According with the National Standard of the Russian Federation GOST 33044-2014 «Principles of Good Laboratory Practice», the organization has separate rooms for processing test and standard objects that meet safety requirements for the storage of substances. Disposal of unused test and standard objects received to the pharmacy service, in agreement with the Sponsor, is carried out at the appropriate landfills, accompanied by environmental state unitary enterprises.
Functions of the pharmacy service:
- Acceptance and registration of research objects and accompanying documents;
- Ensuring storage, taking into account the characteristics of objects;
- Accounting and verification of good quality of objects at the stage of receipt and during storage;
- Preparation of individual doses for introduction into the test system;
- Accounting and actions with unused objects in the experiment.
Before the start of the study, the Sponsor provides the research center with: test and reference objects (including archival samples for each series of the object and samples for test preparation); analytical passport/analysis certificate/analysis protocol for each series of transferred objects; Act of Handover; safety regulations for working with objects / MSDS (if any).
Qualified and experienced specialists of the pharmacy service, guided by the requirements of the main regulatory documents, ensure the accounting and safety of drugs, convert dosage forms for convenient dosing to laboratory animals, and also control the good quality of the studied objects at all stages of work.
Work with objects begins with acceptance. During acceptance, employees check the condition of the received objects: they check the condition of the packaging, the appearance and labeling of the object and the availability of all accompanying documentation. The accompanying documentation received from the Sponsor must contain all the basic information about the object, as well as information about the storage, information about the stability of the object during storage. Employees of the pharmacy service get acquainted with the safety data sheets for the objects and inform other employees about the safety regulations during working with them.
Employees of the pharmacy service ensure the proper storage of objects for all time their presence in the organization. Objects must be stored to maintain identity, concentration, purity and stability. To ensure storage, the department has dedicated storage facilities with limited access to them. The warehouse is equipped with a safe, racks and pharmaceutical refrigerators with different storage temperatures; there also is a rack for storing archival samples. In rooms and refrigerators, constant monitoring of temperature and humidity indicators is carried out; the data are recorded twice a day. The containers in which the objects are stored are marked with the object code in the study, storage conditions and the expiration date of the object.
According to the OECD and GOST 33044-2014 «Principles of Good Laboratory Practice», in cases where the test product is provided by the Sponsor, a mechanism developed in cooperation between the Sponsor and the organization conducting preclinical trials must be presented to authenticate the objects of study. The stability of the test and control objects, both under storage conditions and under experimental conditions, should also be determined. According to the developed methods, the pharmacy service checks the obtained objects for stability during dissolution and dilution with the vehicle. For example, all suspensions intended for administration to animals are evaluated for suspension stability in terms of «pH» and «solid content».
Before starting work with the test objects, they are assigned an individual code. The coding of preparations allows for the use of a «blind» research method – a method in which employees performing the introduction of objects and obtaining data from laboratory animals do not know which of the objects the animal receives. The «blind» method reduces the number of errors caused by the conscious and unconscious interest of researchers in obtaining certain research results when analyzing data. Also, this method allows you to provide a clear and understandable labeling of the objects under study.
To ensure the administration of the test objects to laboratory animals in a convenient form, the employees of the pharmacy service prepare doses for administration. Doses are prepared extemporaneously (the storage time of prepared solutions and suspensions does not exceed 4 hours, and in special cases – no more than 10 minutes before administration to the animal). The preparation of objects for research is carried out in an equipped room, separated from the warehouse and from the rooms for keeping animals. The preparation of research objects is carried out with the help of accurate and verified weighing and measuring equipment.
RMC «HOME OF PHARMACY» has developed procedures for working with unused objects. After completion of the study, the Sponsor is notified of unspent objects. Unused items may be returned to the Sponsor or may be recycled by a specialized company.
RMC «HOME OF PHARMACY» has licenses for pharmaceutical activities (storage of medicines for veterinary use; storage of medical preparation and medicines for medical use). RMC «HOME OF PHARMACY» is registered in the system Chestny Znak. Acceptance of drugs registered in the Russian Federation can be carried out by direct or reverse acceptance, at the discretion of the Sponsor. Withdrawal from circulation of labeled medicines for research is carried out using 552 scheme (withdrawal from circulation) with code 9 (for the purposes of clinical trials) or with code 13 (write-off without transfer for destruction).
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- Kirichenko D.V. The effect of physic-chemical properties of the components of dosage forms on the selection of vehicle for the administration to laboratory animals. Laboratory Animals for Science. – 2020, №2. https://doi.org/10.29296/2618723X-2020-02-09 Abstract. This paper provides the results of the research focused on selection of the carrier of solid dosage forms, which contain components able to form polymer chains. Up to 90% of all dosage forms used as objects for research are solid dosage forms, such as tablets, capsules etc. These are the most popular and common dosage forms. On the other hand, what is comfortable if used by a man can not always be handy in preclinical tests carried out on small laboratory animals. In this paper we list the requirements for carriers, briefly review the excipients which belong to polymers, and suggest an option as how to work with such dosage forms. Based on several medications it is determined that the chemical nature of polymers affects primarily the colloidal properties of suspension which form in contact with water. It is determined that in water the majority of polymers, which are a part of solid dosage forms, form suspension solid to aggregation, which do not need additional stabilization with the help of dispersion phase. It is important to take into account not only the presence of polymers in a specific dosage form, but also the properties of these polymers. Thus, the selection of the carrier of dosage forms, which have polymers as a part either of their active ingredients or of their excipients, requires an integrated approach which should take into consideration the affection of the carrier, used for dosing laboratory animals, on physico-chemical and adsorbing properties of the active ingredients [Full text is available in Russian].