SAHAJ TECHNICAL SERVICES
43, Amrapali Society- 6, Vadodara Road,
Halol -389350, Gujarat
M-9824144782,
[email protected] /
[email protected] HOW TO IMPLEMENT CONTAMINATION CONTROL
STRATEGY as per EU Annex 1
o As per revised EU ANNEX 1, A contamination control strategy requires a holistic
identification, assessment, control and monitoring process for contamination risks that
include microbiological, particulate, chemical and cross product contamination.
o The requirement for a contamination control risk assessment as detailed in these
chapters was further emphasized with the release of a new draft of Eudralex Volume 4,
Annex 1 “Manufacture of Sterile Products” which was released for review in December
2017.
o Revised EU Annex 1 emphasizes the role of Quality Risk Management in
pharmaceutical manufacturing and in particular the document clearly states that “a
contamination control strategy should be implemented across the facility in order to
assess the effectiveness of all the control and monitoring measures employed. This
assessment should lead to corrective and preventative actions being taken as
necessary. The strategy should consider all aspects of contamination control and its life
cycle with ongoing and periodic review and update of the strategy as appropriate.”
o This new revision in addition to the guidance has re-emphasized the requirement for a
formal document, which reflects the risk-based strategy for minimizing contamination
and cross contamination of medicinal products, particularly in multi-product facilities.
A contamination control strategy requires a holistic identification, assessment, control and
monitoring process for contamination risks that include microbiological, particulate,
chemical and cross product contamination.
Sahaj Technical Services has significant experience in the Design, development, training,
control and monitoring of Contamination Control for sterile and non-sterile pharmaceutical
manufacturing facilities. We will help to prepare risk assessment for the Contamination
Control and Policy for Contamination Control strategy.
We provide solution of how to implement the Contamination Control Strategy in your
organization.
SAHAJ TECHNICAL SERVICES
43, Amrapali Society- 6, Vadodara Road,
Halol -389350, Gujarat
M-9824144782,
[email protected] /
[email protected]The important source of Contamination Control is follows
Building and facilities
These can also be important contributors to
microbial contamination, which includes
Inadequate size and space which leads
to error like cross contamination, Raw
material, in-process and finished
product
Poor pest and filth control
Rough surfaces in wall, floor and
ceilings
Poorly located vents, ledges and drains
Inadequate lighting and ventilation
system
Equipment and utensils
These are common sources of microbial
contamination, which includes
Improper design and building material,
lubricants, coolants and sanitization
agents
Inadequate cleaning and sanitation
Faulty calibration and irregular
services.
Defective equipment
Personnel
Personnel working in aseptic area are
potential source of microbial contamination,
due to the following reasons
Improper gowning practices
Inadequate training
Improper hygiene practices
Direct contact between hands and
material
Unauthorized personnel entry in
aseptic area
SAHAJ TECHNICAL SERVICES
43, Amrapali Society- 6, Vadodara Road,
Halol -389350, Gujarat
M-9824144782,
[email protected] /[email protected]
Raw Material
The RM used during manufacturing are
considered a potential source of
contamination, which includes
Improper storage and handling
Degradation due to extreme
Environmental conditions
Incorrect sampling and testing
Manufacturing process
During the batch processing, below are the
potential source of microbial contamination
Inadequate facilities
Inadequate area classification
Inadequate procedure of area/ line
clearance
HVAC (Heating, Ventilation and Air
Conditioning) system
Inappropriate HVAC system is a possible
source of microbial contamination, which
includes
Material accumulates in or near HVAC
air intake
Inadequate filters
Inadequate pressure differential, which
may lead to reverse flow
Wrong ration of fresh air to re-
circulated air
