Standard Operating Procedures (SOPs)
Written SOPs and laboratory manuals must be present
describing the study methods to be adopted to ensure data quality and
integrity. The study director must authorize any deviations from the SOPs, which must be documented. The manuals and SOPs must be immediately available
in the area where the particular task is being performed. Data regarding all
versions of SOPs must be maintained including details of revision dates.
Minimum required SOPs in a non-clinical laboratory:
• Preparation of animal room.
• Animal care.
• Test and control articles receiving, identification,
handling, storage, mixing, and sampling methods.
• Laboratory tests.
• Test system observations.
• Handling of animals found dead in the course of the study.
• Necropsy/post-mortem examination of such animals.
• Collecting and identifying specimens.
• Histopathology study.
• Storage, handling and retrieval of data.
• Calibration and maintenance of equipment.
• Placement and identification of animals and their
transfer.
Solutions and Reagents
All solutions and reagents kept and used in the lab must be
labeled to show the identity, concentration, expiry date, and storage
requirements. Outdated substances must not be used.
Animal Care
Care, handling, feeding, and housing of animals must be done
in keeping with written procedures. When animals are newly received at the
laboratory, they must be isolated until their health status is evaluated as per
standard veterinary medical practice. Only animals without any disease or
condition that may interfere with the conduct or purpose of the study must be
used when the study begins. If a disease is contracted by the animals during
the study, such animals must be isolated if required. They may be treated for
the disease but the treatment should not interfere with the study. Details of
all such diagnoses, treatment authorization, description, and treatment dates
must be documented and archived.
Warm-blooded animals being used in the study long-term, or
those used in studies where they must be moved in and out of the cages, must be
sufficiently identified. Each animal housing unit must bear details of all the
animals housed in it. Separate housing must be provided for animals belonging
to different species if necessary. Animals of the same species must not be kept
together if they are being used in different studies as there could be a mix-up
that affects the study outcomes. If common housing is unavoidable, care must be
taken to allow separation by space and identification.
Cages, equipment, and racks must be cleaned and sanitized regularly. The water and feed supplied to the animals must be tested regularly to rule out contamination. Details of such testing must be documented as raw data. Bedding used in the cages must not interfere with the study; it should be changed often enough to ensure animals are clean and dry. Pest control materials used must not interfere with the study. The use of such materials must be documented.
Characterization of Test and Control Articles
Their purity, strength, identity, and composition must be determined and documented for every batch of control and test articles. Either the study sponsor or the testing laboratory must document their synthesis method. These articles' stability must be evaluated before the study begins or along with the study, as per written SOPs.
The containers in which test and control articles are stored
must be labeled with appropriate information such as name, code number, batch
number, storage conditions, and expiry date. Containers must not be changed
until the end of the study. When the study duration is longer than 4 weeks,
reserve samples must be drawn and retained from each batch of the control and
test articles.
Handling of Control and Test Articles
Test and control articles must be handled, stored, identified, and distributed to avoid contamination or deterioration, and their receiving and distribution (with quantities) must be documented.
Article-carrier Mixtures
When a control or test article is mixed with a carrier,
there must be tests performed to ensure mixture uniformity, concentration, and
stability of the articles in the mixture. Stability may be assessed either
before the study commences, or during the study according to written SOPs. The
expiry date of the mixture must be indicated.