REGISTRATION AND CERTIFICATION OF PRODUCTS OF MEDICAL APPOINTMENT.

THE SPECIFICATIONS, ANALITIC-STANDARD DOCUMENTATION.Set of properties which define degree

of suitability of a product (preparation) for its use to

destination characterise quality of a product (preparation). It is possible to tell also that quality of the goods

is a set of characteristics, which define level of its abilities to satisfy

requirement of people

The quantitative characteristic of one or several properties of the goods which is considered according to

consumption conditions or operation is called as a quality indicator. Each indicator has the name and value which is result of quantitative and

qualitative measurements

Set of operations from product indicators choice, definition of the

valid values and their comparison to the base indicators is an estimation

of quality of the goods or a preparation.

On a way of reception of the information on quality of production

methods of research of Qualities indicators of the goods are divided

on: organoleptic, the measuring; the sociological; the registration; the

settlement; the expert.

Goods quality assurance is the activity connected with carrying out of

examination, measurements, tests or with an estimation of one or several

characteristics of the goods and comparison of the received results

with the established norms.

Production quality assurance is carried out at different

levels SPECIALIZED CONTROL - is carried out at level of state structures. Quality of consumer goods is checked by:

Body of the State sanitary supervision; Body of veterinary supervision; Body of Public service from quarantine of

plants. Principal view of specialised control is

inspection control which is carried out by the special state body for the purpose of check of efficiency before the spent control.

The state sanitary-and-epidemiologic supervision – is activity of state bodies and establishments from control over observance legal and physical persons of the sanitary legislation of Ukraine

Carrying out of veterinary supervision is directed on release for realisation of good-quality products and raw materials of an animal origins, and also carrying out of radiological and their toxicological control

INTRAINDUSTRIAL INSPECTION - is carried out at enterprise level.

Its basic kinds: industrial (at a manufacture stage), operational.

Quality assurance functions at the enterprise are carried out by QUALITY ASSURANCE DEPARTMENT (QAD) which consists of laboratories, which carry out analytical, microbiological and pharmacological quality assurance of production.

CERTIFICATION

Certification is spent for the purpose of maintenance and improvement of quality of the goods according to recognised world norms, and also creation of conditions for export of domestic products.

Production certification is the activity directed on an establishment and acknowledgement of conformity of production to standards or other statutory acts.

Production certificate allows: To the manufacturer - to raise

competitiveness the production in the market; to extend volume sale; to reduce manufacture expenses; to increase profit.

To the consumer-to have a guarantee in stability of characteristics of production

The basic organisations in the field of standardization, metrology and

certification is State Committee on standartization, metrology and

certifications and the Ministry of building and architecture of Ukraine.

The quality certificate should comprise such information: 1. The name and the address of the manufacturer or the

supplier, the full name of the goods With instructions on a grade, a category, a kind and specific

features. 2. The characteristic of all basic indicators of quality

according to the standard documentation with instructions of the specific features.

3. Full list of components, including specific impurity. 4. Modes of manufacturing production. 5. Performance and storage terms, a way of use or finishing

to acceptance. 6. Quantity of products in party. 7. The name of transport and consumer packing. 8. Number of the corresponding documentation that

regulates properties and quality indicators. 9. The establishment name that has issued and has assured

the quality certificate.

Certificate of a pharmaceutical product This certificate conforms to the format recommended by

the World Health Organization No. of certificate Exporting (certifying country): Importing (requesting country): 1. Name and dosage form of the product: 1.1. Active ingredient(s) and amount(s) per unit dose: For complete composition including excipients, see

attached: 1.2. Is this product licensed to be placed on the market

for use in the exporting country? (yes/no) 1.3 Is this product actually on the market in the

exporting country? If the answer to 1.2. is yes, continue with section 2A and

omit section 2B. If the answer to 1.2 is no, omit section 2A and continue

with section 2B6:

2.A.1. Number of product licence and date of issue: 2.A.2. Product licence holder (name and address): 2.A.3. Status of product licence holder: (Key in appropriate category as defined

in note ) 2.A.3.1. For categories b and c the name and address of the manufacturer

producing the dosage form is: 2.A.4. Is a summary basis for approval appended? (yes/no) 2.A.5. Is the attached, officially approved product information complete and

consonent with the licence? (yes/no/not provided) 2.A.6. Applicant for certificate, if different from licence holder (name and

address): 2.B.1. Applicant for certificate (name and address): 2.B.2. Status of applicant: (Key in appropriate category as defined in footnote ) 2.B.2.1. For categories (b) and (c) the name and address of the manufacturer

producing the dosage form is: 2.B.3. Why is marketing authorization lacking? (not required/not

requested/under consideration/refused) 2.B.4. Remarks: 3. Does the certifying authority arrange for periodic inspection of the

manufacturing plant in which the dosage form is produced? (yes/no/not applicable)

If not or not applicable, proceed to question 3.1. Periodicity of routine inspections (years): 3.2. Has the manufacture of this type of dosage form been inspected? (yes/no) 3.3 Do the facilities and operations conform to GMP as recommended by the

World Health Organization? (yes/no/not applicable)

4. Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product: (yes/no)

If no, explain: Address of certifying authority: Telephone: Fax: Name of authorized person: Signature Stamp and date Explanatory notes parties.

STANDARDIZATION The great value in quality maintenance

of products of medical appointment has standardization.

Standardization (English "standard) is " an activity which is directed on achievement of optimum degree of streamlining in certain branch by an establishment of positions for the general and repeated use concerning real-life or possible tasks in sphere of manufacture and other branches of human activity.

Standardization main objective: - Realisation of a unique technical policy in

standardization sphere, metrology and certifications; - Protection of interests of the consumer and the state

concerning carelessness of production for life, health and property of citizens,

- Preservations of the environment; - Maintenance of unification, compatibility and

interchangeability of production, its reliability; - Rational use of all kinds of resources, increases of

technical and economic indicators of manufacture; - Safety of economic objects and accident precaution

and technogenic accidents; - Elimination of technical and terminological obstacles

for creation the competitor production and its exit on the world market;

- Introduction and use modern industrial and information technology.

MAIN PRINCIPLES OF STANDARDIZATION:

- The account of a level of development of a science and technics, ecological requirements, economic feasibility and efficiency of the technological processes for the manufacturer, benefit and safety for the consumer and the state as a whole;

- Harmony of standard documents from standardization with international, regional, in case of need, with the national standards of other countries;

- Maintenance of conformity of requirements of standard documents to legislation certificates;

- Participation in working out of standard documents of all interested parties (the developer, manufacturers, the consumer, body,executive power);

- Suitability of standard documents for production certification;

Distinguish the international, regional, national and state systems of standardization.

The international system - is a standardization participation in which accepts corresponding bodies of all states.

Regional system – is standardization, participation in which accepts corresponding bodies of the countries of one geographical or economic region.

National system – is standardization which is spent at level of one concrete country.

The state system – is standardization which defines a main objective and principles of management, the form and the general organizational-technical rules of performance of all kinds of works from standardization.

Standards are divided into: - The international; - The regional; - The interstate; - The national; - The state. The international standard - the standard accepted by the

international organisation from standardization. The regional standard – is the standard accepted by the

countries which have joined the Agreement on carrying out of the co-ordinated policy in branch of standardization, Metrology and certification, also it is applied by these countries.

The national standard - the standard accepted national Body Standardization of one country.

The state standard of Ukraine - is the national standard for any the world countries; it affirms the State committee of Ukraine with standardization, metrology and certification