PPR ACT -2015( PHARMACY PRACTICE REGULATIONS)

Pharmacist can open ""Pharma clinic """

Details of ppr act -2015 

i found information on pci.nic.in

And some newspapers

Disclaimer -read details carefully before start i am not responsible for any misconduct or any of case related with this.good luck.

Pharma QA role as third party Audit/visit of plant

1(Q.M.S) -To check to QA system ,QMS how the plant unit complies cGMP & control on operations.
2(Audit compliance) cross check paper work and work on floor.
3.In process control.
4.lab testing cross checks.
5.Review approve or rejects all things related with compliance/noncompliance with cGMP (e.g.production batch records & release of lots./CAPA related issues.)
6.Update management always informed, example system risk 
,reports of regulatory audits and outcomes and ensure responses from QA end completed after complete varification.
Note:: Dont come in pressure remain independent body being as reviewer approver of process.
www.pharmaqaguideline.blogspot.com

DISINTIGRATION TEST APPARATUS OPERATION AND CALIBRATION

(☆)It consists of a basket rack holding six plastic tubes open at the top and bottom. The bottom is covered with a 10 mesh screen. 

(☆)put button on & heat distilled water (800ml) 37±2°C  in 1000ml beaker. Insert 6 tablets in each tube and note d.t. time.The volume of the water should be such that the wire mesh of the moving basket at its highest point is at least 25mm below the surface of the liquid and at its lowest point is atleast 25mm above the bottom of the beaker.

(☆)HEIGHT: Measure the distance between lowest and highest stroke

* limit : 53mm to 57 mm

 (☆)Cycles:Count the number of cycles per minute, 

limit : 28 – 32 cycles/minute.

(☆)CALIBRATION :

Once in a month.

(☆)Take five readings at 15 minutes interval of basket travelling distance and divide average of five readings with 5. 

Limit 53-57mm.

www.pharmaqaguideline.blogspot.com