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What is GMP compliant Equipment

Design?
It's a frequent question what GMP-compliant equipment design is or how a system has to
be made up in order to be GMP compliant and suitable for the manufacturing of medicinal
products/APIs. The short answer is: the system has to be qualifiable.

Since this requires some clarification, here comes a more elaborate answer. To be clear
from the start, though, there is no regulatory document or general GMP certification for
equipment. This is simply impossible as pharmaceutical manufacturing processes are quite
different: dry granulation, tableting, fermentation, sterile filling and others, for example.
And if you add manufacturing processes of the classic (chemical) API production, there are
clearly more. Even the product itself can pose various requirements for the production
equipment. It makes a big difference for the design of a system whether or not the
manufactured product has to be sterile or whether the product is temperature or oxygen
sensitive. This certainly has an impact on the system design as well. But even though these
requirements are quite diverse, there are some general specifications that apply to every
GMP compliant equipment design in the GMP regulations:

 The system may not have a negative impact on product quality


 The system must be easy to clean
 The system has to comply with applicable technical rules
 The system must be suitable for its purpose

These 4 points are still so vague that further explanation is in order.

The system may not influence the product quality in a negative way. This simply means
that there may no negative interaction between product-contact surfaces and the product.
Neither may the system emit substances, nor may components of the product be absorbed.
Also, there may be no chemical reactions on the surface.

The system must be easy to clean. This generally applicable sentence can be found in
almost every GMP guidance of every country or authority. Behind it there are two
objectives: for one, all surfaces (in most cases the product-contact inner surfaces) should be
smooth. Cleaning the system by wiping or rinsing is a lot easier with smooth surfaces than
with surfaces showing score marks.  In these score marks, bacteria could survive the
cleaning or disinfection, for one; what's more, product residues could also remain there and
merge into a subsequent product. This is called cross contamination.

Even worse than rough surfaces in a system are spots which are hard to reach. Most feared
are so-called dead spots; places in a system which aren't wetted by the cleaning agent or
which the cleaning agent cannot reach at all. In system construction, these are referred to as
dead legs. Dead legs are flooded worse or not at all; they are thus harder to clean, and in the
thermal sanitisation these "branches" take longer to reach the required temperature.
This requirement also applies to equipment like packaging lines. These machines also have
to be easily cleanable, so that remaining product but also leaflets and labels can be seen and
removed during line clearance.

The system has to comply with applicable technical rules. Legally binding GMP
regulations are quite vague, especially when it comes to technical matters. Therefore, the
question is: which technical rules have to be followed? This of course depends on the
nature of the equipment. In some cases, pharmacopoeias or authority guidelines can be
helpful. Also, it's always good to know the respective ISO standards or VDI guidelines (in
Germany). Documents with further information are frequently published by associations
such as the ECA, ISPE, PDA or VDMA, for example. It's important to know here that those
rules are rarely binding. Nevertheless, they are very often used to prove that one's own
procedure is compliant with or better than the official rules.

The system must be suitable for its purpose. This is one of the most important and at the
same time hardest to generalize specifications. It simply means that the product the system
is manufactured with has to satisfy the predetermined quality requirements and therefore
has the effect the patient requires. This point pretty much covers all the other mentioned
points, as well.

The suitability of a system is proven by its qualification. Here too, the qualification depends
on the product. A system which is qualified for product A isn't necessarily suitable for
product B, as well. The qualification process begins with the user requirement specification
(URS) and continues in the phases DQ, IQ, OQ and PQ. And this is also the reason, why
GMP-compliance of a system or equipment can only be achieved together with the user. 

Tomado de www.gmp-compliance.org/gmp-news/what-is-gmp-compliant-equipment-design,
consultado el 29 de mayo de 2019.

2.  Is there a list of CDER-approved drug manufacturing equipment?

No.  The CGMP regulations neither approve nor prohibit specific equipment for use
in manufacturing of pharmaceutical products (with the exception of asbestos and
fiber-releasing filters, see 21 CFR 211.72).  We do not maintain a list of approved
equipment.  Firms are afforded the flexibility to select equipment that best satisfies
their particular needs and that is capable of meeting the relevant CGMP
requirements.  Each firm is responsible for selecting all equipment used in their
manufacturing process to produce quality products in accordance with
CGMP. They are also responsible for selecting the appropriate intended use for the
equipment's operation and are free to modify standard equipment designs to best
suit their process and that are compatible with the product under process.

The CGMPs require that equipment be of appropriate design to facilitate


operations for its intended use and for cleaning and maintenance (see 21 CFR
211.63 and 211.67) and, that any equipment surface in contact with components, in-
process materials, or drug products not be reactive, additive, or absorptive so as to
"alter the safety, identity, strength, quality, or purity of the drug product beyond
the official or other established requirements" (see 21 CFR 211.65).

References:

 21 CFR 211.63: Equipment design, size, and location


 21 CFR 211.65: Equipment construction
 21 CFR 211.67: Equipment cleaning and maintenance
 21 CFR 211.68: Automatic, mechanical, and electronic equipment
 21 CFR 211.72: Filters

Tomado de www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-
manufacturing-practices-equipment#list consultado el 29 de mayo de 2019.

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