Contents of a site or plant master file

ОПИСАНИЕ МЕСТА И ПРОЦЕССА ПРОИЗВОДСТВА МЕДИЗДЕЛИЯ.

The manufacturer shall prepare a succinct document in the form of site master file containing specific information about
the production and/or control of device manufacturing carried out at the premises. Itshallcontainthefollowing
information,-

1. General Information:
(i) brief information on the site (including name and address), relation to other sites;
Address of the manufacture site is: Troitsk, Moscow, Forest str. 46, ro.No 11; ro.No86

(ii) manufacturing activities;

(iii) General Information:
The manufacture of the medical devices.

(iv) any other operations carried out on the site

(v) any other operations carried out on the site are absence.
(vi)
(vii) name and exact address of the site, including telephone, fax numbers, web site URL and e-mail address;
LTD “AGAMA+”, Troitsk, Moscow, Forest str. 46, ro.No 11; ro.No86
Теl. (499)136 22 17; www.agama-mp.ru; e-mail: mp@ agama-mp.ru

type of medical devices handled on the site and information about specifically toxic or hazardous substanceshandled,
mentioning the way they are handled and precautions taken;
The medical LED device shall be made based on the nipple case. Power unit with 3V electric battery is sealed by
compound SEAL 159-356 subject to TS 6-05-11552412-007-95. The contact of the power unit with out
environment is absent. This power unit necessary to utilize in accordance with of the local authorities
requirements.

(viii) short description of the site (size, location and immediate environment and other activities on the site);
The manufacture is situated in three rooms:
1) premise where optoelectronic block is assemblied and is sealed by compound SEAL;
Washing and drying of the medical LED device – area 8 m²
2) premise for programming, assembling of the medical LED device and controling going out parameters--
area 35m².
3) premise for DTC, packing and storage of medical LED devicies.
(ix) number of employees engaged in production, quality control, warehousing, and distribution;
6 employees engaged in production and 1 quality control employer
Production are storied indoors and then are directed to warehousing on drug-stories networks.

(viii) use of outside scientific, analytical or other technical assistance in relation to the design, manufacture and testing;

This medicine original device was developing by scientists and designers of LTD “AGAMA+”; was testing by several
medical research instituties of Moskow. The personnel of the firm is high skilled on sphere laser and optical
instruments.

(ix) short description of the quality management system of the company;

LTD “AGAMA+” are work on this direction. We have to work in ISO 9001-2015.

(x) devices details registered with foreign countries;

 Medcine device “ FIRE FLY SM” hasn’t of the foreign registration.

(xi) brief description of testing facility;

1. The laboratory balance
2.Luxmetr
3. Oscilloscope
4.Monochromator
5.Secondmetr

2. Personnel:
(i) organization charts howingthe arrangements for key personnel
(ii) qualifications, experience and responsibilities of key personnel;
Full professor; holder of an Advanced Doctorate of Medical Science -1
Ph.D of Physico-mathematical Science
Bachelor’s of Medical Science-1
Physicis-optic -1
IT engineer -

(iii) outline of arrangements for basic and in-service training and how records are maintained;

(iv) health requirements for personnel engaged in production

Personnel have the medical passes for work.

(v) personnel hygiene requirements, including clothing.

Personnel have white coats, caps, changed shoes. Medicine single masks are using on the epidemic period.

2. Premises and Facilities:

(i) layout of premises with indication of scale;
(ii) nature of construction, finishes/fixtures and fittings;
surfaces of the floor and walls is using to made the periodical damp gathering; assembly and work tables
are cover of the easily washing plastic.
(iii) brief description of ventilation systems. More details should be given for critical areas with potential risks of
airborne contamination (including schematic drawings of the systems). Classification of the rooms used for
the manufacture of sterile products should be mentioned;
Toxic, hazardous and sensitizing materials is not using on the manufacture.
(iii) brief description of water systems (schematic drawings of the systems are desirable) including sanitation;
(vi) maintenance (description of planned preventive maintenance programmes for premises and recording
system);

4. Equipment:
(i) Brief description of major production and quality control laboratories equipment (a list of the equipment is
required);
Device – light-emitted diode nipple for the irradiation of oral cavity and larynx with spectrum of blue
light in young children for prevention and treatment of mild and moderate acute types of respiratory
and ENT diseases

1.Laboratory table;
2.Programmator for optoelectronics blocks
3.The laboratory balance
4.Dryer block
5.Luxmetr
6.Monochromator
7. Oscilloscope

(ii) maintenance (descriptionofplannedpreventivemaintenanceprogrammesandrecordingsystem);

 (iii) qualification and calibration, including the recording system. Arrangements for computerized systems
validation.
5. Sanitation :
Availability of written specifications and procedures for cleaning the manufacturing areas and equipment.

6. Production:
(i) Brief description of production operations using, wherever possible, flow sheets and charts specifying
importantparameters ;
(ii) arrangements for the handling of starting materials, packaging materials, bulk and finished products,
including sampling, quarantine, release and storage;
(iii) arrangements for reprocessing or rework;
arrangements for the handling of rejected materials and products;
(iv) brief description of general policy for process validation.
LTD “AGAMA+”has the licene №ФС-99-03-003939
Registration certificate №ФСР 2011/12591
Corresponding declaration № РОСС RU. МГ11.Д14137

(v) Brief description of sterilization facility;

(vi) Device “FREE FLY SM” is unprefabricated; unrepairing; is not required to sterilize by of the delivery.
sterilization is conducted under TS 9444-001-64597171-2011

7. QualityAssurance:
Description of the quality assurance system and of the activities of the quality assurance department. Procedures
forthereleaseoffinishedproducts.

8. Storage :
Policyonthestorageofmedicaldevice.
1.1 Terms of storage of the device in package of producing company at warehouses of the supplier
(consumer) shall be in line with terms of storage 2 subject to GOST 15150.

9. Documentation :
Arrangements for the preparation, revision and distribution of necessary documentation, including storage of
masterdocuments.

10. Medical Device Complaints and Field Safety Corrective Action:

(i) Arrangements for the handling of complaints ;
(ii) Arrangements for the handling of field safety corrective action

11. Internal Audit:

Short Description of the internal audit system.

12. ContractActivities:
Description of the way in which the compliance of the contract acceptor is assessed.