Professional Documents
Culture Documents
By T i t l e Signed Date
Prepared
Approved
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Contents :
1. Objective.
2. Scope.
3. Responsibilities.
3.1. Validation team.
3.2. Main specific duties.
3.3. Approval.
4. Proceeding.
4.1. Documentation.
4.2. Equipment qualification and calibration.
4.3. Procedure.
5. Documentation.
6. Valid Regulation.
7. Attachment.
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1.0. O b j e c t i v e
1.2. To provide evidence that the general system performance i.e. verification of the
wavelength and photometric scales as well as accuracy, precision and linearity are
satisfactory.
1.3. To ensure that procedure remains suitable for its intended purpose to provide
reliable test results at all times.
2.0. S c o p e
2.1. This protocol is used as the official validation protocol to verify that the assay
method is suitable for use in the laboratory.
2.2.2. Precision
2.2. To be performed for new assay or current assay when any changes are made to the
procedure i.e. changes in the composition of the drug product or change in the
analytical procedure or change in the synthesis of the drug material.
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3.0. Responsibilities
3.2.1. The Team Leader together with the Validation Team are responsible for
overall adherence to this protocol :
1. Scheduling of the validation run in conjunction with appropriate unit
operation or department.
2. Monitoring of protocol completeness and calibration of equipments.
4. Preparation of report.
3.3. Approval
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4.0. Proceeding
4.1. Documentation
4.2.1. The instrument i.e. UV – VIS Spectrophotometer unit used must be calibrated
before validation and the result must within the acceptable limit both for
wavelength scale as well asttachment 1.
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