K-Patents PR-23 for K-Patents - Manual (Page 31)

© Copyright K-Patents 2011. All rights reserved.
31
6
6.1 Documentation
When a pharmaceutical company purchases new measuring instruments, they must take
into account the documentation requirements covered by national and international laws
and directives, for example, the US Food and Drug Authority’s Code of Federal Regulations
(CFR). These require that all processes and computerized systems directly related to
product manufacture must be subject to validation.
These requirements vary from company to company, as each pharmaceutical company is
responsible for defining and maintaining its own documentation requirements list. Some
areas to consider and their K-Patents solutions are presented in the sections below.
6.2 Qualification
The qualification action consists of proving and documenting that the equipment and
ancillary systems are properly installed, operating correctly, and producing verified results.
Qualification is part of the validation process, but the individual qualification stages alone do
not constitute process validation.
Installation Qualification, Operational Qualification and Performance Qualification protocols
are normally required to document that the correct refractometer model and parts have been
ordered, delivered and installed according to K-Patents recommendations, and also to check
that the refractometer meets its performance specification and is able to reliably measure
typical samples using the selected measurement method. Users are able to create their
own protocols using the relevant information from this manual appendix and the product
manual, and/or using their own templates. The complete qualification process must be
fully documented.
Complying with Documentation
and Validation Regulations