SDVAL-PG01 o PG02 (2014 y 2013)

El diseo del equipo usado en reas de

procesamiento asptico, deber limitar el
nmero y complejidad de intervenciones
aspticas del personal.
Revisar que el principio de funcionamiento sea
acorde al uso planeado.

Cuando se espere que un equipo reciba

mantenimiento a menudo, se deber disear de
manera que sea posible ensamblar y
desensamblar piezas fcilmente.

El equipo debe minimizar la contaminacin

generada, retenida y liberada.
La definicin de los materiales de construccin
debe considerar si tendrn o no contacto con el
producto o servicio, debiendo ser sanitarios
donde se requiera.
Si se usan lubricantes no deben ser un riesgo
para el proceso o servicio.
El acabado superficial de los componentes del
equipo debe considerar si tendran o no
contacto con el producto o servicio, debiendo
ser sanitario donde se requiera

NOM-059 (2015)
El equipo de fabricacin debe ser diseado y
localizado para cumplir con el uso propuesto y
evitar riesgo de contaminacin, deben permitir
su desmontaje/montaje, limpieza,
mantenimiento y esterilizacin si aplica.
La ubicacin de los equipos de fabricacin no
debe obstaculizar los movimientos del personal,
ni las rejillas del sistema de ventilacin, estos
deben facilitar el flujo de materiales, asegurar el
orden de los procesos para controlar el riesgo
de confusin o mezcla de alguna etapa del
proceso.
El lavado, limpieza y mantenimiento de los
equipos de fabricacin no deben poner en
riesgo la calidad de los productos, ni ser fuente
de contaminacin.
Los equipos de fabricacin, sus accesorios,
utensilios y todas las tuberas deben limpiarse y
mantenerse de acuerdo con los procedimientos
escritos que detallen las actividades a realizar.
Los materiales que se consideren para el diseo
y construccin de los equipos de fabricacin y
los accesorios que estn en contacto directo
con el producto, deben ser inertes y no ser
absorbentes o adsorbentes.
Los lubricantes, refrigerantes u otras sustancias
requeridas para la operacin de los equipos de
fabricacin, no deben estar en contacto directo
con el producto o con envases primarios. En
caso de lubricantes u otras sustancias
requeridas para la operacin de los equipos de
fabricacin que podran estar en contacto con
el producto deben ser al menos grado
alimenticio, adquirirse bajo una especificacin y
establecer su manejo.

EU GMPs (2014)
Manufacturing equipment should be designed,
located and maintained to suit its intended
purpose.
Repair and maintenance operations should not
present any hazard to the quality of the
products.

Equipment should be installed in such a way as

to prevent any risk of error or of contamination.

Manufacturing equipment should be designed

so that it can be easily and thoroughly cleaned.
It should be cleaned according to detailed and
written procedures and stored only in a clean
and dry condition
Washing and cleaning equipment should be
chosen and used in order not to be a source of
contamination.

Production equipment should not present any

hazard to products. Parts of production
equipment that come into contact with the
product must not be reactive, additive or
absorptive to such an extent that it will affect
the quality of the product and thus present any
hazard.

SDVAL-PG01 o PG02 (2014 y 2013)

NOM-059 (2015)

EU GMPs (2014)

Cuando los procesos estriles sean en lnea, los

equipos (mesa banda) no deben pasar de un
rea ISO 5 o ISO 6 a otra de menor clasificacin,
a menos que el equipo cuente con su propio
sistema de aire ambiental y/o efecte la
esterilizacin de forma continua (p. ej. tnel de
despirogenizacin).
La exactitud del sistema de control debe ser
acorde a la exactitud requerida para el control
de las variables del proceso.
Los rangos de operacin del equipo deben ser
acordes a los requerimientos del proceso que se
necesita realizar en l.
La capacidad de procesamiento del equipo debe
ser acorde a la demanda requerida. La
capacidad total del equipo y de sus
componentes principales sea acorde a la
capacidad planeada.

Balances and measuring equipment of an

appropriate range and precision should be
available for production and control operations.

Una vez establecido el estado de calificacin de

un proceso, ste debe mantenerse mediante la
definicin de programas de mantenimiento
preventivo para las instalaciones, equipos y
servicios, as como para la calibracin peridica
de los instrumentos crticos de medicin.

