DIA Global Regulatory Activity Digest - Drug Information Association

May-2002 (Revised Dec-2005)
Current version. This document replaces EDQM Guideline: Control Authority Batch Release
of Multivalent Pneumococcal Polysaccharide Conjugate Vaccine, May-2002 (Revised 2004)
(51315).
This document provides information on:
- the sampling and tests to be performed by the control laboratory for Multivalent
Pneumococcal Polysaccharide Conjugate Vaccine,,
- the protocol submission,
- the certification by qualified person taking overall responsibility for production and control
of the product.
This guideline came into force on 01-Jan-2005.
INTERNATIONAL - EDQM Guideline: Control Authority Batch Release
of Mumps Vaccine, Apr-1999 (Revised Dec-2005)
Current version. This document replaces EDQM Guideline: Control Authority Batch Release
of Mumps Vaccine, Apr-1999 (Revised 2004) (51319).
This revised version includes editorial changes by EDQM to update guidelines with reference
to Directive 2001/83/EC (31165).
This document provides information on:
- the sampling and tests to be performed by the control laboratory for Mumps Vaccine,
- the protocol submission,
- the certification for production and control of the product.
This revised guideline came into force on 01-Jan-2005.
INTERNATIONAL - EDQM Guideline: Control Authority Batch Release
of Pneumococcal Polysaccharide Vaccine, Apr-1999 (Revised Dec-
2005)
Current version. This document replaces EDQM Guideline: Control Authority Batch Release
of Pneumococcal Polysaccharide Vaccine, Apr-1999 (Revised Dec-2004) (51334).
This revised version includes revisions to OMCL tests approved at the annual meeting of the
OCABR network May 2003.
This document provides information on:
- the sampling and tests to be performed by the control laboratory for Pneumococcal
Polysaccharide Vaccine,
- the protocol submission,
- the certification for production and control of the product.
This revised guideline came into force on Jan-2005.