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ORGANIZATION OF THE MEDICINE QUALITY CONTROL SYSTEM IN PHARMACY.

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Presentation on theme: "ORGANIZATION OF THE MEDICINE QUALITY CONTROL SYSTEM IN PHARMACY."— Presentation transcript:

1 ORGANIZATION OF THE MEDICINE QUALITY CONTROL SYSTEM IN PHARMACY

2 One of elements of system of warranting of medicines quality is intrachemist's quality control. Intracliemist's quality control is an industrial activity which is directed on the prevention (warning) of the poor-quality of receipt and forged medicines from a drugstore to the patient, and also the prevention of wrong storage of medicines in chemist's establishments and pharmaceutical firms. It includes a complex of warning. measures, carrying out of obligatory and selective kinds of quality control of; medicines prepared in a drugstore.

3 If the chemist shop has the production function - preparation of medicines; under individual recipes and requirements, it should have properly organized control system of quality. First of all, it is necessary, that the full complex of measures preventing occurrence poor-quality medicines by manufacture was carried out, namely: observance of rules and norms of a sanitary-and- hygienic and epidemiological mode;

4  providing of serviceability and accuracy of the equipment;  providing of rules and conditions of storage medicines according to their physical and chemical properties;  control of recipes and hospital requirements which come in a drugstore;  observance of manufacturing techniques of medicines;  preparation of auxiliary materials, utensils according to the requirements showed to them.

5 Second, functions of the control- analytical laboratories include realization of the selective control of medicinal forms of chemist's manufacture. The drugstores has a post of the pharmacist - analitic which should held all kinds of intrachemist's quality control, and even at absence of this post, the head is obliged to provide quality control of medicines in full according to documents. Functions of the pharmacist - analytics:

6 Realization of all kinds of intrachemist's quality control; The control over observance of technology of preparing of medicines, rules of storage in a drugstore; Consultation on questions of storage, technology of preparation and quality control; Conducting registration forms under the established forms. To the intrachemist's control are exposed: all medicines prepared in a drugstore; intrachemist's preparations; solutions - concentrates; semifinished items; water cleaned and sterile.

7 There are 6 kinds of the intrachemist's control. They can be divided on: obligatory - each preparation made in conditions of a drugstore is exposed to the control, selective forms - are carried out depending on different factors (age of the* patient, the medicinal form, structure of a preparation).

8 OBLIGATORY kinds of the control The written control - consists in check of conformity of records in the passport of written control prescription in the recipe, correctness of the made calculations. Organoleptical control - is carried out as check of appearance of the medicinal 1 form, color, smell, uniformity, absence of mechanical inclusions. The control over realisation - provides conformity: packings of a medicine to the physical and chemical propertiesregistrations of a preparation dosages of medicines of the list A and age of the patient I numbers on the recipe and numbers on the label surnames of the patient on the receipt and on the medicine

9 The SELECTIVE forms of the control: The polling (oral) control is carried out after manufacturing by the pharmacist no more than 5 medicinal forms. The pharmacist who is carrying out the control, calls 1 the first component, and the assistant should call components of the medicinal form and their amounts.

10 The physical control - is carried out by check of a weight or volume of the medicinal form, quantity(amount) and weight of separate components, and also by means of quality control of packing. The subject to check: 3-5 units of packing or preparations in each series of packing or preparation sterile medicinal forms

11 The chemical control includes the definition of authenticity (the qualitative analysis) and the quantitative contents of the medicines included in the medicinal form.

12 The chemical control is obligatory for the following medicinal forms: Solutions for injections; Eye drops and the ointments containing narcotic, strong, poisonous substances; Medicinal forms for newborns; Solutions of an acid for internal application; Concentrates, the semifinished items prepared in a drugstore; Stabilizers, the buffer solutions used for manufacturing of injection solutions; Series of intrachemist's medicines.

13 The qualitative chemical control is carried out for the following forms: Water cleared from each cylinder daily. Medicines, concentrates, the semifinished items acting in assistant their rooms of storage. Concentrates, the semifinished items coming from a warehouse - in case of doubt. Estimation ofqualitv of medicines There are 2 terms of quality estimation of the made medicines: "Satisfactory" "Unsatisfactory"

14 «It is unsatisfactory on conformity »: absence of the attributed component; presence of not registered component; use of preparation - analogue without corcesponding instructions (indications) of the doctor in the recipe;

15 « It is unsatisfactory on physical parameters »: bad mixing or grinding of components; impurity of a solution with mechanical inclusions; excess of norms of a deviation of separate dozes, lump (volume).


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