CEP 2.0

Hybrid CEP

Old CEP

Format

Electronic document

Paper document

Electronic signature

Wet signature

Numbering

2-block alphanumerical                                        code

CEP 20XX-XXX-Rev 00

3-block alphanumerical code

R0-CEP 20XX-XXX-Rev 00

Information on companies

Name and address of the holder and production sites completed by SPOR OMS LOC &ORG ID

Name and address of holder and production sites

Technical information (CHEM AND HERBAL)

Inclusion of the approved specification inclusion of description of additional methods required to control the substance

Limits for additional impurities and inclusion of additional tests used in addition to the Ph. Eur. monograph tests, required to control the substance.

Expiry date

No

No reference to a validity date of 5 years (renewal is due date, on public data base)

Yes

Box of Acces- Letter of Access

Letter of Access (seperate document)

Template available on EDQM website

Box of access

On the CEP