• 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 Compliance Adviser

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 (now: GMP Compliance Adviser) impressed the jury with "Safe Drugs through Better GMP Understanding".


GMP Compliance Adviser

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


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


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


4. Industry Guide to handle OOX Test Results
Every single step of the OOX process.


5. The New USP <1231>: Water for Pharmaceutical Purposes
A compact overview of the contents of the new version of USP <1231>.


>>> More Downloads

News about GMP/cGMP

2018-05-14

PIC/S Meeting in April 2018

From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.

 

The results at a glance:

  • New PIC/S guidance on GMP inspection reliance based on a draft by ICMRA with the aim to maximise inspection resources for GMP compliance of overseas facilities.
  • Revision of PIC/S GMP guide (PE 009).
    Chapters 3, 5 and 8 of the PIC/S GMP guide have been revised and will enter into force on 1 July 2018.
    The revised Chapters 3, 5 & 8 of the PIC/S GMP Guide are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language. These Chapters of the PIC/S GMP Guide have now been aligned with principles of Quality Risk Management. Chapter 3 and 5 have been revised to include requirements to prevent cross-contamination.
    Expectations with regard to quality management system for the evaluation of quality defects in relation to product recalls have been expanded in Chapter 8, which has been entirely revised.
  • New PIC/S working group established with WHO to revise annex 2 on biologicals and ATMP.
    The objective is to advance a recommendation to the PIC/S Committee on a strategy to harmonise where possible with the EC guidelines while addressing the perceived concerns raised by PIC/S Participating Authorities which have led to an international divergence in this field.
  • The PIC/S Working Group on Data Integrity has revised the Draft PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments.
    The Committee agreed to a focused stakeholder consultation.
  • New PIC/S aide-memoire on cross-contamination in shared facilities. The document will enter into force on 1 July 2018.
  • The PIC/S Committee adopted the transposition for PIC/S purposes of the following European Commission (EC) guidance documents:
    - Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (PI 045-1);
    - Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (PI 046-1);
    - Guidelines on the principles of Good Distribution Practice for active substances for medicinal products for human use (PI 047-1).
    These Guidelines will enter into force on 1 July 2018.
  • Ongoing PIC/S membership applications (e.g. Armenia, Brazil, Italy, Pakistan, Russian Federation, Minpromtorg Russia and FSI, Saudi Arabia)
  • New PIC/S working groups to be established on whistle-blowers/confidential informants; quality defects procedures; as well as PIC/S assessment and re-assessment procedures.
Source:

PIC/S Press Release

 

Comments
No comment has yet been written about this news.
 
 
Literature recommendation
GMP Compliance Adviser
Single User Licence (monthly subscription)