Measuring, weighing, recording and control

equipment should be calibrated and checked at
defined intervals by appropriate methods.
Adequate records of such tests should be
maintained.
Fixed pipework should be clearly labelled to
indicate the contents and, where applicable,
the direction of flow.

Considerar si se le podr suministrar el tipo de

servicios indicados y con la calidad especificada.

El sistema de generacin y distribucin de agua

para uso farmacutico debe ser diseado,
construido y mantenido para asegurar la calidad
del agua.

Distilled, deionised and, where appropriate,

other water pipes should be sanitized according
to written procedures that detail the action
limits for microbiological contamination and the
measures to be taken.

SDVAL-PG01 o PG02 (2014 y 2013)

NOM-059 (2015)

EU GMPs (2014)
Water treatment plants and distribution
systems should be designed, constructed and
maintained so as to ensure a reliable source of
water of an appropriate quality. They should
not be operated beyond their designed
capacity. Water for injections should be
produced, stored and distributed in a manner
which prevents microbial growth, for example
by constant circulation at a temperature above
70C.

El equipo daado y en espera de

mantenimiento debe ser identificado y no
representar un riesgo para el personal y la
operacin.
Los sistemas de control deben estar en lugares
accesibles y acordes con la clase de rea en la
cual sern operados.
Los filtros empleados en la produccin o
envasado primario de productos deben ser de
materiales que no liberen fibras u otros cuerpos
extraos.
Los recipientes a presin deben ser construidos
de acuerdo a ASME u otro cdigo equivalente
internacional. Esto implica que el recipiente
debe soportar al menos 50% de exceso de la
presin interna esperada.
Ruteado estratgico de cableado y sensores
para evitar daos de los mismos en las
calibraciones.
Alarmas disponibles visual y audible que se
puedan observar en manera remota y con
registro:
- Cada de servicios (vapor, aire, suministro de
agua, etc).

Defective equipment should, if possible, be

removed from production and quality control
areas, or at least be clearly labelled as
defective.

SDVAL-PG01 o PG02 (2014 y 2013)

NOM-059 (2015)

EU GMPs (2014)

- Fallas de operacin.
Que tenga niveles de acceso para operador,
supervisor y mantenimiento (calibracin de
sensores).

El sistema de control debe tener la capacidad

de transmitir los datos crticos para su registro
impreso y/o electrnico.

A Batch Processing Record should be kept for

each batch processed. It should be based on the
relevant parts of the currently approved
Manufacturing Formula and Processing
Instructions, and should contain the following
information:
a) The name and batch number of the product;
b) Dates and times of commencement, of
significant intermediate stages and of
completion of production;
c) Identification (initials) of the operator(s) who
performed each significant step of the
process and, where appropriate, the name of
any person who checked these
operations;
d) The batch number and/or analytical control
number as well as the quantities of each
starting material actually weighed (including the
batch number and amount of any
recovered or reprocessed material added);
e) Any relevant processing operation or event
and major equipment used;
f) A record of the in-process controls and the
initials of the person(s) carrying them
out, and the results obtained;
g) The product yield obtained at different and
pertinent stages of manufacture;
h) Notes on special problems including details,
with signed authorisation for any
deviation from the Manufacturing Formula and
Processing Instructions;
i) Approval by the person responsible for the
processing operations.
Note: Where a validated process is continuously

SDVAL-PG01 o PG02 (2014 y 2013)

NOM-059 (2015)

EU GMPs (2014)
monitored and controlled, then automatically
generated reports may be limited to compliance
summaries and exception/ out-ofspecification
(OOS) data reports

El equipo debe tener sistemas de seguridad

automticos y/o mecnicos
Entrega de equipo con manuales de operacin y
mantenimiento de preferencia en espaol,
diagramas elctricos y planos de construccin.
Que se proporcione un listado de recambios
ms frecuentes, as como kit bsico de
refacciones.
Equipo se entregue con kit de refacciones con
cotizacin.
El rea donde se instale el equipo deber tener
iluminacin y espacio suficiente para darle
mantenimiento.

La iluminacin, temperatura, HR y ventilacin

deben ser adecuadas a las actividades que se
realicen en cada una de ellas y no deben afectar
directa o indirectamente al producto, equipo y
personal.
Cuando un sistema computarizado genere
registros electrnicos y/o emplee firmas
electrnicas, stos deben ser considerados en la
validacin.

