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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, 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 

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