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PT. CAPRIFARMINDO STANDARD OPERATING PROCEDURE
LABORATORIES Revision No.: 06
Subject : Production Equipment Document No.: Next Review Date:
Cleaning Validation VAL-LV/SOP/CP/001
Location/Department : Validation
Effective Date : Prepared by, Reviewed by, Reviewed by,

Solid Production
Validation Engineer Validation Manager Manager I
Reviewed by, Reviewed by, Reviewed by,

Solid Production Liquid & Semisolid Liquid Production

Manager II Production Manager I Manager II
Reviewed by, Reviewed by, Approved by,

QC Manager QA Manager Head of Quality

TABLE OF CONTENT
1. PURPOSE.....................................................................................................................................3
2. SCOPE..........................................................................................................................................3
3. DEFINITION...............................................................................................................................3
3.1. Acceptance Criteria.............................................................................................................3
3.2. Bracketing...........................................................................................................................3
3.3. Change Management...........................................................................................................3

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3.4. Cleaning Validation.............................................................................................................4

3.5. Cross Contamination...........................................................................................................4
3.6. Final Rinse..........................................................................................................................4
3.7. LD50....................................................................................................................................4
3.8. Re-Validation......................................................................................................................4
3.9. Recovery Study...................................................................................................................4
3.10. Risk Analysis .................................................................................................................... 4
3.11. Risk Management...............................................................................................................4
3.12. Worst Case..........................................................................................................................4
4. REFERENCES.............................................................................................................................5
5. RESPONSIBILITY AND AUTHORITY.....................................................................................5
5.1. Production Department.........................................................................................................5
5.2. QC Department.....................................................................................................................5
5.3. Validation Department..........................................................................................................6
5.4. QA Department.....................................................................................................................6
6. CLEANING VALIDATION PROCEDURES..............................................................................6
7. EQUIPMENT................................................................................................................................7
8. PROCEDURES.............................................................................................................................7
8.1. Bracketing...........................................................................................................................7
8.2. Sampling Method................................................................................................................8
8.2.1 Determining Active Ingredient …............................................................................8
8.2.2 Determining Microbial Contaminant ......................................................................9
8.2.3 Determining Detergent Residue ........................................................................... 11
8.3. Acceptance Criteria/ Residue Limit Determination..........................................................11
8.3.1. Acceptance Criteria for Swab Method......................................................................12
8.3.2. Acceptance Criteria for Rinse Method......................................................................13
8.4. Sampling Plan...................................................................................................................14
8.5. Assay Method....................................................................................................................14
8.6. Action Taken When Out of Limit Result Found...............................................................15
8.7. Monitoring Validated Cleaning Process........................................................................... ...15 .

8.8. Change Management............................................................................................................15

9. EVALUATION............................................................................................................................15
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PT. CAPRIFARMINDO STANDARD OPERATING PROCEDURE
LABORATORIES Revision No.: 06
Subject : Production Equipment Document No.: Next Review Date:
Cleaning Validation VAL-LV/SOP/CP/001
Location/Department : Validation
Effective Date : Prepared by, Reviewed by, Reviewed by,

Solid Production
Validation Engineer Validation Manager Manager I
Reviewed by, Reviewed by, Reviewed by,

Solid Production Liquid & Semisolid Liquid Production

Manager II Production Manager I Manager II
Reviewed by, Reviewed by, Approved by,

QC Manager QA Manager Head of Quality

10. DEVIATION REPORT............................................................................................................. 16 .

11. REVALIDATION..................................................................................................................... 16
..

12. CLEANING VALIDATION RECOMMENDATION..............................................................16

13. DOCUMENTATION.................................................................................................................16
14. NEXT REVIEW DATE.............................................................................................................16
15. ATTACHMENT....................................................................................................................... 17
16. REVISION HISTORY..............................................................................................................17

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1. PURPOSE
This procedure describes guidelines to perform cleaning validation as authentication of
assurance that after performed cleaning process of production machine would not happened
contamination between products that contact with machine before and after cleaning process.

