SOP for Good Documentation Practice

OBJECTIVE

To provide a documented procedure for good documentation practices.

SCOPE

This procedure is applicable for good documentation practices to be followed at the quality control laboratory.

RESPONSIBILITY

Primary: Chemist-Quality Control department.

Overall: Manager Quality control department

PROCEDURE

• All information related to activities should be recorded clearly and easy to read.
• Abbreviated dates should be recorded in the format, Day/Month /Year.
• All documents should be made in blue ball pen only.

• Data should be specific and as far as possible numerical value.
• Scrap paper should not be used for recording the data.
• Documents should be made online.
• If any error is found immediately after recording the data, cross out incorrect information with a single line and not by using erasable pens or Corrective fluids. Enter correct data, sign and write the date near the correction.
• Information should be recorded on proper forms, laboratory notebooks, and cleaning records, immediately after actions are completed. Entries of signatures or initials and dates must be made at the same time.
• Overwrite is not acceptable in any document.

ABBREVIATIONS

Nil

ANNEXURE

Nil

REVISION HISTORY

Nil

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