Is there something like Authorities’ approved production equipment?

New Drug Approvals

Is there something like Authorities’ approved production equipment?
Quite often the question comes up whether this or that piece of equipment is approved by authorities, or whether there are lists with approved equipment. Get the answer here.

http://www.gmp-compliance.org/enews_4364_Is%20there%20something%20like%20Authorities%27%20approved%20production%20equipment%3F_8398,8427,8428,9087,Z-PEM_n.html

GMP News 09/07/2014

Is there something like Authorities’ approved production equipment?

Quite often the question comes up whether this or that piece of equipment is approved by authorities, or whether there are lists with approved equipment. The question can be answered with a clear ‘No’. There are approvals for pharmaceutical products only, not for production equipment. Authorities or GMP guidelines neither allow equipment, nor do they forbid their usage (with the exception of filters emitting fibers). Here, companies have the freedom of choice but also the responsibility to use the equipment appropriate for their process or product. Standard equipment can be modified to fit best on the own process. GMP guidelines require…

View original post 245 more words

Advertisement

GMP Handbooks with all major GMP and GDP Guidelines

New Drug Approvals

GMP Handbooks with all major GMP and GDP Guidelines
Everyone involved in the GMP/GDP environment needs to use the current GMP and GDP Guidelines for reference. The ECA offers a range of booklets with all major Guidelines such as the EU GMP Guide (with all current Annexes), the new EU GDP Guideline, the FDA cGMP Guide and many more. You can order the GMP booklets here.http://www.gmp-compliance.org/eca_handbuecher.html
GMP Publications
….NEW….

….NEW….
ECA Good Practice Guide on Validation
(1st Edition of October 2012)
This document is intended to provide support to both regulators and industry. On one hand, the guide contains the main elements of the new approach (“what to do”). On the other hand, it also serves as a supporting guide for the implementation (“how to do”). The guide contains 163 pages divided in 5 chapters and 4 annexes. The topics covered are among others:•Risk based qualification and validation legacy…

View original post 558 more words