SOP for Review and Approval of Analytical Raw Data

PURPOSE

This procedure provides instructions for the Review and Approval of Analytical Raw Data.

SCOPE

This procedure applies to all documents relating to pharmaceutical product testing, packaging testing, and raw material testing at PharmaInfo Ltd.

RESPONSIBILITY

QC Officer: to analyze the Raw, Packaging, and finished goods according to specification.

QC Manager:

QC Head and QA Head shall be accountable for the compliance of this SOP.

PROCEDURE

The reviewer shall ensure the following at the time of review of the documents.

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• All the relevant details of the tested material.
• Correct & Current Specification No.
• All the tests are performed as per the required specifications.
• Correct use of working standard and its potency along with WS..No.
• Correct use of HPLC columns.
• All print-out chromatograms duly signed & dated by the Analyst should be attached.
• The raw data shall contain Instrument No, used for the analysis.
• Correct Normality is used.
• Correct units for measurements are mentioned.
• The reviewer shall also ensure the following,
• Rounding off the results is done.
• Correctness of the calculations.
• Justifications for discarding the data ( if any )
• After going through the requirements mentioned earlier, the reviewers shall put their Signature & date on the raw analytical data.

ABBREVIATIONS

QA: Quality Assurance

QC: Quality Control

REVISION HISTORY

Nil

ALSO READ: SOP for Analytical Data Review