INDUCTION

 PREVENTION OF
CROSS CONTAMINATION8
CQA-130

02/09/08 CIPLA 1
 PREVENTION OF CROSS
CONTAMINATION
 Cross Contamination related to premises.
2. Working premises are situated in the areas
with measures to protect the
manufacturing process and packing,
present with minimal risk of causing
contamination of material or product
3. Premises is maintained and daily cleaned
and disinfected as per SOP.
4. Regular sanitation and upkeep of premises
is done as per SOP.
02/09/08 CIPLA 2
 PREVENTION OF CROSS
CONTAMINATION
1. Pressure differential in the working areas is
maintained as per SOP.
2. All buildings are protected against entry of
insects and other pests.
3. Entry of unauthorised persons are strictly
prohibited in production, QC and Stores
area.
4. Dedicated self contained facilities are
provided for hormones and cytotoxics.
02/09/08 CIPLA 3
 PREVENTION OF CROSS
CONTAMINATION
1. Manufacturing of non-sterile/ sterile products is
carried out in clean/aseptic areas and entry of
equipment-material are separate and through
airlocks.
2. Weighing and sampling of starting materials
actives, exceipients are done in separate cubicles
/ areas under reverse laminar flow.

02/09/08 CIPLA 4
 PREVENTION OF CROSS
CONTAMINATION

2. Wherever possible, closed system is adapted during

manufacturing.
3. Packing areas are designed and laid out to avoid mix-
ups or cross-contamination.
4. Appropriately designed airlocks, pressure
differentials, air supply and extraction system are
provided.
5. Production areas where susceptible products are
processed undergo periodic environmental
monitoring.

02/09/08 CIPLA 5
 PREVENTION OF CROSS
CONTAMINATION
 Cross Contamination related to
equipment.
2. Equipments are designed as product contact
surface is inert and not additive or
absorptive.
3. Dedicated equipment is used for product
which are difficult to clean (e.g dedicated
finger bags.)
4. Equipments are cleaned as per relevant SOP
and wrapped with clean poly bags when they
are not in use.
02/09/08 CIPLA 6
 PREVENTION OF CROSS
CONTAMINATION
 Cross Contamination related to equipments.
(continue)
2. Vacuum cleaners are fitted with dust retaining
filters. Dedicated vacuum cleaners are provided
for the areas
3. Common equipment used for different products
should be cleaned as per validated cleaning
procedure to prevent cross contamination.

02/09/08 CIPLA 7
 PREVENTION OF CROSS
CONTAMINATION
 Cross Contamination related to equipments.
8. Dedicated trolleys are provided in each
department.

02/09/08 CIPLA 8
 PREVENTION OF CROSS
CONTAMINATION
 Cross Contamination related to processing
operations:
2. Care should be taken before starting of any operation
in the processing area for absence of any starting
material, products, product residues, previous
product. Line clearance as per respective SOP.
3. Processing of only one product should be carried out
at a time in cubicle.
4. Packing operations in packing hall should be carried
out using physical segregation between packing
lines.
02/09/08 CIPLA 9
 PREVENTION OF CROSS
CONTAMINATION
1. At all stages of processing product or
material particularly primary packing
material are protected from microbial and
other contamination.
2. Common containers, IPC’s and bins are
thoroughly cleaned before every use to avoid
any possible cross contamination.
3. Outer wrapping of packaging material is
removed before the material is issued on the
shop floor.
02/09/08 CIPLA 10
 PREVENTION OF CROSS
CONTAMINATION
1. Containers for filling should be cleaned before use to
avoid and remove any contamination due to glass
fragments and metal particles.
2. Product and product contact parts are not handled
directly with bare hands.
3. Campaign production should be followed by
appropriate cleaning in accordance with validated
cleaning procedure.
4. Materials such as lubricants, inks, cleaning fluids
should be kept in distinctly different looking containers
from containers used in production and should be
labeled as per content.
02/09/08 CIPLA 11
 PREVENTION OF CROSS
CONTAMINATION
 Cross Contamination related to Clothing:
2. Clothing and quality should be appropriate for
the process and grade of working area.
3. Clothing should be worn in such a way that it
protects the product and person from
contamination.
4. Clothing should be routinely washed at
appropriate laundry facility.

02/09/08 CIPLA 12
 PREVENTION OF CROSS
CONTAMINATION

1. During washing of linen/ clothes it is ensured

that they are not contaminated with cleaning
agent.
2. Appropriate PPE should be used when product
with special risk are handled.
3. Clothing / linen should be changed after every
product change over.

02/09/08 CIPLA 13