Title: Procedure for Building Maintenance
.Document No .Version No .Supersede No
ENG/SOP/010 01 New
Preparation Date Next Review Date .Page No
15/01/2024 15/01/2027 3 Page 1 of
1.0. PURPOSE:
The purpose of this SOP is to define the procedure for building maintenance.
2.0. SCOPE:
This procedure is applicable to the maintenance of factory building in the cephalosporin dry powder
injectable manufacturing plant.
3.0. RESPONSIBILITIES:
S. No. Action Responsibility
To ensure that the work is carried out as per the defined
3.1 Maintenance Officer/
procedure.
Engineering Manager
3.2 To monitor the SOP compliance.
3.3 To audit compliance & maintaining record. QA Manager
4.0. GENERAL REQUIREMENTS:
NA
5.0. PROCEDURE:
5.1 Building area is classified in two parts:
- Core areas
- Non Critical areas
Classified areas, change rooms, microbiology lab, QC area shall be considered as core areas.
QA office, administrative office, utility area, external premise, roof shall be considered as non-
critical area.
Frequency
Core areas will be inspected every month for painting, flooring, doors, window, light fixtures,
walls and observations will be recorded in checklist.
Non- critical areas will be inspected after every six months for painting, flooring, doors, window,
light fixtures, walls and observations will be recorded in checklist.
5.2 Inspect the condition of the walls, floor, ceiling, doors, and windows of the plant as per the
building maintenance check list. If cracks or damages are noticed then arrange for repairs,
ensuring no product (at any stage) is lying in the area requiring repairs, preferably during holiday
or complete shutdown of the plant after covering of all the equipment by concerned departments.
5.3 Ensure that all the area to be painted is made available and the articles lying in the area are
properly covered.
5.4 Ensure proper removal of materials after completion of repair.
5.5 Inspect coving and epoxy paint of all the area. Repair the damaged coving and epoxy paint
whenever required.
5.6 In the manufacturing area, cracks in the wall and false ceiling will be checked visually.
5.7 All flooring work & false ceiling work will be carried out by external agencies/third party service
provider under the supervision of Engineering department personnel.
5.8 Inspect all the water drainage points on the floors of the plant building and ensure that these will
not be blocked by scrap materials or not damaged.
Written By Reviewed By Approved By
Signature & Date
Name
Designation
Title: Procedure for Building Maintenance
.Document No .Version No .Supersede No
ENG/SOP/010 01 New
Preparation Date Next Review Date .Page No
15/01/2024 15/01/2027 3 Page 2 of
5.9 Check all the entry and exit doors, door gaskets, door seals, door handles, hinges, closer, door
joints and make remarks on building maintenance check list.
5.10 Carryout repair or modifications to the building if found damaged.
5.11 Check the lights and fixtures of the building and ensure that earthings are not broken and
disconnected. Arrange for repairs as needed.
5.12 Check the utility lines for any damages and repair, if required.
5.13 During rainy season check for any leakages from the roof of the building and seepages of
accumulated water through the wall of the service floor. Mark these points and arrange for repairs
and repainting work suitably.
5.14 All check points as mentioned in the building maintenance check list will be checked by
Engineering personnel and status for the same will be filled as “OK” or “Not OK”. If it is “Not
OK” then corrective action for the same will be carried out and filled by a related Engineering
technician/representative in respective column with signature and date. After completion of work,
the check list will be verified by Head Engineering.
5.15 Clean the area to remove the dust and any other materials used for maintenance work.
5.16 Intimate user department and QA department about completion of work.
5.17 QA person will issue the controlled copy of the building maintenance check list to the
Engineering department.
6.0. DEFINITION / ABBREVIATION:
S. No. Term/word/statement Meaning/Description
- - -
7.0. REFERENCES USED:
S. No. Description
WHO good manufacturing practices for pharmaceutical products: main principles
7.1
WHO Technical Report Series No. 986, Annex 2
8.0. REFERRED DOCUMENT(S):
S. No. Document No. Description
- - -
9.0. FORMATS
S. No. Reference Number Description of Formats
9.1 ENG/SOP/010/A Building Maintenance Check List
10.0.HISTORY:
Version Number Effective Date Description of Change
01 18/01/2024 New SOP
11.0. DISTRIBUTION
Written By Reviewed By Approved By
Signature & Date
Name
Designation
Title: Procedure for Building Maintenance
.Document No .Version No .Supersede No
ENG/SOP/010 01 New
Preparation Date Next Review Date .Page No
15/01/2024 15/01/2027 3 Page 3 of
Copy No. Department Copy No. Department
Original QA Documentation Office 1. Engineering
2. Quality Control 3. Production
END OF THIS DOCUMENT
Written By Reviewed By Approved By
Signature & Date
Name
Designation
