by 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
