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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 Pharmasky 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 reviewal of the documents.


  • 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 reviewar shall also ensure for the following,
Rounding off the results is done. (SOP for Rounding off of Analytical Test Results)
Correctness of the calculations.
Justifications for discarding the data ( if any )
After going through the above-mentioned requirements, the reviewers shall put his Signature & date on the raw analytical data.

ABBREVIATIONS
QA: Quality Assurance
QC: Quality Control

REVISION HISTORY
Nil


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