COMBITIC GLOBAL CAPLET PVT LTD
TITLE: SOP FOR MAINTENANCE AND
CLEANING OF MANUFACTURING DEPARTMENT: QUALITY ASSURANCE
SURROUNDING
Issue Date Effective Date Next Review Date
SOP No. – CGC/QA/023
NOV. 2022 NOV. 2022 OCT. 2024
Revision No.: 05 Supersedes: SOP-QA/023/D-4
DOCUMENT NO.
Page 1 of 3 Prepared by Approved by Authorised by
Signature
SOP-QA/023/D-5
Date
1. Object: The objective of this SOP is to Maintenance and cleaning of pharmaceutical
surroundings as per GMP guidelines.
2. Scope: The procedure of this SOP shall be applicable for maintenance & cleaning of
COMBITIC GLOBAL CAPLET PVT LTD, Sonipat.
3. Responsibility: QA Manager, plant head.
4. Accountability: Managing Director.
5. Abbreviations:
S.O.P. : Standard Operating Procedure
QA : Quality Assurance
GMP : Good manufacturing practice
HVAC : Heating, ventilation and air conditioning
6. Procedure: A pharmaceutical manufacturing facility should be in such an environment which
protects the manufacturing process and presents minimum risk of causing any contamination to
materials or products. It should have good surrounding environment as mentioned below.
a) There should be no open sewage or drains.
b) There should be no public lavatory or any factory which produces disagreeable or obnoxious
odour or fumes.
c) There should be no factory which produces excessive soot, dust, smoke, chemical or biological
emissions.
d) The surrounding air should be neat, clean and free from radiations.
e) The surrounding area should be lush green.
COMBITIC GLOBAL CAPLET PVT LTD
TITLE: SOP FOR MAINTENANCE AND
CLEANING OF MANUFACTURING DEPARTMENT: QUALITY ASSURANCE
SURROUNDING
Issue Date Effective Date Next Review Date
SOP No. – CGC/QA/023
NOV. 2022 NOV. 2022 OCT. 2024
Revision No.: 05 Supersedes: SOP-QA/023/D-4
DOCUMENT NO.
Page 2 of 3 Prepared by Approved by Authorised by
Signature
SOP-QA/023/D-5
Date
There are some general requirements of buildings and facilities.
a) Pharmaceutical premises should provide well sanitation system.
b) Premises should be carefully maintained and repair & maintenance operations should not
present any hazard to quality of product.
c) There should be SOPs for cleaning, sanitation and disinfection of premises.
d) Electric supply, lighting, temperature, humidity & ventilation should be appropriate
e) Premises should be designed & equipped so as to allow maximum protection against entry of
insects, birds, rodents etc.
f) Ancillary areas include rest & refreshment rooms, toilets, engineering workshops etc. must be
separate from production area.
g) Production area should include separate manufacturing facilities with adequate space for
general category products, highly potent sensitive or live micro-organisms, product like
technical poisons herbicides etc. to avoid cross contamination.
h) Premises should be designed to have logical flow of materials well organized layout plant &
machinery & ease of cleaning, both equipment & facility.
i) All areas should be hard, smooth, impervious & without open joints for easy cleaning &
sanitization.
j) Drains should be adequate in size, sufficient in number & suitably located & equipped to
prevent backflow
k) Production and packaging areas should have an effective HVAC system.
l) Quality control area should be separated from production areas
COMBITIC GLOBAL CAPLET PVT LTD
TITLE: SOP FOR MAINTENANCE AND
CLEANING OF MANUFACTURING DEPARTMENT: QUALITY ASSURANCE
SURROUNDING
Issue Date Effective Date Next Review Date
SOP No. – CGC/QA/023
NOV. 2022 NOV. 2022 OCT. 2024
Revision No.: 05 Supersedes: SOP-QA/023/D-4
DOCUMENT NO.
Page 3 of 3 Prepared by Approved by Authorised by
Signature
SOP-QA/023/D-5
Date
m) Q.C lab should provide facility for wet chemical analysis instrumental analysis biological
microbiological analysis.
n) Potable water shall be supplied under continuous pressure in a plumbing system that could
prevent contamination.
o) Drains should be adequately sized & provided with an air break or other mechanical devices to
prevent backflow.
p) The number of washrooms and toilets should be based on number of people working in the
facility.
q) All building should be free of insects, rodents, birds etc. there should be SOP’s for sanitation,
use of rodenticides, insecticides, sanitizing agent etc.
