Health Canada

Health Products and Food Branch

Health Products and Food Branch Inspectorate

Guidance Document
Cleaning Validation Guidelines
GUIDE-0028

Supersedes:
May 1, 2000
Date issued:
January 1, 2008
Date of implementation
January 1, 2008

4.0 Validation of Cleaning Processes

4.9 During a campaign (production of several batches of the same product),

cleaning between batches may be reduced. The number of lots of the same
product which could be manufactured before a complete/ full cleaning is done
should be determined.
 PDA Technical Report No. 29
Points to Consider for Cleaning Validation
DRAFT
March 30, 1998

2.6 Operational Issues

Operational issues such as the number of products manufactured, the use of

campaigns and utilization of equipment and the complexity of the equipment
impact the design of the cleaning validation program.

Campaign Production .. Batch Production

Within a multiple product facility, a production campaign may be utilized to

minimize crosscontamination issues between lots. For campaign production,
multiple lots of a single product or product family are produced in the same
equipment. In some instances, it is deemed appropriate to interrupt this
production run with what is sometimes considered a less stringent cleaning
procedure and evaluation between lots. Once the campaign has been
completed, the firm will perform an intensive cleaning of the facility and
equipment before beginning the production of a different product.

In long campaigns, the potential for contamination or product residue build-up

with time can result in concentrations higher than typical for a single lot. The
repetitive production of a single product might also result in the penetration of
materials into a location where single lot production might not present a
problem.

5. Cleaning of Equipment

5.10 Cleaning Frequency

The frequency and rigor of cleaning is usually determined by the nature of the
changeover process.

For example, the frequency will depend upon whether the manufacturing
involves many different products or several batches of the same product.

Between batches of different products

When equipment is changed over from one product to another, cleaning must
take place to prevent product cross-contamination.

Between batches of the same product (campaign)

The cleaning frequency within batches of the same product should be
determined as part of the process development. In some cases, it is possible to
show that cleaning between batches may be reduced or eliminated. Validation
should be accomplished to determine the number of lots of the same product
that may be consecutively manufactured before a more rigorous cleaning is
necessary.
 PHARMACEUTICAL INSPECTION CONVENTION
PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME

PI 006-3
25 September 2007

RECOMMENDATIONS
ON

VALIDATION MASTER PLAN

INSTALLATION AND OPERATIONAL
QUALIFICATION
NON-STERILE PROCESS VALIDATION
CLEANING VALIDATION

7. CLEANING VALIDATION

7.3 General

7.3.3 Generally in case of batch-to-batch production it is not necessary to clean

after each batch. However, cleaning intervals and methods should be
determined.
 Gerncia Geral de Inspeo e Controle de
Medicamentos e Produtos GGIMP
Gerencia General de Inspeccin y control de Medicamentos y Productos -
GGIMP

GUIAS RELACIONADOS
GARANTIA DE QUALIDADE
GUIAS RELACIONADAS A LA GARANTA DE CALIDAD

Braslia, 31 de outubro de 2006

Brasilia, 31 de octubre del 2006

www.anvisa.gov.br

2 - Procedimento de Limpeza

2. Procedimiento de limpieza

VII. Equipamentos ou materiais dedicados podem ser exigidos em alguns

casos: filtros de leitos fluidizados, produtos com alta atividade
biolgica ou toxicidade. Em casos de campanhas, onde so
realizadas limpezas parciais entre diferentes lotes de produo, a
validao de limpeza deve definir o tempo mximo de campanha. No
estudo, deve ser considerada tambm a pesquisa das impurezas. Na
etiqueta de identificao do status de limpeza deve constar nome,
concentrao, lote do ltimo produto utilizado no equipamento ou
utenslio, prazo de validade da limpeza, nome dos funcionrios que
executaram e supervisionaram a limpeza

VII Equipos de materiales dedicados pueden ser exigidos en algunos

casos: filtros de lecho fluidizado, productos con alta actividad
biolgica y toxicidad. En casos de campaas, donde se realizan
limpiezas parciales entre diferentes lotes de produccin, la validacin
de limpieza debe definir el tiempo mximo de campaa. El estudio
debe considerar la investigacin de las impurezas. La etiqueta de
identificacin del status de limpieza debe contener el nombre,
concentracin, lote del ltimo producto utilizado en el equipo y
utensilio, plazo de validez de a limpieza, nombre de los operadores
que realizaron y supervisaron la limpieza.
 CLEANING PROCESSES AND CLEANING VALIDATION

20. State the number of consecutive lots which can be manufactured without
major cleaning.

Selected FDA 483 Observations (February 2005)

Product Manufacture
[VIP ID: 138130]

Equipment cleaning, maintenance and sanitation procedures should:

b. Explain the frequency for the cleaning procedure.

Selected FDA 483 Observations (January 1999)

Product Manufacture
[VIP ID: 7110]

The number of consecutive lots which can be manufactured without

major cleaning should be stated.