SOP for Preparation and Control of Protocol for Working Standard

OBJECTIVE

To define the procedure for the preparation and control of the working standard protocol.

SCOPE

This procedure is applicable for preparation and control of the protocol for the working standard.

RESPONSIBILITY

Doing: Tech. Asst/ Executive

Checking: Executive /Manager

ACCOUNTABILITY:

Head of the department.

PROCEDURE

• Refer respective method of analysis.
• Prepare the front page of Protocol as per Annexure – I.
• Prepare the COA of the Working standard as per Annexure – II.
• Prepare the summary report as per Annexure – III.

• Prepare an individual test report as per Annexure – IV for various tests done for the preparation of the Working standard.
• Mention details of each test in the Protocol.
• HPLC and GC test reports are also part ofthe  Protocol.
• Take a Xerox copy of the Protocol for use.
• Maintain issue record with details as per Annexure V.
• Fill the Document History card as per Annexure – VI.
• Stamp the old version of the Protocol as “SUPERSEDED” with Red ink on each page.
• Preserve the “SUPERSEDED” copy of the protocol in a separate file for five years from the effective date.

ABBREVIATION

A.R. No. = Analytical report number

P.M. = Packaging material

MOA = Method of analysis

HPLC = High-performance liquid chromatography.

GC = Gas Chromatography.

W.std. = Working standard.

ANNEXURE

REVISION HISTORY

Nil

ALSO READ: SOP for Handling of Reference Standards, In-House Standards, Primary Standards and Calibration Standards