Skip to content

Pharmaceutical Guidelines

Quality Is Policy

Home
Quality Assurance
SOP
Quality Control
Production
Microbiology
Maintenance
EDQM
Analytical Method Validation
Process Validation
Drug Regulatory Affairs
ICH
cGMP
WHO
Blog
Contact Us
Gallery
Privacy Policy

Tag: USFDA

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II)

October 1, 2018 admin 7 Comments

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II) Out Of Specification( OOS ) :- The all…

Share this:

Click to share on Twitter (Opens in new window)
Click to share on Facebook (Opens in new window)
Click to share on Google+ (Opens in new window)
Click to print (Opens in new window)
Click to share on LinkedIn (Opens in new window)
Click to share on Reddit (Opens in new window)
Click to share on Tumblr (Opens in new window)
Click to share on Pinterest (Opens in new window)
Click to share on Pocket (Opens in new window)
Click to share on Telegram (Opens in new window)
Click to share on WhatsApp (Opens in new window)
Click to share on Skype (Opens in new window)

Continue Reading →

Filed under: Investigation, OOS, Out of Specification, Phase-I, Phase-II, USFDA

How to Investigate Out Of Specification(OOS) Test Results….???( USFDA Phase -I)

admin 28 Comments

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -I) Out Of Specification(OOS) :- The all test results…

Share this:

Click to share on Twitter (Opens in new window)
Click to share on Facebook (Opens in new window)
Click to share on Google+ (Opens in new window)
Click to print (Opens in new window)
Click to share on LinkedIn (Opens in new window)
Click to share on Reddit (Opens in new window)
Click to share on Tumblr (Opens in new window)
Click to share on Pinterest (Opens in new window)
Click to share on Pocket (Opens in new window)
Click to share on Telegram (Opens in new window)
Click to share on WhatsApp (Opens in new window)
Click to share on Skype (Opens in new window)

Continue Reading →

Filed under: Microbiology, Out of Specification, Out of Trend, Phase-I, Quality Control, USFDA

What is Data Integrity In Pharmaceutical Industry…???

September 29, 2018 admin 1 Comment

What is Data Integrity In Pharmaceutical Industry…??? MHRA says,”The way regulatory data is generated has continued to evolve in line…

Share this:

Click to share on Twitter (Opens in new window)
Click to share on Facebook (Opens in new window)
Click to share on Google+ (Opens in new window)
Click to print (Opens in new window)
Click to share on LinkedIn (Opens in new window)
Click to share on Reddit (Opens in new window)
Click to share on Tumblr (Opens in new window)
Click to share on Pinterest (Opens in new window)
Click to share on Pocket (Opens in new window)
Click to share on Telegram (Opens in new window)
Click to share on WhatsApp (Opens in new window)
Click to share on Skype (Opens in new window)

Continue Reading →

Filed under: Audit Trail, Data Integrity, EU Audit Requirements, MHRA, Quality Control, USFDA

Pages

Analytical Method Validation
Blog
cGMP
Contact Us
Drug Regulatory Affairs
EDQM
Gallery
Home
ICH
Maintenance
Microbiology
Privacy Policy
Process Validation
Production
Quality Assurance
Quality Control
SOP
SOP on Change control
SOP on Handling of Incidents and Deviations
SOP on Training of employees
WHO

Blog Stats

7,382 hits

Subscribe to Blog via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

Join 38 other subscribers

Email Address

Contact Us

Email
admin@pharmaguideline.net

LinkedIn
Google+
Twitter
Facebook

Home
Quality Assurance
SOP
Quality Control
Production
Microbiology
Maintenance
EDQM
Analytical Method Validation
Process Validation
Drug Regulatory Affairs
ICH
cGMP
WHO
Blog
Contact Us
Gallery
Privacy Policy

Copyright © 2018 Pharmaguideline