2. SCOPE
This procedure prevail to cleaning validation of all production machine where it is possibility
happen contamination that is used in PT. Caprifarmindo Laboratories. Validation of cleaning
procedures on required for all equipment, surfaces, and other areas that may have a direct
impact on product quality. To validated all cleaning activities is a difficult undertaking and the
plan requires a matrix to be developed to identity products, equipment, cleaning procedures so
that worst case condition can be selected as a priority for cleaning validation.
It is generally considered that the cleaning activities within a pharmaceutical manufacturing
facility are on going and require a program for verification of the reliability of the procedures.
To reconfirm validated status, some subset of validation must be repeated as specified
intervals, either in the form of an audit or other periodic monitoring.
The most common cleaning procedures to be validated are :
2.1 Cleaning of processing vessels, tanks and transfering equipment.
2.2 Cleaning of filling, compressing, coating, and stripping machine.
2.3 Cleaning of sampling equipment and weighing tools.

3. DEFINITION
3.1 Acceptance Criteria
Specific criteria for results of either process monitoring or a test. Criteria are defined
in a validation or qualification protocol and must be met in order for the process to be
considered validated or the equipment to be qualified.
3.2 Bracketing
Grouping of products base on its water solubility, minimal therapeutic dose, formula
complexity, and concentration by concern about toxicity, characteristic, and adverse
reaction of active ingredient, production frequency, batch size.
3.3 Change Management
A formal system by which qualified representatives of appropriate disciplines review
proposed or actual changes that might affect the validated status of facilities, systems,

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equipment or processes. The intent is to determine the need for action that would
ensure and document that the system is maintained in a validated state.
3.4 Cleaning Validation
Cleaning validation is documented evidence that an approved cleaning procedure will
provide equipment which is suitable for processing medicinal products.
3.5 Cross Contamination
Contamination of a starting material or of a product with another material or product
3.6 Final Rinse
The last rinse of a piece of equipment during the cleaning procedure.
3.7 LD50
Lethal Dose 50 in g/kg animal. The identification of the animal (mouse rat etc.) and
the way of entry (IV, oral etc.) is important.
3.8 Re-Validation
A repeat of the process validation to provide an assurance that changes in the
process/equipment introduced in accordance with change control procedures do not
adversely affect process characteristics and product quality.
3.9 Recovery Study
A laboratory study combining the sampling method and analytical to determine the
quantitative recovery of a specific residue for a defined surface.
3.10Risk Analysis
Method to assess and characterize the critical parameters in the functionality of an
equipment or process.
3.11Risk Management
The systematic application of quality management policies, procedures, and practice
to the tasks of assesing, contolling, comunicating and reviewing risk.
3.12Worst Case
A condition or set of conditions encompassing upper and lower processing limits and
circumstances, within standard operating procedures, which pose the greatest chance
of product or process failure when compared to ideal conditions. Such conditions do
not necessarily induce product or process failure.

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4. REFERENCES
4.1 National Agency of Drugs and Food Administration of Republic of Indonesia. (2012).
Good Manufacturing Practice: Point 12, Qualification and validaion.
4.2 National Agency of Drugs and Food Administration of Republic of Indonesia. (2012).
Guideline on Good Manufacturing Practice: Point 12, Qualification and validaion.
4.3 PIC/S [Pharmaceutical Inspection Convention Pharmaceutical inspection Co-Operation
Scheme]. (2017). Guide to Good Manufacturing Practice for Medical Products. Document
PE 009-13 (Annexes).
4.4 APIC [Active Pharmaceutical Ingredients Commitee], (2016). Guidelines on Aspect of
Cleaning Validation in Active Pharmaceutical Ingredient Plants.
4.5 WHO [Word Health Organization]. (2006). Annex 4 : Supplementary Guidelines on Good
Manufacturing Practices: Validation-Appendix 3: Cleaning Validation TRS No. 937.
4.6 PDA [Parenteral Drug Association]. (2012). Points to Consider for Cleaning Validation.
Thecnical Report No.29.
4.7 PIC/S [Pharmaceutical Inspection Convention Pharmaceutical inspection Co-Operation
Scheme]. (2007) Recommendation on Validation Master Plant, Installation and
Operational Qualification, Non-Sterile Process Validation, Cleaning Validation.
Document PI 006-3.

