Operating instructions

Table Of Contents
Chapter 13: Appendix
96
13.2 SOPs - standard operating procedures
In the documentation of a GLP test, the SOPs are a small, but very important part.
Practical experience confirms that SOPs written in-house are followed much better than SOPs written by an an external, anonymous
source.
You will find below a brief overview of the responsibilities in relation to SOPs, as well as a checklist for creating an SOP.
Responsibilities in relation to SOPs
Head of testing laboratory Instructs SOPs to be created
Approves SOPs with date and signature
Testing supervisor Ensures that SOPs are available
Approves SOPs as deputy to laboratory head
Employees Follow the SOPs and other guidelines
GLP quality assurance Checks whether valid SOPs are available
Checks whether the SOPs are followed
Checks how and when changes are documented
Checklist for creating SOPs
Administrative matters Yes No
1. Use of SOP forms
2. Name of testing laboratory
3. Date of creation of SOP
4. Archive reference for SOPs
5. Page number (1 of n)
6. Title
7. Date of release
8. Modification number
9. Designation of departments/offices responsible for implementation
10. Date and signatures:
a) Author
b) Person checking
c) Person authorized to approve
11. Distribution list