Division 4 Standard operating procedures should be available for, but not be limited to, the following categories of test facility activities. The details given under each heading are to be considered as illustrative examples.
United Kingdom
- 1..
Test and reference items
Receipt, identification, labelling, handling, sampling and storage.
- 2..
Apparatus, materials and reagents
- (a)
Apparatus:
use, maintenance, cleaning and calibration
- (b)
Computerised systems:
validation, operation, maintenance, security, change control and back-up
- (c)
Materials, reagents and solutions:
preparation and labelling.
- (a)
- 3..
Record keeping, reporting, storage, and retrieval
Coding of studies, data collection, preparation of reports, indexing systems, handling of data, including the use of computerised systems.
- 4..
Test system (where appropriate)
- (a)
Room preparation and environmental room conditions for the test system.
- (b)
Procedures for receipt, transfer, proper placement, characterisation, identification and care of the test system.
- (c)
Test system preparation, observations and examinations, before, during and at the conclusion of the study.
- (d)
Handling of test system individuals found moribund or dead during the study.
- (e)
Collection, identification and handling of specimens including necropsy and histopathology.
- (f)
Siting and placement of test systems in test plots.
- (a)
- 5..
Quality assurance procedures
Operation of Quality Assurance personnel in planning, scheduling, performing, documenting and reporting inspections.