Follow Our FB Page << CircleMedia.in >> for Daily Laughter. We Post Funny, Viral, Comedy Videos, Memes, Vines...


What is the process validation?



What is the process validation?..

Answer / navinpatel

As per USFDA,Process validation is defined as the collection
and evaluation of data, from the process design stage
through commercial production, which establishes scientific
evidence that a process is capable of consistently
delivering quality product. Process validation involves a
series of activities taking place over the lifecycle of the
product and process.

The guidance documents describes process validation
activities in three stages:

Stage 1 – Process Design
Stage 2 – Process Qualification
Stage 3 – Continued Process Verification

For more information please refer: Guidance for Industry:
Process Validation: General Principles and Practices,
January 2011

Is This Answer Correct ?    7 Yes 0 No

Post New Answer

More Pharmacy Interview Questions

What is the difference between mix-up and cross-contamination?

2 Answers  


define the starting material?

0 Answers  


why some samples are taking 500mg for water content and some samples are taken 2g for water content?

1 Answers   Natco,


how you can fix the known and unknown impurity limit for any drug substance

0 Answers  


DEFINITION OF STABILITY INDICATING METHOD

8 Answers   Reddy Labs,






If a drug possesses zwitter ionic nature then can it plays any important role in pharmacy?

3 Answers   Cipla, Orion Laboratories,


When we change water of Hygrometer?

0 Answers   APL,


plzzz mail me question papers and syllabus of mpsc's and upsc's drug inspector's exam.and details whn da exm is going to be.. my e-mail id is shubhg_2007@yahoo.com.thanx..

0 Answers  


Coaching Class/Study Materials for Drugs Inspector In Chennai Classes Giong to start.Hi I Joined,I am giving the details If u find it useful then use the oppurtuinty.One Seminar I attended there and the Faculties were good so I joined. They also said they will provide the materials of class at a nominal rate. INDIAN IAS ACADEMY Annanagar West,Chennai. Contact 9841996486. Two maonths all Saturdays and Sundays.

2 Answers  


What will be in case stability sampleWhich have batch but distribute in three country.In tath case< we can put the sample for all country, whenevr all have same temp(Zone)

5 Answers   Cipla, Wipro,


What is NOEL?

1 Answers  


what is difference between method validation and method verification

1 Answers  






Categories