Log in

Contract Manufacturing Arrangements for Drugs: FDA Draft Guidance Quality Agreements

This guidance Describes our current thinking there Defining, Establishing, and Documenting the Responsibilities of Each party (or all parts) Involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP).


USP Pharmacopeial: 41 (6) In-Process Revision (November-December 2015)

"This section contains Proposals for adoption as official USP or NF standards (Either Proposed Proposed new standards or revisions of current USP or NF standards). These May be'any of the Following: (1) Proposed revisions Placed Directly under In-Process Revision, gold (2) modifications of Previously Proposed revisions under In-Process Revision. Readers shoulds review material in this section and Provide comments to the Scientific Liaison using the contact details Appearing at the end of Each proposal. Information on how to comment can be found under the "Participation" section of www.usp.org. It is significant to send comments aussitôt, using the comment deadline listed after-Each title "


EudraVigilance stakeholder management plan changes

THis paper details the exchange Taking Place in the EudraVigilance system and to the process of reporting Individual Case Safety Reports (ICSRs) and Suspected Unexpected Serious Adverse Reactions (SUSARs). These exchanges are Being brought` about by the exchange to post-permission and clinical trials legislation.

The Intended audience of this paper are the National Competent Authorities (NCAs) Marketing Authorisation Holders (MAHs), sponsors of clinical trials and the EMA. This paper details the IT & business exchange Being made at Both European and stakeholder level.


Good distribution practices for active substances for medicines for human use No. 2015 / 10 Bis

These guidelines are based on Article 47 fourth paragraph of Directive 2001 / 83 / EC of the European Parliament and of Conseil1. They follow the principles on which the guidelines are also based on the volume of 4 EudraLex, Part II, Chapter 17, regarding the distribution of active substances and the guidelines of November 5 2013 on good distribution practices wholesale medicines for human use.


Guidance on Good Data and Record Management Practices (September 2015) Draft for comment

Medicines regulatory systems worldwide-have always depended upon the knowledge of organisms That develop, manufacture and package, test, distribute and monitor pharmaceutical products. Implicit in the assessment and review process is a trust entre les regulator and the regulated que le Information submitted in folders and used in day-to-day decision-making is comprehensive, complete and reliable.

Data on qui thesis decisions are based shoulds The Therefore be full as well as Being accurate, legible, contemporaneous, original and Attributable; Commonly Referred to as "ALCOA".


a3p-100pxhaut logo


Commit to share
Transmit and progress together
Promoting innovation

The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

More info on video (Versiongb - drapeauitalie )

  group    administrators A3P
& Project Managers

letter   newsletter A3P
BROWSER A3P is a tool comprising the majority of links to texts, guides, regulatory documents and websites for the pharmaceutical, biotechnology and biomedical.
  • GMP & Guides

  • Country Sites

  • Regulatory Sites

  • Pharma areas

  • other Sites

   version 1.00                                                                                                               youtube channel   linkedin