Professional Documents
Culture Documents
Campaign:
PDA Technical Report No. 29
Points to Consider for
Cleaning Validation
DRAFT
March 30, 1998
Campaign: processing of more than one product in the same facility and/or
equipment in a sequential manner; only one product is present in any one
manufacturing area of the facility at a time.
EUROPEAN COMMISSION
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Health Systems and Products
Medicinal Products - Quality, safety and efficacy
EudraLex
The Rules Governing Medicinal Products in the European Union
Volume 4
EU guidelines for
Good Manufacturing Practice for
Medicinal Products for Human and Veterinary Use
Annex 2
Manufacture of Biological active substances and Medicinal Products for
Human
Use
Ref. Ares(2012)778531 - 28/06/2012
PE 009-8 (Part I)
15 January 2009
CHAPTER 5
PRODUCTION
5.19. Cross-contamination should be avoided by appropriate technical or
organisational measures, for example:
a) production in segregated areas (required for products such as penicillins, live
vaccines, live bacterial preparations and some other biologicals), or by
campaign (separation in time) followed by appropriate cleaning;