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DOXPUB 12-0004-SOP-1.0

Quality System/Regulatory Requirements Training

Pages: 5

Publication date: 2005-02-01

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DOXPUB 09-0005-SOP-1.0

Contact with FDA Inspectors

Pages: 6

Publication date: 2005-01-01

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DOXPUB 09-0178-SOP-1.0

Medical Device Reporting Europe

Pages: 11

Publication date: 2004-11-01

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DOXPUB 09-0179-SOP-1.0

Medical Device Reporting: USA

Pages: 5

Publication date: 2004-11-01

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DOXPUB 09-0180-SOP-1.0

EC Notification of Change Procedure

Pages: 3

Publication date: 2004-11-01

View detail

DOXPUB Category

QVD - Qualification/Validation Documents

IOP - Installation/Operational Qualification Protocol

IOR - Installation/Operational Qualification Report

IQP - Installation Qualification Protocal

IQR - Installation Qualification Report

OQP - Operational Qualification Protocol

OQR - Operational Qualification Report

PVP - Process Validation Protocol

PVP - Process Validation Protocol PVR - Process Validation Report

SOPs - Standard Operating Procedures

Bioprocessing

Clinical Research

Document Control

Environmental Health & Safety

Facilities & Equipment

General GMP Operations

Labels & Inserts

Laboratory R&D

Material Control

Medical Device

Quality Assurance

Quality Control

Regulatory Affairs

Sales & Marketing

Validation

ICS Code

(01) Generalities. Terminology. Standardization. Documentation

01.040.27 - Energy and heat transfer engineering (Vocabularies)

01.060 - Quantities and units

01.070 - Colour coding

01.075 - Character symbols

01.080 - Graphical symbols

01.100 - Technical drawings

01.020 - Terminology (principles and coordination), Including terminography

01.040 - Vocabularies

01.110 - Technical product documentation

01.120 - Standardization. General rules

01.140 - Information sciences. Publishing

(03) Services. Company organiza, management and quality. Administration. Transprort. Sociology

