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Product :
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Product :
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Revision No. :
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Revision No. :
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1.
Introduction
One
equipment used at one stage, manufacturing of different products is very common
in pharmaceuticals manufacturing. After use, the equipment is cleaned to
prevent cross-contamination of drug products.
The
efficacy of cleaning procedure should be such that it effectively removes
traces of the previous product and detergent used.
2. Purpose
To
validate the cleaning procedure for equipments used for manufacturing is
effective to remove the ingredients of previous product and detergent used to
reduce the microbial contaminants.
3. Objective
·
To
establish a documented evidence of the cleaning effectiveness of the cleaning
procedure to a predetermined residue level.
·
To
verify that the cleaning procedure is able to clean the defined equipment
consistently and reliably.
4.
Responsibilities
I. Production Supervisor
·
To
ensure that the various pieces of equipment are cleaned according to the
relevant SOP. (SOP no :…….)
·
To
train and monitor the operator for collecting sample by final rinse/swab of the
various parts of the equipment.
II. Head of Q.C Department
·
Responsible
for validating analytical method used to analyze traces of active ingredients
of the previous product and traces of detergent used.
·
To
test sample according to validated analytical method
III. Head of Microbiology Department
·
Responsible
for validating analytical used to analyze and count the microbial contamination
IV. Head of Q.A Department
·
Responsible
for writing of the protocol and final report
·
To
supervise the operation to ensure everything is done according to the protocol
V. Production Manager
·
Responsible
for checking of the protocol and final report
VI. Engineering foreman
·
Responsible
for supporting production personnel during cleaning validation.
5. Procedure
A.
After completion of manufacturing of drug product, cleaning will be
carried out by production personnel according to the relevant SOP. (SOP No.:
…..)
B.
The production supervisor inspects the equipment visually to assure that
it is clean, and fill the inspection form.
C.
For determining the active residue, the samples are taken according to
the following steps:
·
Wipe
off the cleaned equipment with swab test kit saturated with purified water or
methanol (according to the solubility of the API of the previous product) on
the critical areas.
·
Put
the cotton swab into the vial and close the vial with plastic pilfer proof cap.
·
Then
send the collected sample to the Q.C department for analysis (method of
analysis should be validated).
D.
For determining detergent residue, the samples are taken according to the
following procedure:
·
Rinse
the clean equipment with purified water
·
Collect
approx. 500 ml from the final rinse into a clean amber glass bottle and close
the bottle with the lid.
·
Then
send the collected sample to the Q.C department for analysis (method of
analysis should be validated).
E. For determining
microbial contaminants, the sample is taken according to the following
procedure:
Open the lid of the RODAC plate.
·
Put
the nutrient agar surface on the cleaned equipment at the critical area.
·
Close
the RODAC plate with the lid immediately.
·
Then
send the RODAC plate to the Microbiological Lab for incubation.
6. Acceptance
criteria
·
The
following criteria are established:
·
Visual
examination should not reveal any evidence of contamination. The equipment will
be checked for this and will be recorded.
·
Active
ingredient of the previous product: Not more than 10 ppm.
·
Samples
from final rinse have purified water.
·
Conductivity
of the samples: Not more than 1.3µS.
·
Microbial
contaminants of the sample: Not more than 25 CFU/25 cm2
7. Corrective
action (If required)
-
If the cleaning validation results show that the equipments are below the
acceptance limits or not more than the maximum detectable limit, the cleaning
SOP is adequately validated.
-
A failure to meet this equipment would necessitate a review of the
cleaning procedure of the residual limits. Modification in the procedure to
make it more effective, or a change to more realistic limits would again
necessitate three successful cleaning of the equipment before the procedure can
be considered acceptable.
8.
Attachments
·
SOP
for cleaning of the equipments
·
Visual
inspection form
·
Surface
sampling form
·
Final
rinse sampling form
·
Monitoring
form
9. Protocol
Prepared By:
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S. No
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Name
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Department
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Signature
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Date
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1.
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Quality
Assurance
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10. Protocol
Reviewed By:
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S. No
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Name
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Department
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Signature
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Date
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1.
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Quality
Control
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2.
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Microbiology
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3.
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Production
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4.
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Engineering
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11. Protocol Approved By:
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SI. No
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Name
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Department
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Signature
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Date
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1.
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Head
of Quality Assurance
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Attachments:
Cleaning
validation visual inspection form:
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Product cleaned
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Batch No.
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Cleaned by
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Date
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Cleaning SOP No.
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Date of revision
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Protocol No.
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No.
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Equipment inspected
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Result
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Inspected by
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Date
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Clean
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Not
clean
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Remarks:
…………………………………………………………………………
Reviewed
By: ……………………… Date……………………………..
Cleaning
validation surface sampling form:
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Product cleaned
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Batch No.
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Cleaned by
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Date
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Cleaning SOP No.
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Date of revision
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Name of the equipment
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Equipment No.
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Protocol No.
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No.
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Sample type
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Sample location
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Sample code
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Area (cm2)
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Sampled By
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Date
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1.
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Microbiological
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2.
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Microbiological
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3.
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Chemical
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4.
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Chemical
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Remarks:
………………………………………………………………………………………………
Reviewed
By: ……………………… Date……………………………..
Cleaning
validation final rinse sampling form:
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Product cleaned
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Batch No.
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Cleaned by
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Date
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Cleaning SOP No.
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Date of revision
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Name of the equipment
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Equipment No.
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Protocol No.
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No.
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Sample type
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Which Part of the equipment to be use for sampling
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Sample code
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Quantity
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Sampled By
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Date
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Remarks:
……………………………………………………………………………………………………
Reviewed
By: ……………………… Date……………………………..
Cleaning validation
monitoring form:
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Product cleaned
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Batch No.
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Cleaned by
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Date
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Cleaning SOP No.
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Date of revision
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Name of the equipment
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Equipment No.
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Protocol No.
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No.
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Parameter monitored
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Sample location
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Result
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Monitored By
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Date
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1.
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Detergent
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2.
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Rinsing
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3.
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Final
rinsing
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4.
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Mop
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5.
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drying
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Remarks: ………………………………………………………………………………………………………
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Reviewed By: ……………………… Date…………………………….
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