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| Group PH400 - Consists of PH40, PH41, PH42, PH43, PH44, PH45, PH46, PH47 and PH48 |
| $825.00 |
Qty. |
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PH40 - CALIBRATION AND PREVENTIVE MAINTENANCE
To describe
the procedures for ensuring that inspection, measuring,
test and process equipment are routinely calibrated,
inspected, checked, and maintained to ensure fitness for use. |
| $189.00 |
Qty. |
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PH41 - BUILDING/FACILITY SANITIZATION
To describe the
general procedures for cleaning and sanitizing buildings
and facilities used in the manufacture, processing, packaging
or holding of the product in order to control and
prevent product contamination. |
| $189.00 |
Qty. |
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PH42 - PEST CONTROL PROGRAM
To describe the procedures for
use of suitable rodenticides, insecticides, fungicides or fumigating
agents to prevent pest infestations of facilities used in
the manufacture, processing, packaging and holding of the product. |
| $189.00 |
Qty. |
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PH43 - EQUIPMENT CLEANING AND MAINTENANCE
To describe
the general procedures for cleaning and maintenance
of equipment used in the manufacture, processing, packaging
and holding of the product. |
| $189.00 |
Qty. |
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PH44 - CHARGE IN OF COMPONENTS
To describe procedures
to establish production records with control on accurate
addition and documentation of the labeled or established
amount of controlled materials in a production batch of a
drug product. |
| $189.00 |
Qty. |
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PH45 - COMPONENT HANDLING AND SAMPLING
To describe
procedures for receipt, inspection, segregation, sampling and
disposition of controlled materials. |
| $189.00 |
Qty. |
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PH46 - VALIDATION POLICY
To
describe and document the policies and procedures for
validation activities related to facilities, utilities, processes,
test methods and equipment which directly or indirectly
affect manufacture of the product. (This procedure does not
cover GMP software validation.) |
| $189.00 |
Qty. |
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PH47 - FINISHED PRODUCT RELEASE
To describe the procedures
to assure that all finished products are tested and released for
distribution only after verification of conformance to all applicable
manufacturing, quality, and regulatory requirements. |
| $189.00 |
Qty. |
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PH48 - SOFTWARE VALIDATION
To describe software validation
activities to ensure that software complies with established software requirements and satisfies its intended use. |
| $189.00 |
Qty. |
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