03.020 - Sociology. Demography

03.040 - Labour. Employment

03.060 - Finances. Banking. Monetary systems. Insurance

03.080 - Services

03.100 - Company organization and management

03.120 - Quality

03.140 - Patents. Intellectual property

03.160 - Law. Administration

03.180 - Education

03.200 - Leisure. Tourism

03.220 - Transport

03.240 - Postal services

(07) Mathematics. Natural sciences

07.020 - Mathematics

07.030 - Physics. Chemistry

07.040 - Astronomy. Geodesy. Geography

07.060 - Geology. Meteorology. Hydrology

07.080 - Biology. Botany. Zoology

07.100 - Microbiology

(11) Health care technology

11.020 - Medical sciences and health care facilities in general

11.040 - Medical equipment

11.060 - Dentistry

11.080 - Sterilization and disinfection

11.100 - Laboratory medicine

11.120 - Pharmaceutics

11.140 - Hospital equipment

11.160 - First aid

11.180 - Aids for disabled or handicapped persons

11.200 - Birth control. Mechanical contraceptives

11.220 - Veterinary medicine

(13) Environment. Health protection. Safety

13.020 - Environmental protection

13.030 - Wastes

13.040 - Air quality

13.060 - Water quality

13.080 - Soil quality. Pedology

13.100 - Occupational safety. Industrial hygiene

13.110 - Safety of machinery

13.120 - Domestic safety

13.140 - Noise with respect to human beings

13.160 - Vibration and shock with respect to human beings

13.180 - Ergonomics

13.200 - Accident and disaster control

13.220 - Protection against fire

13.230 - Explosion protection

13.240 - Protection against excessive pressure

13.260 - Protection against electric shock. Live working

13.280 - Radiation protection

13.300 - Protection against dangerous goods

13.310 - Protection against crime

13.320 - Alarm and warning systems

13.340 - Protective equipment

(17) Metrology and measurement. Physical phenomena

17.160 - Vibrations, shock and vibration measurements

17.180 - Optics and optical measurements

17.200 - Thermodynamics and temperature measurements

17.220 - Electricity. Magnetism. Electrical and magnetic measurements

17.240 - Radiation measurements

17.020 - Metrology and measurement in general

17.040 - Linear and angular measurements

17.060 - Measurement of volume, mass, density, viscosity

17.080 - Measurement of time, velocity, acceleration, angular velocity

17.100 - Measurement of force, weight and pressure

17.120 - Measurement of fluid flow

17.140 - Acoustics and acoustic measurements

(19) Testing

19.020 - Test conditions and procedures in general

19.040 - Environmental testing

19.060 - Mechanical testing

19.080 - Electrical and electronic testing

19.100 - Non-destructive testing

19.120 - Particle size analysis. Sieving

(21) Mechanical systems and components for general use

21.020 - Characteristics and design of machines, apparatus, equipment

21.040 - Screw threads

21.060 - Fasteners

21.080 - Hinges, eyelets and other articulated joints

21.100 - Bearings

21.120 - Shafts and couplings

21.140 - Seals, glands

21.160 - Springs

21.180 - Housings, enclosures, other machine parts

21.200 - Gears

21.220 - Flexible drives and transmissions

21.240 - Rotary-reciprocating mechanisms and their parts

21.260 - Lubrication systems

(23) Fluid systems and components for general use

23.020 - Fluid storage devices

23.040 - Pipeline components and pipelines

23.060 - Valves

23.080 - Pumps

23.120 - Ventilators. Fans. Air-conditioners

23.140 - Compressors and pneumatic machines

23.160 - Vacuum technology

(25) Manufacturing engineering

25.020 - Manufacturing forming processes

25.040 - Industrial automation systems

25.060 - Machine tool systems

25.080 - Machine tools

25.100 - Cutting tools

25.120 - Chipless working equipment

25.140 - Hand-held tools

25.160 - Welding, brazing and soldering

25.180 - Industrial furnaces

25.200 - Heat treatment

25.220 - Surface treatment and coating

25.240 -

(27) Energy and heat transfer engineering

27.010 - Energy and heat transfer engineering in general

27.020 - Internal combustion engines

27.040 - Gas and steam turbines. Steam engines

27.060 - Burners. Boilers

27.070 - Fuel cells

27.075 - Hydrogen technologies (Industrial application of gases, see 71.100.20)

27.080 - Heat pumps

27.100 - Power stations in general

27.120 - Nuclear energy engineering

27.140 - Hydraulic energy engineering

27.160 - Solar energy engineering

27.180 - Wind turbine energy systems

27.190 - Biological sources and alternative sources of energy

27.200 - Refrigerating technology

27.220 - Heat recovery. Thermal insulation

(29) Electrical engineering

29.160 - Rotating machinery

29.180 - Transformers. Reactors

29.200 - Rectifiers. Converters. Stabilized power supply

29.220 - Galvanic cells and batteries

29.240 - Power transmission and distribution networks

29.260 - Electrical equipment for working in special conditions

29.280 - Electric traction equipment

29.300 -

29.020 - Electrical engineering in general

29.030 - Magnetic materials

29.035 - Insulating materials

29.040 - Insulating fluids

29.045 - Semiconducting materials

29.050 - Superconductivity and conducting materials

29.060 - Electrical wires and cables

29.080 - Insulation

29.100 - Components for electrical equipment

29.120 - Electrical accessories

29.130 - Switchgear and controlgear

29.140 - Lamps and related equipment

(31) Electronics

31.020 - Electronic components in general

31.040 - Resistors

31.060 - Capacitors

31.080 - Semiconductor devices

31.100 - Electronic tubes

31.120 - Electronic display devices

31.140 - Piezoelectric devices

31.160 - Electric filters

31.180 - Printed circuits and boards

31.190 - Electronic component assemblies

31.200 - Integrated circuits. Microelectronics

31.220 - Electromechanical components for electronic and telecommunications equipment

31.240 - Mechanical structures for electronic equipment

31.260 - Optoelectronics. Laser equipment

(33) Telecommunications. Audio and video engineering

33.020 - Telecommunications in general

33.030 - Telecommunication services. Applications

33.040 - Telecommunication systems

33.050 - Telecommunication terminal equipment

33.060 - Radiocommunications

33.070 - Mobile services

33.080 - Integrated Services Digital Network (ISDN)

33.100 - Electromagnetic compatibility (EMC)

33.120 - Components and accessories for telecommunications equipment

33.140 - Special measuring equipment for use in telecommunications

33.160 - Audio, video and audiovisual engineering

33.170 - Television and radio broadcasting

33.180 - Fibre optic communications

33.200 - Telecontrol. Telemetering

(35) Information technology. Office machines

35.020 - Information technology (IT) in general

35.040 - Character sets and information coding

35.060 - Languages used in information technology

35.080 - Software

35.100 - Open systems interconnection (OSI)

