02.12.2013 |

LOGFILE No. 27/2012 - Europe: New "Outsourced Activities"

Synopsis of Chapter 7 of the EU Guide to GMP

(September 2012)

Chapter 7 is currently named "Contract Manufacture and Analysis" and it will be renamed into "Outsourced Activities". We have prepared a synopsis to get an overview of how the chapter changed in the regulatory process. We compare the versions:

  • Original Version (valid until January 31, 2013)
  • Draft Version 2010
  • Final Version 2012 (coming into operation January 31, 2013)

Find details in the comparison table and decide for yourself what changes apply to you in this area. We will also have some comments for you to review.

Link to the synopsis (PDF)

Chapter 7

Contract Manufacture and Analysis

Original Version

(Valid until January 31, 2013)

Chapter 7

Outsourced Activities

Draft 2010

Chapter 7

Outsourced Activities

Final Version 2012

(coming into operation Jan 31, 2013)

Comments

Maas & Peither

Principle

Contract manufacture and analysis must be correctly defined, agreed and controlled in order to avoid misunderstandings which could result in a product or work of unsatisfactory quality. There must be a written contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party. The contract must clearly state the way in which the Qualified Person releasing each batch of product for sale exercises his full responsibility.



 

Note: This Chapter deals with the responsibilities of manufacturers towards the Competent Authorities of the Member States with respect to the granting of marketing and manufacturing authorisations. It is not intended in any way to affect the respective liability of contract acceptors and contract givers to consumers; this is governed by other provisions of Community and national law.

Outsourced activities must be correctly defined, agreed and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality. There must be a written contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party. The Quality System of the Contract Giver must clearly state the way that the Qualified Person certifying each batch of product for release exercises his full responsibility.


 

Note: This Chapter deals with the responsibilities of manufacturers towards the Competent Authorities of the Member States with respect to the granting of marketing and manufacturing authorizations. It is not intended in any way to affect the respective liability of contract acceptors and contract givers to consumers; this is governed by other provisions of Union and national law.

Any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality. There must be a written Contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party. The Quality Management System of the Contract Giver must clearly state the way that the Qualified Person certifying each batch of product for release exercises his full responsibility.

 

Note: This Chapter deals with the responsibilities of manufacturers towards the Competent Authorities of the Member States with respect to the granting of marketing and manufacturing authorizations. It is not intended in any way to affect the respective liability of Contract Acceptors and Contract Givers to consumers; this is governed by other provisions of Community and national law.
Introduction of the new term “Quality Management System”
General
7.1 There should be a written contract covering the manufacture and/or analysis arranged under contract and any technical arrangements made in connection with it. 7.1 There should be a written contract covering the outsourced activities, the products or operations to which they are related, and any technical arrangements made in connection with it. 7.1 There should be a written Contract covering the outsourced activities, the products or operations to which they are related, and any technical arrangements made in connection with it. No change compared to the draft version.
7.2 All arrangements for contract  manufacture and analysis including any proposed changes in technical or other arrangements should be in accordance with the marketing authorisation for the product concerned. 7.2 All arrangements for the outsourced activities including any proposed changes in technical or other arrangements should be in accordance with regulations in force, and the Marketing Authorisation for the product concerned. 7.2 All arrangements for the outsourced activities including any proposed changes in technical or other arrangements should be in accordance with regulations in force, and the Marketing Authorisation for the product concerned, where applicable. An additional reference to the current regulations  is implemented.
    7.3 Where the marketing authorization holder and the manufacturer are not the same, appropriate arrangements should be in place, taking into account the principles described in this chapter. This section is valid for outsourcing strategies where the manufacturing is completely outsourced.

...

>>> Click here to see the entire synopsis (PDF)

 

 
 
 

Comments