code number, strength,
purity and composition.
7. The locations were all specimens, raw data, and final reports are to be stored.
8. The name of the study director, and other scientists and professionals involved.
9. The statement prepared and signed by QA unit
10.Final report shall be signed and dated by the study director
11.Corrections and additions to final report shall be in the form of amendment by SD.
RECORDS, SPECIMENS, AND RAW DATA of non clinical laboratory studies shall be
retained in the archive s section for whichever of the following period is shortest.

1. A period of 2 years following the date on which an application for research or


marketing permit, in support of which the results have been submitted, is
approved by FDA. This clause is exempted for studies supporting INDAs and IDE
2. A period of atleast 5 years following the date on which the results of the non
clinical laboratory studies are submitted to FDA in support of an application for a
research or marketing permit.
3. In other situations, a period of atleast 2 years following the date on which the
study is completed, terminated, or discontinued.
Sub Part I
GLP DISQUALIFICATION OF TESTING
FACILITIES

(a) The purposes of disqualification are:


(1) To permit the exclusion from consideration of completed studies that were conducted by a testing facility which
has failed to comply with the requirements of the good laboratory practice regulations until it can be adequately
demonstrated that such noncompliance did not occur during, or did not affect the validity or acceptability of data
generated by, a particular study; and
(2) To exclude from consideration all studies completed after the date of disqualification until the facility can satisfy
the Commissioner that it will conduct studies in compliance with such regulations.

(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.

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