• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Stay informed!

You’d like to be regularly informed on the latest developments in Good Manufacturing Practices?

 

Subscribe to our free GMP Newsletter LOGFILE!

>>> REGISTER NOW

The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview

>>> ORDER NOW

Award for the
GMP MANUAL

GMP knowledge that convinces.

Image

On 7 June 2016 Maas & Peither GMP Publishing has received a

SIPAward in the category
"Best New Success Story" and was awarded with the 3rd place.

The GMP MANUAL impressed the jury with "Save Drugs through Better GMP Understanding".


GMP MANUAL

GMP in Practice: 24 chapters written by internationally renowned industry experts.

 

GMP Regulations: 8 chapters with the most important GMP guidelines and regulations.

 

Image

>>> READ MORE

TOP 5 GMP Downloads

1. GMP Fundamentals
A quick and comprehensive overview of the complex world of GMP.

 

2. Questionnaire for preparing GMP-inspections
More than 650 typical questions related to audits and inspections.

 

3. GDP Audit Checklist
More than 700 questions with reference to regulations.

 

4. The New USP <1231>: Water for Pharmaceutical Purposes
A detailed overview

 

5. GMP Compliance Basics of Packaging Materials and Processes
Are you on top of the best practices you need to design and create your packaging correctly — every time?

 

>>> More Downloads

News about GMP/cGMP

2010-10-27

New Australian Guideline (TGA)

The Australian Therapeutic Goods Administration (TGA) has revised it's "Guidance on Clearance of Products Manufactured Overseas". The draft has been published in September 2010. It will replace TGA's 2008 Guidance. Deadline for comments is November 15, 2010.

 

The draft widely refers to PIC/S (Pharmaceutical Inspection Cooperation Scheme) Guidelines.Thus the Australian TGA furthers progress in harmonizing their Guidelines with the PIC/S Documents. Main objectiv of this TGA Guideline is to regulate the GMP requirements concerning the import of Medicinal Products and APIs to Australia.

The main changes concern the following topics:

  • clarification of assessment requirements and processes for getting GMP clearance for overseas manufacturing sites
  • the addition of a list of sponsor responsibilities in obtaining and maintaining those clearances
  • amended evidential requirements to address difficulties experienced by sponsors in obtaining particular documents from regulators and manufacturers (including delays in the release of inspection reports)
  • a description of the criteria used for granting Clearance approval and determining its duration
  • the addition of TGA performance timeframes for the assessment of applications
  • new provisions describing the circumstances in which an application will be rejected or lapse
  • the addition of procedures for the review of GMP clearance assessments

Deadline for comments: November 15, 2010.

Outcome:

Your company is exporting Medicinal Products and APIs to Australia? Then it's up to you checking this revised Guideline intensively and exercise your right to comment the Draft!

Links:

TGA/ Australian regulatory guidelines for GMP clearance for overseas manufacturers

TGA/ Draft guideline for consultation (pdf, 197kb)

Comments
really useful information. Thanks :-)
Gajendra Dhepte 2016-09-06