5. RESPONSIBILITY AND AUTHORITY

5.1 Production Department

Responsible for:
5.1.1 Reviewing the protocol and final report of cleaning validation.
5.1.2 Ensuring that various pieces of equipment are cleaned according to the relevant
SOP.
5.1.3 Supporting production personel during the cleaning validation.
5.1.4 Implementing any agreed recomendations that may be made as results of this
study.
5.1.5 Conducting investigation with validation, QC and QA if there is any out of
specification case.
5.2 QC Department
Responsible for:
5.2.1 Reviewing the protocol and final report of cleaning validation.
5.2.2 Performing of recovery test to product which is selected in bracketing/grouping.

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5.2.3 Validating the analytical method used to analyze traces of active ingredient and
analyze microbial contaminant.
5.2.4 Testing samples according to validated analytical method.
5.2.5 Conducting investigation with production, validation and QA if there is any out
of specification case.
5.3 Validation Department
Responsible for:
5.3.1 Preparing an appropriate approval of validation protocol and validation
report.
5.3.2 Coordinating activities to conduct an affective and reliable cleaning
validation.
5.3.3 Supervising the operation to ensure that everything is done according to this
protocol.
5.3.4 Conducting investigation with production, QC and QA if there is any out of
specification case.
5.4 QA Department
Responsible for:
5.4.1 Approving the protocol and report of cleaning validation.
5.4.2 Ensuring that validation activities conforms with quality assurance
requirements.
5.4.3 Conducting investigation with production, QC and QA if there is any out of
specification case.

6. CLEANING VALIDATION PROCEDURE

6.1 Prepare the bracketing/grouping of cleaning validation and recovery test to determine
the worst case product for cleaning validation and recovery test to make an effective
and efficient cleaning validation and recovery test plan based on scientific evaluation.
Verify recovery test if there is a change in the analysis method. If the recovery test
results are less than 80 %, then cleaning re-validation will be conducted.
6.2 The determination of cleaning validation sampling point based on risk analysis. Risk
analysis for cleaning validation refer to QAS-NS/SOP/CP/020 : Quality Risk
Management and VAL-NS/SOP/CP/002 : Qualification and Validation Standart
Document.
6.3 Prepare the cleaning validation protocol refer to SOP No. VAL-NS/SOP/CP/002 :
Qualification and Validation Standart Document.

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6.4 After the validation protocol has reviewed and approved by related person, do
coordination with related department.
6.5 Perform the cleaning validation execution by refer protocol validation already been
made.
6.6 Perform 3 consecutive batches cleaning validation in the production process facility
purpose.
6.7 Record and documentation the result of execution cleaning validation into cleaning
validation report (cleaning validation report will be refer to SOP No. VAL-
NS/SOP/CP/002 : Qualification and Validation Standart Document).
6.8 Bracketing of cleaning validation perform for every new product transferred from RnD
to plant or every once a year.
6.9 Revalidation of cleaning validation perform if any change in bracketing of cleaning
result and if any change in cleaning procedures.
6.10 Perform the recovery test execution by refer to protocol recovery test already been
made.
6.11 Record and documentation the result of recovery test into recovery test report (recovery
test report will be refer to SOP No. VAL-NS/SOP/CP/002 : Qualification and Validation
Standart Document).

