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DMF Type 2 Guide Section… A | B | C | D | E | F | G | H | I | J | K | TOC

 

F. EQUIPMENT

(a) DESIGN AND LOCATION

Describe in as much detail as possible, your production equipment. This description should include reactors, tanks, blenders, dryers, centrifuges, pumps, scales, balances, computer controllers and anything else used in the manufacture of drug products. Features and services to each reactor should also be described, i.e., agitators, condensers, nitrogen, steam, brine, etc.

Give a similar description of analytical laboratory equipment and instrumentation as well. (Scales, balances, chromatography equipment, etc.)

Be as descriptive as possible. When describing a piece of equipment such as a reactor, include all associated features. These features would include temperature measuring devices and temperature controllers, the type of agitator, pH meters, special sampling valves, any condensers, etc. Describe all services to the unit and a reference to qualification documentation.

None of the DMFs mentioned in the cover letter contain a proper description of the equipment. Each piece of equipment must be described individually.

FOR EXAMPLE:

Equipment, Reactor R-11

Last Validation Date:

(Last Validated)

Location:

(Location)

Drawing Number:

(Drawing Number)

Manufacturer:

(Manufacturer)

Model Number:

(Model Number)

Serial Number:

(Serial Number)

Features

Rated Capacity:

(4.5 - 6.5 liters)

Pressure Capacity:

(Capacity)

Construction Material:

(Glass-lined, 316SS, etc.)

Seals:

(Viton, Teflon, etc.)

Agitator Packings:

(Viton, Teflon, etc.)

Service into Reactor:

(Nitrogen, Air, etc.)

Heat Transfer Media:

(Steam, Brine, Water, etc.)

Stirrer :

(Electronic Control, x-proof, etc.)

Power:

(Compressed Air, Electric, etc.)

Working Rpm's, variable or fixed:

(Validated @ 60 to 300 RPM, etc.)

Impeller:

(Type, high sheer, dia., etc.)

Shaft Lubricants:

(Lubricant name and type)

Critical Instrumentation

Therm. and Temp. Recorder-Column:

(Brand, type, and range)

Therm. and Temp. Recorder-Vessel:

(Brand, type, and range)

Temperature/Time Controller:

(Brand, type, and range)

Pressure Gauge and Recorder:

(Brand, type, and range)

Vacuum Gauge and Recorder:

(Brand, type, and range)

pH Meter and Recorder:

(Brand, type, and range)

 

Equipment, Pump P-06

Pump Type:

(Centrifugal, etc.)

Manufacturer:

(Manufacturer)

Model Number:

(Model Number)

Serial Number:

(Serial Number)

Material:

(316SS, etc.)

Type:

(Centrifugal, positive disp., portable or non-portable, etc.)

Capacity:

(No. liters/min.)

Power:

(Compressed Air, Electric, etc.)

Seal:

(Manufacturer and Part Number)

Type of Connection:

(Type of Connection)

Critical Instrumentation

Amperage Meter and Recorder:

(Brand, type, and range)

Speed Control and Recorder

(Brand, type, and range)

Pressure Gauge and Recorder.

(Brand, type, and range)

 

(b) MAINTENANCE AND CALIBRATION

Give a general description of the routine and periodic maintenance and calibration of all equipment giving reference to the SOPs which govern this work. This description should include the following:

1. Who (title) is responsible for maintenance and calibration.

2. An explanation of the Cleaning Validation Protocol.

3. Equipment calibration and documentation procedures. Describe where log books are kept and how calibrations are scheduled.

4. Documentation procedures for repair work done internally or by outside contractors.

5. An example of a cleaning, calibration and maintenance SOP.

Give a similar description for the laboratories. Include the SOP describing the validation of reagents and standards, e.g., where they are stored, how are they labeled, how long are they kept, etc.

Include in this section an original specimen of each form associated with record keeping of maintenance, cleaning and calibration activities.

DMF Type 2 Guide Section… A | B | C | D | E | F | G | H | I | J | K | TOC
 

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