1 documentation, 2 qualification – K-Patents PR-23 for K-Patents Appendix User Manual

Page 29

Complying with Documentation

and Validation Regulations

5.1 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). FDA’s validation requirements leave it up to the manufacturer to determine what
data is essential to prove control over their processes. Therefore, the requirements vary
from company to company, and 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.

5.2 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 a 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.

5.3 Protocol Acceptance by Customer and List of

Tests Performed

A qualification protocol which provides details about the system, the scope and constraints
of the qualification, the qualification tests, test procedures and acceptance criteria should
be available for review and approval before the qualification begins. The protocol should
also contain an exception log to record any out of the specification results, investigation and
problem resolution. After the qualification, the test results must be reviewed and approved
before the instrument can be put into routine use.