DEFINICIONES:

BATCH (OR LOT)

EudraLex - Volume 4 Good manufacturing practice (GMP)
Guidelines.
GLOSSARY
BATCH (OR LOT)
A defined quantity of starting material, packaging material or product processed
in one process or series of processes so that it could be expected to be
homogeneous.
Note: To complete certain stages of manufacture, it may be
necessary to divide a batch into a number of sub batches, which
are later brought together to form a final homogeneous batch. In the
case of continuous manufacture, the batch must correspond to a
defined fraction of the production, characterised by its intended
homogeneity.
For control of the finished product, the following definition has been given in
Annex 1 of Directive 2001/83/EC as amended by Directive 2003/63/EC: For the
control of the finished product, a batch of a proprietary medicinal product
comprises all the units of a pharmaceutical form which are made from the same
initial mass of material and have undergone a single series of manufacturing
operations or a single sterilisation operation or, in the case of a continuous
production process, all the units manufactured in a given period of time.

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

Campaigned manufacture. The manufacture of a series of batches of the

same product in sequence in a given period of time followed by strict adherence
to accepted control measures before transfer to another product. The products
are not run at the same time but may be run on the same equipment.

Questions & answers on the code of good manufacturing

practice for medicinal products
http://www.tga.gov.au/industry/manuf-medicines-cgmp-qa.htm

Premises and equipment (Chapter 3)

34. What is the definition of 'campaign' manufacture?

Clause 5.19 defines campaign manufacture as being a separation in time
of production. That is, manufacturing a series of batches of the same
product in sequence in a given period of time and/or maximum number of
batches followed by an appropriate (validated) cleaning procedure.

PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL

INSPECTION CO-OPERATION SCHEME

PE 009-8 (Part I)
15 January 2009

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL

PRODUCTS
PART I

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;

Health Products and Food Branch Inspectorate

Good Manufacturing Practices (GMP)
Guidelines 2009 Edition, Version 2
GUI-0001
Glossary of Terms
The definitions given below apply to the terms used in these guidelines, they
also apply to the terms used in the annexes unless otherwise specified therein.
Definitions quoted from other documents are identified in brackets at the end of
the definition.

Campaign Production (production conscutive): Sequential processing of

material, either more than one product in a multi-product facility or more than
one lot of the same product in a dedicated facility, over a defined period of time.
Campaign production could occur at any point in a production process where
common rooms/suites and/or equipment are reused for multiple products/lots.