Standard Operating Procedure for Grittiness Test for Cream & Ointment

Grittiness Test for Cream & Ointment

1.0 OBJECTIVE

To lay down the procedure for the grittiness for the cream / ointment.

2.0       SCOPE

This procedure is applicable to all stages of bulk & binished products.

3.0 RESPONSIBILITIES

QC Executive/Officer/designee shall be responsible for follow the SOP.

Head-QC/Designee shall be responsible for the ensuring overall compliance of the Standard Operating Procedure.

4.0 DISTRIBUTION

Master copy    : Quality Assurance Department

Controlled copy – 1     : Quality Control Department

5.0 PROCEDURE   

  • Use two flat clean glass slides that form perfect occlusion.
  • Place about 100 to 200mg of the cream / ointment on one slide.
  • Place the other slide on the first slide with the cream / ointment in-between.
  • Make the slides occlude leaving a thin film of the cream / ointment enabling the light to penetrate the content of the film, thereby displaying its content.
  • Check for the presence of any grit in the cream / ointment film, which is in the form of solid particles.
  • The film should be free from GRIT. If found any grittiness inform to QC Manager / Designee to take necessary action.
  • Document the result on “Test for Grittiness of Cream / Ointment Report” .
  • Document the test result in the respective logbook.

6.0       ABBREVIATIONS

QC      – Quality Control

SOP    – Standard operating procedure

No.      – Number

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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