Custom Search

Tuesday, August 11, 2009

MICROSCOPE PARTICLE SIZE DETERMINATION RAW MATERIAL FINISHED PRODUCTS

OBJECTIVE :- To determine the particle size of the raw material that is used as the active ingredients in pharmaceutical product and also the finished product microscopically


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

Pharmaceutical Validation

Cleen Room Classification

Pharmaceutical Industry

Pharmaceutical Manufacturing

Clinical Trials

Media fill

Pharmaceutical companies

Regulatory Affairs in Pharmaceutical Industry


Determination of Phenol coeeficient of a disinfectant

No comments:

Posted by: Martin

How to sucessfuly activate and receive our articles on pharmaceuticals by E-Mail

Dear readers if you wish to receive our articles on pharmaceutical automatically into your email Inbox , as and when we write a new article over this website, then follow these 3 simple steps.


1.You should write your Email ID in the box provided and push the subscribe butten


2.Enter the text code that we show you in a small new browser window after you enter your email ID.

3.Log in to your email and Cheke our verification email sent by "FEEDBURNER" , there you should verify the link we send you by email.




Enter your email address get our articles by email whenever this website is updated





Delivered by FeedBurner



Join the list of our readers from Universities ,Research and Development centers Pharmaceutical Companies from all over the world.











Pharma Research Regulatory Guidelines Website
Texas Dallas, TX 75211 US
Email: editor@pharmacistspharmajournal.org Website: http://pharmacistspharmajournal.org/
Copyright © 2008-2015 all rights reserve www.pharmacistspharmajournal.org