Friday, March 21, 2014

Selection of Glass Vial Sterile Injectable product

Selection of Glass compatibility with drug product is major issue in Sterile Pharmaceutical practice. Physical and & Chemical stability is the major issue. Wrong selection of glass type caused breakages during Lyophilization, washing, DHS etc activity.

“ As per 21CFR211.94 Drug product containers and closures:

(a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements.

(b) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.”

Sunday, March 16, 2014

Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 6)

Few basic question ask during interview of fresher candidates (B.pharma /M.pharma) in HR round, so get ready and be prepared for interview 

1.      What is your aim in life?
2.      Who has inspired you in your life and why?

Thursday, March 13, 2014

Qualifying Disinfection for Critical Environments and Cleanrooms

How are Disinfection Qualification Studies Regulated?
The success of disinfection procedures used in an aseptic manufacturing environment and the qualification of such processes to complying with GMP’s are not detailed in a simple guidance document. Although there is no harmonized protocol addressing the regulatory requirements associated with disinfection qualification studies, there are several approaches, principles and methodologies outlined in a variety of published sources. Such sources include USP chapters <1072> and <797>, ISO /DIS 14698-(1-3), ASTM E2614 and FDA’s Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice.

Wednesday, March 5, 2014

Safety is 1st priority

Safety is our main aim.
Don’t think life is a game.
Be alert open your mind-
Don’t be fool and act as blind.
Use proper tool by keep your mind cool,
Never being hurry and never being worry,
Prepare & prevent instead of repair & repent.
Accident Big or Small-
Let them avoid all.
Don’t forget those who are chance taker,
They are the actual accident maker.
Let learn, train & work

 Live life healthy & warm

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