AREA QUALIFICATION PROTOCOL

AREA QUALIFICATION PROTOCOL

LOCATION                                   :

AREA                                              :

AREA CODE                                 :

REF. FACILITY

VALIDATION PROTOCOL NO.:

PREPARED BY:

NAMESIGNATUREDATE

APPROVED BY:

NAMESIGNATUREDATE

Area in Sq.Ft     :

To be used for    :

PARAMETERSPECIFICATIONVERIFICATIONREMARKS
  A]  CIVIL WORKS:-  Carryout the following checks with respect to civil works.
WALLS:
      WALL MATERIALBrick wall with cement mortar

 

      CRACKS/ CREVICESThere shall not be any cracks / crevices on the wall
      SURFACESThe wall surfaces shall be having smooth surfaces
      TYPE OF PAINT

APPLIED

Synthetic enamel /

Oil bound distemper

      COLOUR SHADEHoney Dew

 

FLOORING:
       FLOOR MATERIALKota stone / Shabad stone / Ceramic Tile (Based on the area)
       COVINGFloor to wall corners shall be having smooth coved surfaces
       CREVICESThere shall not be any crevices on the floor.
       SLOPE TOWARDS

DRAIN

The slope shall be proper to make easy flow of water towards drain.
       EASE OF CLEANINGThe floor surfaces in the area shall be easy to clean.
       STONE JOINT

MATERIAL

Epoxy / Cement

(Based on the area)

CEILING:
      CEILING MATERIALGypsum board / Cement concrete (based on the area)

 

      CRACKS/ GAPS AT

LIGHT FIXTURES

There shall not be any cracks / gaps on the ceiling, at light fixtures.
      TYPE OF PAINT

APPLIED

Synthetic enamel / Oil bound distemper
       COVINGCeiling to wall corners shall be having smooth coved surfaces
      COLOUR SHADE

 

Dull white
DOORS:
      MATERIAL OF

CONSTRUCTION

Aluminum frame with partly laminated bison and partly glazing
      MARKING OF   PUSH /

      PULL

PULL / PUSH shall be marked in all doors.
      FRAME ATTACHMENT

TO WALLS

There shall not be any projections or crevices between frame and wall surface
WINDOWS:
      MATERIAL OF

CONSTRUCTION

Aluminum frame with fully fixed tough / plane / frosted glass
      NUMBER OF

WINDOWS

Based on the area requirement
      FRAME ATTACHMENT

TO WALLS

There shall not be any projections or crevices between frame and wall surface
B] ELECTRICAL WORKS:  Carryout the following checks with respect to electrical works.
WIRING:
      CONCEALING OF

WIRING

All the electrical cables shall be concealed
      ELECRICAL SOCKETSJoints between electrical sockets and wall surface shall be coved.
      NO. OF SOCKETS /

CAPACITY

Sockets of 5-15 amp or 20-30 amp capacity based on the area requirement.

 

LIGHTING:
      NO. OF LIGHT

FIXTURES

Based on the area requirement
      LUX LEVEL150 to 300 – Storage areas

250 to 400 – Process areas

C] AIR HANDLING SYSTEM:  Carryout the following checks with respect to AHU.

      NO. OF INLET AIR

GRILLS

 

GRILL DIMENSIONS

Based on the area requirement

 

As per Annexure – I

 

      NO. OF RETURN AIR

GRILLS

 

GRILL DIMENSIONS

Based on the area requirement

 

As per Annexure – I

 

      TEMPERATURE22 ± 2º C

 

      HUMIDITYi) 50 ± 10 %

ii) 35 ± 5%

      NUMBER OF AIR

CHANGES/HOUR

i) NLT 30

ii) NLT 15

      PRESSURE

DIFFERENTIAL

All the process areas shall have negative pressure with respect to the internal corridor.
D] SERVICES/UTILITIES: Carryout the following checks with respect to services and utilities
COMPRESSED AIR:
      NO. OF POINTSBased on the area requirement

 

      SIZE OF PIPE LINE /

      MOC

½ inch, SS 316
      MOC OF CONTROL

VALVE

Teflon coated SS sheeting
      LEAKAGEThere shall not be any leakage found.

 

PARAMETERSPECIFICATIONVERIFICATIONREMARKS
POTABLE WATER:
      NO. OF POINTSBased on the requirement

 

      SIZE OF PIPE LINE /

MOC

½ inch, SS 316
      MOC OF CONTROL

VALVE

SS 316, diaphragm valve
      LEAKAGEThere shall not be any leakage found.
PURIFIED WATER:
      NO. OF POINTSBased on the requirement

 

      SIZE OF PIPE LINE /

MOC

½ inch, SS 316
      MOC OF CONTROL

VALVE

SS 316, diaphragm valve
      LEAKAGEThere shall not be any leakage found.
CHILLED WATER:
      NO. OF POINTSBased on the requirement

 

      SIZE OF PIPE LINE /

MOC

½ inch Galvazed Iron pipeline.
      MOC OF CONTROL

VALVE

Nickel coated SS sheeting
      LEAKAGEThere shall not be any leakage found in the chilled water pipe line.
DUST EXTRACTION:
      NO. OF POINTS

 

Based on the area requirement
      MODE OF

EXTRACTION

Negative suction using motor

 

PARAMETERSPECIFICATIONVERIFICATIONREMARKS

E] EQUIPMENT: Carryout the following checks with respect to equipments.

      CLEANINGThe equipment shall be cleaned as per the relevant cleaning SOP.
      MAN / MATERIAL

MOVEMENT

There shall be adequate space for man and material movement.
      INSTALLED

EQUIPMENTS

The equipment relevant to the operation shall be installed.
F] SAFETY: Carryout the following checks related to Safety.
      ACCESSIBILITY TO

EMERGENCY DOOR

Emergency door shall be easily accessible in the area. Emergency door shall be marked with separate label.
      ACCESSIBILITY TO

FIRE EXTINGUISHER

Fire extinguisher shall be easily accessible in the area with SOP.
      ACCESSIBILITY TO

FIRST AID BOX

Information regarding first aid box shall be available in the area.
G] SANITATION
      AREA CLEANINGThe area shall be thoroughly cleaned as per the relevant SOP.
      FUMIGATION

Carryout the fumigation for all critical areas.

Specifications for fumigation:

84 gm. of Potassium permanganate in 0.252 kg of formalin per 1000 cu.ft of area.

     AREA SETTLE PLATE

Carryout the area settle plate as per SOP.

Total microbial count:

NMT – 100 CFU/ plate

Total fungal count:

NMT – 10 CFU /plate

CONCLUSION:

Annexure – I

Supply and Return air grill dimensions

S.No.Type of grillDimensions
1.Bottom return air grills300 x 300 mm
2.Ceiling return air grills375 x 375 mm
3.Corridor ceiling return air grills900 x 200 mm
4.Supply air grills – SD1 (plenum)525 x 525 mm
5.Supply air grills – SD2 (plenum)700 x 700 mm
6.Supply air grills – SD300 x 300 mm
7.Supply air grills – SD 1450 x 450 mm
8.Supply air grills – MDL    (Plenum)1350 x 700 mm
9.Supply air grills – MDL 1 (Plenum)2000 x 700 mm
10.Supply and return diffusers system in ground floor450 x 450 mm

 

All Post URL of Drugs formulations

About ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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