35.110 - Networking

35.120 - Mang luoi dich vu to hop don le

35.140 - Computer graphics

35.160 - Microprocessor systems

35.180 - IT terminal and other peripheral equipment

35.200 - Interface and interconnection equipment

35.220 - Data storage devices

35.230 - Thiet bi nho quang hoc

35.240 - Applications of information technology

35.260 - Office machines

(37) Image technology

37.020 - Optical equipment

37.040 - Photography

37.060 - Cinematography

37.080 - Document imaging applications

37.100 - Graphic technology

(39) Precision mechanics. Jewellery

39.020 - Precision mechanics

39.040 - Horology

39.060 - Jewellery

(43) Road vehicles engineering

43.020 - Road vehicles in general

43.040 - Road vehicle systems

43.060 - Internal combustion engines for road vehicles

43.080 - Commercial vehicles

43.100 - Passenger cars. Caravans and light trailers

43.120 - Electric road vehicles

43.140 - Motorcycles and mopeds

43.150 - Cycles

43.160 - Special purpose vehicles

43.180 - Diagnostic, maintenance and test equipment

(45) Railway engineering

45.120 - Equipment for railway/cableway construction and maintenance

45.020 - Railway engineering in general

45.040 - Materials and components for railway engineering

45.060 - Railway rolling stock

45.080 - Rails and railway components

45.100 - Cableway equipment

(47) Shipbuilding and marine structures

47.020 - Shipbuilding and marine structures in general

47.040 - Seagoing vessels

47.060 - Inland navigation vessels

47.080 - Small craft

(49) Aircraft and space vehicle engineering

49.020 - Aircraft and space vehicles in general

49.025 - Materials for aerospace construction

49.030 - Fasteners for aerospace construction

49.035 - Components for aerospace construction

49.040 - Coatings and related processes used in aerospace industry

49.045 - Structure and structure elements

49.050 - Aerospace engines and propulsion systems

49.060 - Aerospace electric equipment and systems

49.080 - Aerospace fluid systems and components

49.090 - On-board equipment and instruments

49.095 - Passenger and cabin equipment

49.100 - Ground service and maintenance equipment

49.120 - Cargo equipment

49.140 - Space systems and operations

(53) Materials handling equipment

53.020 - Lifting equipment

53.040 - Continuous handling equipment

53.060 - Industrial trucks

53.080 - Storage equipment

53.100 - Earth-moving machinery

53.120 - Equipment for manual handling

(55) Packaging and distribution of goods

55.020 - Packaging and distribution of goods in general

55.040 - Packaging materials and accessories

55.060 - Spools. Bobbins

55.080 - Sacks. Bags

55.100 - Bottles. Pots. Jars

55.120 - Cans. Tins. Tubes

55.130 - Aerosol containers

55.140 - Barrels. Drums. Canisters

55.160 - Cases. Boxes. Crates

55.180 - Freight distribution of goods

55.200 - Packaging machinery

55.220 - Storing. Warehousing

55.230 - Distribution and vending machines

(59) Textile and leather technology

59.020 - Processes of the textile industry

59.040 - Textile auxiliary materials

59.060 - Textile fibres

59.080 - Products of the textile industry

59.100 - Materials for the reinforcement of composites

59.120 - Textile machinery

59.140 - Leather technology

(61) Clothing industry

61.020 - Clothes

61.040 - Headgear. Clothing accessories. Fastening of clothing

61.060 - Footwear

61.080 - Sewing machines and other equipment for the clothing industry

(65) Agriculture

65.020 - Farming and forestry

65.040 - Farm buildings, structures and installations

65.060 - Agricultural machines, implements and equipment

65.080 - Fertilizers

65.100 - Pesticides and other agrochemicals

65.120 - Animal feeding stuffs

65.140 - Beekeeping

65.145 - Hunting

65.150 - Fishing and fish breeding

65.160 - Tobacco, tobacco products and related equipment

(67) Food technology

67.160 - Beverages

67.180 - Sugar. Sugar products. Starch

67.190 - Chocolate

67.200 - Edible oils and fats. Oilseeds

67.220 - Spices and condiments. Food additives

67.230 - Prepackaged and prepared foods

67.240 - Sensory analysis

67.250 - Materials and articles in contact with foodstuffs

67.260 - Plants and equipment for the food industry

67.020 - Processes in the food industry

67.040 - Food products in general

67.050 - General methods of tests and analysis for food products

67.060 - Cereals, pulses and derived products

67.080 - Fruits. Vegetables

67.100 - Milk and milk products

