QUALIFICATION:
Qualification is the planning, carrying out and recording of tests on equipment and systems, which form part of the validated process, to demonstrate that it will perform as intended.
All manufacturing equipment, laboratory instrument and supporting utilities shall be considered for qualification.
After successful completion of qualification exercise, the Equipment / instrument / Utilities shall be certified for its intended use.
Qualification activities include,
- Design Qualification (DQ)
- Factory Acceptance Test (FAT)
- Site Acceptance Test (SAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Re-qualification
Design qualification (DQ):
The documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose.
A User requirement specification specifies the basic requirements for the individual aspects of facility, item of equipment, utility and systems in terms of function, capacity, output, operating parameters, control system and other cGMP/ GLP requirements. A detailed user requirement specification shall not be prepared for commercially available equipment/ instrument/system.
Factory Acceptance Test (FAT):
FAT shall be carried out to ensure that all the design criteria and process requirements as laid down in the URS / Purchase order has been addressed by the vendor.
Installation qualification (IQ):
The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and manufacturer’s recommendations.
Operational qualification (OQ):
The documented verification that the facilities, system and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.
Performance qualification (PQ):
The documented verification that the facilities, system and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.
Re-qualification:
Re-qualification shall be triggered, if there is change in location from one area to another area, major modification in the equipment, which has a direct impact on the product quality. The same shall be captured through change control.
CALIBRATION:
Calibration is a set of operations performed in accordance with a definite procedure that compares the measurements performed by an instrument to those made by for more accurate instrument or standard for the purpose of Detecting, Reporting or Eliminating the errors by adjusting the parameters, if possible.
Instruments are subject to wear, corrosion, and mishandling. If they are not in good working order, they may give rise to serious analytical errors that may remain undetected unless systematic checks are made.
Whenever possible, regular servicing of instruments by specialist maintenance teams should be arranged. Instruments exposed to high levels of humidity should be resistant to corrosion and adequately protected against mould and fungal growth. Where line voltage is variable, suitable voltage stabilizers should be installed.
Some instruments may need to be protected from extremes of humidity or temperature in a specially designed area. Otherwise, analytical instruments can be either grouped together or dispersed between the various units. The choice will depend on the types of instruments, their fragility, the extent to which they are used, and the skills required to operate them. Regular calibration of all instruments used to measure the physical properties of substances is essential and specific schedules should be established for each type of instrument, having regard to the extent to which it is used. pH meters should be calibrated at least once a day. The reliability of the wavelength scale of melting-point instruments and spectrophotometers operating in the ultraviolet region should be checked once a week and a full calibration undertaken once a month. Infrared spectrophotometers require calibration every quarter, while refractometers and spectrofluorometers should be serviced half-yearly. Analytical balances should also be serviced at least half-yearly by a qualified balance specialist.
Records must be kept of each item of equipment, instrument or other device used to perform testing, verification and/or calibration. The records must include at least the following:
- the identity of the equipment, instrument or other device;
- the manufacturer’s name, the type identification, serial number or other unique identification;
- the verification and/or calibration required to comply with the specifications;
- the current location, where appropriate;
- the manufacturer’s instructions, if available, or an indication of their location;
- the dates, results and copies of reports, verifications and certificates of all calibrations, adjustments, acceptance criteria, and the due date of the next verification and/or calibration;
- the maintenance carried out to date and the maintenance plan;
- a history of any damage, malfunction, modification or repair.
PREVENTIVE MAINTENANCE:
A single or a set of service activities carried out for an Instrument / equipment to ensure that the equipment is maintained in an acceptable condition suitable for routine use.
Preventive Maintenance Schedule:
A Master preventive maintenance schedule shall be prepared once in a year by December 31st of the preceding year. This schedule shall be updated, as and when required to incorporate new equipment.
The schedules shall be categorized as Quarterly (Q), Half-yearly (H), and Yearly (Y).
- Preventive maintenance plan shall be prepared at the month end of December and June for the next six months.
- Whenever the new equipment installed, shall be incorporated in the preventive maintenance plan at end of the month as a supplement to the original preventive maintenance plan.
- Preventive maintenance schedule for every month shall be prepared based on the preventive maintenance plan.
- Preventive maintenance shall be carried out as per the scheduled date.
- Preventive maintenance schedule for next month shall be issued to concerned department in the last week of running month.
- Preventive maintenance checklists shall be prepared based on our past experience, maintenance manuals and manufacturer recommendations for every equipment.