Operating instructions

Appendix
66
8.3 SOP (Standard Operating Procedure)
In the documentation of a GLP test, the SOPs represent a relatively small but none the less very important part.
Practical experience has confirmed that SOPs produced in-house can be followed much better than those produced by
an external, anonymous source.
In what follows, you will find a brief overview of the responsibilities in regard to SOPs, as well as a check list for the
production of an SOP.
Responsibilities in regard to SOPs
Head of the inspection and test
equipment
Test director
Personnel
GLP quality assurance
arranges the production of SOPs
approves SOPs with date and signature
ensures that SOPs are available
approves SOPs on behalf of the management
follow the SOPs and other directives
checks that valid SOPs are available
checks that SOPs are followed
checks whether and how modifications are documented