Professional Documents
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Global pharmaceutical
Humak, model town ,kahutta road Islamabad Pakistan
5/1/2019 1
Topic: QC Department of Global
Pharmaceuticals
Aatra khan FA15-phm-064
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Quality control department
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QC department layout
QC lab consist of following sections:
• Analytical section
• Micro section
• Packaging section
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Responsibilities:
The basic duties of QC department are:
To give line clearance at various steps either raw material level or production
level prior to start.
To maintain record and documentation.
Other duties are:
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LOG BOOKS
Every equipment or apparatus that is used in laboratory must be
enter into a book that is named as LOG BOOK.
These log books are helpful while performing an ASSAY.
CALIBRATION
Before using any apparatus calibration is performed for every
apparatus in the laboratory before starting work.
Documentation
This process involves different steps but the most important steps
are
•Bulk report
•Filled report
•Finish Goods report
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Qc department and apparatus:
Quality control is a procedure or set of procedures intended to
ensure that a manufactured product or performed service adheres to
a defined set of quality criteria or meets the requirements of the
client or customer, QC is similar to, but not identical with quality
assurance.
INSTRUMENTS IN ANALYTICAL SECTION
1-Analytical Balance:
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3-Dsolutionn Apparatus: 6-Conductivity Meter:
4-Dessicator:
7-High Liquid Chromatography (HPLC):
5-Magnetic Sonnicator:
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8-pH Meter: 10-UV:
9-Polarimeter:
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Microbiology section:
It involves the study of microorganisms associated with the manufacture of
pharmaceuticals. This section is supervised by microbiologist who performs
different tests and checks before during and after production to make the product
sterile.
Water qualification
Sterility test(for 14 days)
Endotoxin test (for 1hour)
Media preparation
Particle liquid counter
Stability studies 5/1/2019
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Packaging section:
In packaging section where I observed QC officer doing following tests on:
Primary materials (Aluminium foil)
Secondary materials (Blister)
Tertiary materials (shipper)
The test performed are:
Physical appearance Flapping
Pasting
Cutting
Dimensions, Length, Width And Height, Diameter (Internal And External)
Grammage
Proof reading
Chemical testing
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