Area Qualification SOP

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Area Qualification in Pharmaceutical Industries | Area Qualification Guideline |

  • Area Qualification SOP Covers below points:
    • Area qualification is divided into 5 parts
      • User Requirement Specification (URS)
      • Design Qualification (DQ)
      • Installation Qualification (IQ)
      • Operational Qualification (OQ)
      • Performance Qualification (PQ)
    • Area qualification protocol
      • Design Qualification
      • Installation Qualification
      • Operational Qualification
      • Performance Qualification
1.0 OBJECTIVE :
  • To describe the procedure for Qualification of classified areas.
2.0 SCOPE :
  • This procedure is applicable for the Area Qualification in all classified areas.
3.0 RESPONSIBILITY :
  • User Department
  • Quality Assurance Department
4.0 ACCOUNTABILITY:
  • Quality Assurance Head
5.0 PROCEDURE :

5.1 In view of continuous efforts to improve system, business, the change/ modification in area is unavoidable. It is also required as per current good manufacturing practices being attempted.

5.2 Any modification/improvement in area is carried out after taking approval from Drug Regulatory authorities. Make revised layout available.

5.3 Civil, electrical, mechanical, HVAC, flow of material and man is considered while making protocols for qualification. The specification, verification and challenge procedure for size, suitability are considered.

5.4 Nominate qualification team and draft the protocol specifically for the area under modification.

5.5 A qualification activity that centers on area is referred as area qualification. Area qualification is divided into 5 parts that is User Requirement Specification (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), & Performance Qualification (PQ).

5.6 User Requirement Specification (URS), Design Qualification (DQ), Installation Qualification (IQ) are prepared for one time in the life of area except PQ. PQ shall be repeated after scheduled interval throughout the life of the area. But if the area is modified, then based on the modification requalification (IQ, OQ & PQ) shall be performed. User has to decide the criteria for requalification based on the criticality of occasion.

5.7 Carry out follow activities as per sequence.

  • URS
  • DQ
  • IQ
  • OQ
  • PQ

5.8  User Requirement Specification:

  • This is listing of requirement considering Good Manufacturing Practices (GMP), volume, flow etc.
  • Allocate the User Requirement Specification number as follows :
  • URS/AA
  • Where,
  • URS : User Requirement Specification
  • AA   : Serial number of URS 

5.9 Design Qualification :

  • This is paper work with all specifications
  • Civil Consideration:
    • Dimensions of area, nature of constructions and finishes of wall, floors, and coving, doors (size, type), view panel etc.
    • Consider slope, types of floor, joint epoxy/ polyurethane (PU) of entire floor or joint filling.
  • Electrical Works:
    • Wiring, Lighting, Power, Switches:
    • Consider types of wire/cable, types of light (intensity, lux level, location) as per requirement.
    • Make all drawings
  • Air Handling System:
    • Consider room occupancy, classification, grade, heat load, pressure differentials, temperature, humidity.
  • Service/Utilities:
    • Compressed Air consider volume, flow rate, pressure etc, Potable / Purified / Chilled water, vacuum etc.
  • Sanitation:
    • Dust generation, method of cleaning, level of cleanliness etc.
  • Drains:
    • Avoid drain, however if required decide number, size and design.
  • General Requirement:
    • Man movement and Material Flow, Environmental condition, Pass box, Change room etc.
  • Allocate the Design Qualification number as follows :
    • DQ/AAA/YY
    • Where,
    • DQ : Design Qualification
    • AAA : Area Name
    • YY : Last Two digits of the calendar year in which the Qualification is carried out
  • Make protocol accordingly, get approved. Challenge/Verify and document in the form to report.

