Referencias Limpieza Entre Lote y Lote,.

FDA
Validation of Cleaning Processes
(7/93)
GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES
III. GENERAL REQUIREMENTS
FDA expects firms to have written procedures (SOP's) detailing the cleaning
processes used for various pieces of equipment. If firms have one cleaning
process for cleaning between different batches of the same product and use a
different process for cleaning between product changes, we expect the written
procedures to address these different scenario. Similarly, if firms have one
process for removing water soluble residues and another process for non-water
soluble residues, the written procedure should address both scenarios and
make it clear when a given procedure is to be followed.
La FDA espera que las empresas tengan procedimientos escritos (SOP´s)

detallando los procesos usados para varias piezas del equipo. Si las empresas
tienen un proceso para limpiar entre diferentes lotes del mismo producto
y usa un proceso diferente para limpiar entre cambios de producto,
esperamos que los procedimientos escritos hagan frente a esos
escenarios diferentes. Del mismo modo, si las empresas tienen un proceso
para remover residuos solubles en agua y otro proceso para residuos no
solubles en agua, los procedimientos escritos deben enfrentar ambos
escenarios y dejar claro cuando debe seguirse un procedimiento dado.
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074922.htm
WORLD HEALTH ORGANIZATION
SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING
PRACTICES (GMP): VALIDATION
ANNEX 3
CLEANING VALIDATION
October 2005
1. PRINCIPLE
1.5 Cleaning validation is not necessarily required for non-critical

cleaning such as between batches of the same product (or different
lots of the same intermediate in a bulk process), floors, walls,
outside of vessels, and some intermediate steps.
La validación de limpieza no es necesariamente requerida para

limpiezas no críticas tales como entre lotes del mismo producto (o
diferentes lotes del mismo intermedio en procesos a granel), pisos,
paredes, fuera de los recipientes y algunos pasos intermedios.
http://www.who.int/medicines/services/expertcommittees/pharmprep/Validation_
QAS_055_Rev2combined.pdf
CANADÁ
Health Products and Food Branch Inspectorate
Cleaning Validation Guidelines (GUIDE-0028)

January 4, 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.
4.9 Durante una campaña (producción de varios lotes del mismo producto),
la limpieza entre lotes puede ser reducida. Se debe determinar el
número de lotes del mismo producto los cuales pueden ser
manufacturados antes de que se realice una limpieza completa.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/validation/gui-
0028_cleaning-nettoyage_ltr-doc-eng.php
PHARMACEUTICAL INSPECTION CONVENTION
PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME
RECOMMENDATIONS ON
VALIDATION MASTER PLAN
INSTALLATION AND OPERATIONAL QUALIFICATION
NON-STERILE PROCESS VALIDATION
CLEANING VALIDATION
PI 006-3
25 September 2007
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.
Generalmente, en caso de producción lote a lote no es necesario
limpiar después de cada lote. Sin embargo, se deben determinar los
intervalos de limpieza y los métodos.
http://www.picscheme.org/publication.php?id=8
SINGAPUR
HEALTH SCIENCES AUTHORITY
REGULATORY GUIDANCE
CLEANING VALIDATION
DECEMBER 2008
3. GENERAL
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.
Generalmente, en caso de producción lote a lote no es necesario limpiar
después de cada lote. Sin embargo, se deben determinar los intervalos
de limpieza y los métodos.
http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_r
egulation/gmp/files_1.Par.16739.File.dat/GUIDE-MQA-008-006-web.pdf

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FDA

Validation of Cleaning Processes

La FDA espera que las empresas tengan procedimientos escritos (SOP´s)

1.5 Cleaning validation is not necessarily required for non-critical

La validación de limpieza no es necesariamente requerida para

Cleaning Validation Guidelines (GUIDE-0028)

4.0 Validation of Cleaning Processes

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

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