67.120 - Meat, meat products and other animal produce

67.140 - Tea. Coffee. Cocoa

(71) Chemical technology

71.020 - Production in the chemical industry

71.040 - Analytical chemistry

71.060 - Inorganic chemicals

71.080 - Organic chemicals

71.100 - Products of the chemical industry

71.120 - Equipment for the chemical industry

(73) Mining and minerals

73.020 - Mining and quarrying

73.040 - Coals

73.060 - Metalliferous minerals and their concentrates

73.080 - Non-metalliferous minerals

73.100 - Mining equipment

73.120 - Equipment for processing of minerals

(75) Petroleum and related technologies

75.020 - Extraction and processing of petroleum and natural gas

75.040 - Crude petroleum

75.060 - Natural gas

75.080 - Petroleum products in general

75.100 - Lubricants, industrial oils and related products

75.120 - Hydraulic fluids

75.140 - Waxes, bituminous materials and other petroleum products

75.160 - Fuels

75.180 - Equipment for petroleum and natural gas industries

75.200 - Petroleum products and natural gas handling equipment

(77) Metallurgy

77.020 - Production of metals

77.040 - Testing of metals

77.060 - Corrosion of metals

77.080 - Ferrous metals

77.100 - Ferroalloys

77.120 - Non-ferrous metals

77.140 - Iron and steel products

77.150 - Products of non-ferrous metals

77.160 - Powder metallurgy

77.180 - Equipment for the metallurgical industry

(79) Wood technology

79.020 - Wood technology processes

79.040 - Wood, sawlogs and sawn timber

79.060 - Wood-based panels

79.080 - Semi-manufactures of timber

79.100 - Cork and cork products

79.120 - Woodworking equipment

(81) Glass and ceramics industries

81.020 - Processes in the glass and ceramics industries

81.040 - Glass

81.060 - Ceramics

81.080 - Refractories

81.100 - Equipment for the glass and ceramics industries

(83) Rubber and plastic industries

83.020 - Manufacturing processes in the rubber and plastics industries

83.040 - Raw materials for rubber and plastics

83.060 - Rubber

83.080 - Plastics

83.100 - Cellular materials

83.120 - Reinforced plastics

83.140 - Rubber and plastics products

83.160 - Tyres

83.180 - Adhesives

83.200 - Equipment for the rubber and plastics industries

(85) Paper technology

85.020 - Paper production processes

85.040 - Pulps

85.060 - Paper and board

85.080 - Paper products

85.100 - Equipment for the paper industry

(87) Paint and colour industries

87.020 - Paint coating processes

87.040 - Paints and varnishes

87.060 - Paint ingredients

87.080 - Inks. Printing inks

87.100 - Paint coating equipment

(91) Construction materials and building

91.080 - Structures of buildings

91.090 - External structures

91.100 - Construction materials

91.120 - Protection of and in buildings

91.140 - Installations in buildings

91.160 - Lighting

91.180 - Interior finishing

91.190 - Building accessories

91.200 - Construction technology

91.220 - Construction equipment

91.010 - Construction industry

91.020 - Physical planning. Town planning

91.040 - Buildings

91.060 - Elements of buildings

(93) Civil engineering

93.010 - Civil engineering in general

93.020 - Earthworks. Excavations. Foundation construction. Underground works

93.025 - External water conveyance systems (Including buried and above ground installations. Internal water supply systems, see 91.140.60)

93.030 - External water conveyance systems

93.040 - Bridge construction

93.060 - Tunnel construction

93.080 - Road engineering

93.100 - Construction of railways

93.110 - Construction of ropeway

93.120 - Construction of airports

93.140 - Construction of waterways, ports and dykes

93.160 - Hydraulic construction

(95) Military engineering

95.020 - Military engineering. Military affairs. Weapons

(97) Domestic and commercial equipment. Entertainment. Sports

97.01 - Test

97.030 - Domestic electrical appliances in general

97.040 - Kitchen equipment

97.060 - Laundry appliances

97.080 - Cleaning appliances

97.100 - Domestic, commercial and industrial heating appliances

97.120 - Automatic controls for household use

97.130 - Shop fittings

97.140 - Furniture

97.145 - Ladders

97.150 - Non-textile floor coverings

97.160 - Home textiles. Linen

97.170 - Body care equipment

97.180 - Miscellaneous domestic and commercial equipment

97.190 - Equipment for children

97.195 - Items of art and handicrafts

97.200 - Equipment for entertainment

97.220 - Sports equipment and facilities