5.10 Installation Qualification:

  • This is verification during constructions and at final stage
  • Civil consideration:
    • Dimension of area:
      • Ensure that the air leakage through openings or penetration is kept to a minimum during construction.
      • Ensure that area is designed as per design specifications.
      • Check the dimension of the room  (length, width, and height in meters / metric system).
    • Walls:
      • Verify the wall material used.
      • Ensure that wall is free from cracks and crevices.
      • Ensure that wall have smooth surfaces and easy to clean.
      • Ensure usage of appropriate paint (quality, colour, grade, number of coatings).
    • Floors:
      • Verify the Flooring material used.
      • Ensure floor to wall corners have smooth coved surfaces.
      • Ensure that no crevices is  found on the floor.
      • Ensure slope has easy flow of water towards drain where ever it is required.
      • Ensure that floor surface in the area is easy to clean.
      • Ensure stone joining epoxy or cement is used as per requirement.
    • Ceiling:
      • Verify the Ceiling material used.
      • Ensure that no cracks / gaps on ceiling, at light fixture.
      • Check type of paint applied (Synthetic enamel/ Oil bound distemper).
      • Ensure that ceiling to wall corner have smooth coved surfaces.
    • Coving:
      • Ensure Polyurethane (PU) is used between floor and wall for coving.
      • Ensure that skirting is flushed with wall.
    • Doors:
      • Ensure design and arrangement is such that minimize migration of particulate and other contaminants into the controlled process area.
      • Material of construction, i.e, Aluminum frame with partly laminated bison and partly glazing.
      • Requirement of number of door as per area.
      • Check that proper direction stickers is provided in all door, i.e, (Push and Pull).
      • Ensure that no projection or crevices between frame and wall surface.
    • View Panel:
      • Ensure that it is properly sealed to prevent dirt accumulation.
      • Check the material of construction, as per design.
      • Check single/double  glass, colour of glass, type of glass as per requirement.
      • Check the requirement of number of view panel as per area.
  • Electrical Works:
    • Wiring:
      • Verify all the electrical cables present in the room are concealed.
      • Ensure joints between electrical sockets and wall surface is coved.
    • Lighting:
      •  Number of light fixtures based on the area requirement.
      • Check the unit of lux and compare with the standard for each room.
    • Power:
      • Location of the connections and its voltage and phase.
      • Check the location of plug point with the design specification.
  • Air Handling System:
    • Check the number of inlets air grills required as per area.
    • Hang the ducting with suitable support.
    • Verify the insulation, joints, no leakage/gap is visible.
    • Ensure that all processing area have negative pressure with respect to internal corridor.
  • Services/Utilities:
    • Compressed Air:
      • Check the number of points as per required area.
      • Ensure the material of construction of pipe and verify the size.
    • Potable Water/ Purified Water/ Chilled Water:
      • Check the number of points as per required area.
      • Ensure the material of construction of pipe and verify the size.
      • Ensure that no any leakage found.
  • Safety:
    • Ensure that emergency door are accessible in the area and marked with separate label.
    • Ensure that fire extinguisher is accessible in the area with SOP.
    • Information regarding first aid box in the area.
  • Sanitation:
    • Ensure that the area is cleaned as per SOP.
  • Drains:
    • Check number of drain points and type of drain trap as per area requirement.
    • Check the slope for water draining.
  • General Requirement :
    • Man movement and Material Flow:
      • Check the entry and exit for man and material flow.
    • Pass Box:
      • Check number of pass box and its type static or dynamic as per requirement.
  • Allocate the Installation Qualification number as follows :
    • IQ/AAA/YY
    • Where,
    • IQ : Installation Qualification
    • AAA : Area Name
    • YY : Last Two digits of the calendar year in which the Qualification carried out.
  • Make protocol accordingly, get approved. Challenge, verify and document in the form to report.

5.11 Operational Qualification :

  • Proceed the same check in Operation Qualification
    • Civil consideration
    • Electrical works
    • Air Handling system
    • Services/Utilities
    • Safety
    • Sanitation
    • Drain
    • General as above
      • Airborne Particle Count
      • Air Flow Velocity (unidirectional)
      • Air Flow Rate (non-unidirectional)
      • Room Air Change Rates
      • Air Pressure Difference Test Each day
      • Installed filter leak Test
      • Airflow Direction/ Visualization
      • Temperature & Humidity Each day
      • Recovery Test
      • Microbiological Levels Each day
  • Demonstrates and document that the area is ready as per the approved design.
  • Allocate the Operation Qualification number as follows :
    • OQ/AAA/YY
    • Where,
    • OQ : Operation Qualification
    • AAA : Area Name
    • YY : Last Two digits of the calendar year in which the Qualification is carried out
  • Make protocol accordingly, get approved. Challenge, verify and document in the form to report.

5.12 Performance Qualification:

  • Demonstrates by the execution of a series of tests that the area meets the predetermined specifications & ready for the intended use. The performance qualification will also include testing that demonstrates that all the set criteria can be met.
  • Note : The performance qualification protocol for area can only be executed after the Installation and Operational qualification protocols have been completed and report concluded.
  • Proceed the same check in Performance Qualification
    • Civil consideration
    • Electrical works
    • Air Handling system
    • Services/Utilities
    • Safety
    • Sanitation
    • Drain
    • General as above
      • During the qualification of area some test are performed in-house and some by External Agency.
        • Test to be performed In house
          • Viable count
          • Pressure differential
          • Temperature Monitoring
        • Test to be performed by External Agency.
          • HEPA filter integrity test
          • Recovery Test
          • Air flow pattern
          • ACPH
  • Allocate the Performance Qualification number as follows :
    • PQ/AAA/YY
    • Where,
    • PQ : Performance Qualification
    • AA : Area Name
    • YY : Last Two digits of the calendar year in which the Qualification carried out
  • Make protocol accordingly, get approved. Challenge, verify and document in the form to report.
  • Use the area for intended purpose once the satisfaction is concluded.
  • Carry out Periodic re-validation.
 6.0 ABBREVIATIONS:
AbbreviationExpanded form
SOPStandard Operating Procedure
QAQuality Assurance
DQDesign Qualification
IQInstallation Qualification
OQOperation Qualification
PQPerformance Qualification
GMPGood Manufacturing Practices
ACPHAir Changes Per Hour
HEPAHigh-Efficiency Particulate Air

7.0 ANNEXURES:
Annexure No.Title
01Format for DQ Protocol
02Format for DQ Report
03Format for IQ Protocol
04Format for IQ Report
05Format for OQ Protocol
06Format for OQ Report
07Format for PQ Protocol
08Format for PQ Report

8.0 SOP REFERENCES
  •  GMP Guidelines

END OF THE SOP

ANNEXURES :

Annex. No. 01 Format for DQ Protocol

Annex. No. 02 Format for DQ Report

Annex. No. 03 Format for IQ Protocol

Annex. No. 04 Format for IQ Report

Annex. No. 05 Format for OQ Protocol

Annex. No. 06 Format for OQ Report

Annex. No. 07 Format for PQ Protocol

Annex. No. 08 Format for PQ Report