Lighting, temperature, humidity and ventilation

should be appropriate and such that they do
not adversely affect, directly or indirectly, either
the medicinal products during their
manufacture and storage, or the accurate
functioning of equipment.
Computerised systems exchanging data
electronically with other systems should include
appropriate built-in checks for the correct and
secure entry and processing of data, in order to
minimize the risks
For critical data entered manually, there should
be an additional check on the accuracy of the
data. This check may be done by a second
operator or by validated electronic means. The
criticality and the potential consequences of
erroneous or incorrectly entered data to a
system should be covered by risk management.
Data should be secured by both physical and
electronic means against damage. Stored data
should be checked for accessibility, readability
and accuracy. Access to data should be ensured
throughout the retention period.

SDVAL-PG01 o PG02 (2014 y 2013)

NOM-059 (2015)
Deben contar con un sistema de proteccin,
integridad y respaldo de la informacin.

EU GMPs (2014)
Regular back-ups of all relevant data should be
done. Integrity and accuracy of backup data and
the ability to restore the data should be
checked during validation and monitored
periodically.
For records supporting batch release it should
be possible to generate printouts indicating if
any of the data has been changed since the
original entry.
Consideration should be given, based on a risk
assessment, to building into the system the
creation of a record of all GMP-relevant
changes and deletions (a system generated
"audit trail"). For change or deletion of GMPrelevant data the reason should be
documented. Audit trails need to be available
and convertible to a generally intelligible form
and regularly reviewed.
Any changes to a computerised system
including system configurations should only be
made in a controlled manner in accordance
with a defined procedure.
Computerised systems should be periodically
evaluated to confirm that they remain in a valid
state and are compliant with GMP. Such
evaluations should include, where appropriate,
the current range of functionality, deviation
records, incidents, problems, upgrade history,
performance, reliability, security and validation
status reports.
Physical and/or logical controls should be in
place to restrict access to computerized system
to authorised persons. Suitable methods of
preventing unauthorised entry to the system
may include the use of keys, pass cards,
personal codes with passwords, biometrics,
restricted access to computer equipment and
data storage areas.

SDVAL-PG01 o PG02 (2014 y 2013)

NOM-059 (2015)

EU GMPs (2014)
The extent of security controls depends on the
criticality of the computerised system.
Creation, change, and cancellation of access
authorisations should be recorded.
Management systems for data and for
documents should be designed to record the
identity of operators entering, changing,
confirming or deleting data including date and
time.
All incidents, not only system failures and data
errors, should be reported and assessed.
The root cause of a critical incident should be
identified and should form the basis of
corrective and preventive actions.

Cuando un sistema computarizado genere

registros electrnicos y/o emplee firmas
electrnicas, stos deben ser considerados en la
validacin:
Son considerados registros electrnicos los
documentos y registros que son creados,
modificados, mantenidos, archivados,
recuperados y/o transmitidos a travs de
sistemas electrnicos.
Para firmas electrnicas:
Estas deben ser nicas para cada persona e
intransferibles.
Cuando el uso de firmas electrnicas sea
adoptado, se debe establecer la fecha a partir
de la cual las firmas electrnicas son vigentes y
equivalentes a las firmas autgrafas.
Las firmas electrnicas deben contar con al
menos dos elementos distintos tales como un
cdigo de identificacin y una contrasea.

Electronic records may be signed electronically.

Electronic signatures are expected to:
a. have the same impact as hand-written
signatures within the boundaries of the
company,
b. be permanently linked to their respective
record,
c. include the time and date that they were
applied.

SDVAL-PG01 o PG02 (2014 y 2013)

NOM-059 (2015)

EU GMPs (2014)
When a computerised system is used for
recording certification and batch release, the
system should allow only Qualified Persons to
certify the release of the batches and it should
clearly identify and record the person releasing
or certifying the batches. This should be
performed using an electronic signature
For the availability of computerised systems
supporting critical processes, provisions should
be made to ensure continuity of support for
those processes in the event of a system
breakdown (e.g. a manual or alternative
system). The time required to bring the
alternative arrangements into use should be
based on risk and appropriate for a particular
system and the business process it supports.
These arrangements should be adequately
documented and tested.
Data may be archived. This data should be
checked for accessibility, readability and
integrity. If relevant changes are to be made to
the system (e.g. computer equipment or
programs), then the ability to retrieve the data
should be ensured and tested.