UNIT OF RESPONSIBILITY :- QA Executive and trained QA Assistants
IMPORTANT POINT/ NOTE/ PRECAUTIONS : –
1 Ensure the complete cleanliness of the microscope eyepiece and the objective before its use
2 Handle the Instruement carefully
PROCEDURE :-
1 Calibrate the eye piece micrometer scale by aligning with the stage micrometer (graduated in 10 u increment) under 10 X magnification so that they are parellel
2 Spread evenly over the cleaned microscopic slide, the material or the powder to be tested for particle size
Add a drop of liquid paraffin over it in case of powder to be tested and prepare the smear In case of finished product spread the material over the microscopic slide and cover with cover slip to prepare the smear
3 Adjust the microscope in such a way that the particles are clearly visible
4 Count about 100 particles
5 Record the count as per the limits specified in the individual monograph
6 Record the count as per the observations in the attachment No 1
OTHER RELEVANT DETAILS :
1 Limits as specified in the individual monograph
PERSONNEL TO BE REPORTED IN CASE OF NON COMPLIANCE :- Department Head
FREQUENCY OF OPERATION :- For every lot of raw material as well as finished product
NO OF ATTACHMENTS :- NOs
RETENTION OF RECORDS :- 5 Years
=============================================
This website is a guide for Pharmaceutical Manufacturing
Following are some of articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing
Guidelines on Pharmaceutical Manufacturing Pharma Quality Assurance Quality Management System 
Leave a Reply