Paragraph 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—

Test and reference items

(a)

receipt, identification, labelling, handling, sampling and storage;

Apparatus, materials and reagents

(b)

(i)

apparatus: use, maintenance, cleaning and calibration,

(ii)

computerised systems: validation, operation, maintenance, security, change control and back-up,

(iii)

materials, reagents and solutions: preparation and labelling;

Record keeping, reporting, storage, and retrieval

(c)

coding of studies, data collection, preparation of reports, indexing systems, handling of data, including the use of computerised data systems;

Test system (where appropriate)

(d)

(i)

room preparation and environmental room conditions for the test system,

(ii)

procedures for receipt, transfer, proper placement, characterisation, identification and care of test system,

(iii)

test system preparation, observation and examinations, before, during and at the conclusion of the regulatory study,

(iv)

handling of test system individuals found moribund or dead during the regulatory study,

(v)

collection, identification and handling of specimens including necropsy and histopathology,

(vi)

siting and placement of test systems in test plots;

Quality assurance procedures

(e)

operation of quality assurance personnel in planning, scheduling, performing, documenting and reporting inspections.

Notes on Schedule 1

Textual amendments

F1: Words in Sch. 1 heading substituted (27.4.2004) by The Good Laboratory Practice (Codification Amendments Etc.) Regulations 2004 (S.I. 2004/994), regs. 1, 2(d)