7. EQUIPMENT
All equipments that is needed during validation are :
7.1 Stainless Steel Frame 5x5 cm
7.2 Cotton Swab
7.3 Reaction tube
7.4 Sampling Bottle/Vial 10 mL and 100 mL

8. PROCEDURES

8.1 Bracketing
The cleaning processes of multiple product use equipment in manufacturing facilities are
subject to requirements for cleaning validation. The validation effort could be huge. In
order to minimize the amount of validation required, a worst case approach for the
validation can be used.

The objective of a bracketing project is for the company to demonstrate that it has a
scientific rationale for its worst case rating of the substances in the cleaning validation
program. The first thing to do is to make groups (“bracketing”) from which worst cases

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will later be selected based on the results from the rating. Bracketing procedure will be
performed based on the following procedure:

8.1.1 Collect the solubility in water of each substance in formulation of products using
the specified machine.
8.1.2 Collect the LD50 of each active ingredients in formulation of products using the
specified machine.
8.1.3 Collect the Minimum Therapeutic Dose of each active ingredients in formulation
of products using the specified machine.
8.1.4 Collect the concentration of each active ingredient in formulation of products
using the specified machine.
8.1.5 Give score to each product based on its drug category, solubility, toxicity,
minimum therapeutic dose, concentration of active ingredient, formulation
complexity, batch size, and production frequency.
8.1.6 Choose the worst case product based on the most high score substance from
procedure.

8.2 Sampling Method

There are two methods of sampling that are considered to be acceptable, direct surface
sampling (swab method) and indirect sampling (use of rinse solutions).
8.2.1 Determining Active Ingredient Residue
1. Swab Method

Tools : - Cotton swab

- Test tube

Substance : Sample solvent

For determining active ingredients residue using swab method, the samples are
taken according to the following steps:
a. Use gloves to minimize contamination to the cotton swab,
and surfaces which will be swabbed.
b. Pre-treat the swab in the sample solvent (i.e. purified water)
by saturate the swab with solvent in the test tube.
c. Squeeze the swab in to the wall of test tube twice. Do not let
the swab too sweat.

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d. Swab the surface firmly on sampling point and evenly in

back and forth motion (one stroke backward and one stroke forward)
 Swab horizontally with one side of the swab
 Swab vertically with the other side of the swab
 Swabbing must be done consistently with remain direction
 Sampling point area to swab is defined from critical area calculation
and is fitted with equipment size.

 Swabbing must be done consistently with remain direction.

 Sampling point area to swab is defined from critical area
calculation and is fitted with equipment size.
e. Put the cotton swab into the test tube and close the tube, label
with sample position, date, etc.
f. Send the samples to the QC.
2. Rinse Method
The Procedure of final rinse method:
a. Rinse the cleaned equipment with purified water.
b. Collect approximately 200 ml from the final rinse into a clean glass
bottle and close the bottle with the lid, and label.
c. Send the samples to QC.
8.2.2 Determining Microbial Contaminant
1. Swab Method
Sampling using swab method for determination of microbiological
residue samples are taken according to the following steps:

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a. Use sterile gloves to minimize contamination to the cotton swab,

and surfaces which will be swabbed.
b. Pre-treat the swab in the sample with sterile purified water by
saturate the swab with sterile purified water in the test tube.
c. Squeeze the swab in to the wall of test tube twice. Do not let the
swab too sweat.
d. Swab the surface firmly on sampling point and evenly in back and
forth motion (one stroke backward and one stroke forward)
e. Swab vertically with the other side of the swab
 Swabbing must be done consistently with remain direction
 Sampling point area to swab is defined from critical area
calculation and is fitted with equipment size.

f. Swab the cotton swab into the media in petri disc. Close the petri
disc, label with sample position, date, etc
g. Send the samples to the QC.
2. Rinse Method
For determining microbial contaminant, the samples are taken according to
the following procedure:
a. Rinse the cleaned equipment with Purified water.
b. Collect approximately 2 x 100 mL from the final rinse into a clean and
sterile glass bottle with lid, and label.
c. Send the samples to QC.

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8.2.3 Determining Detergent Residue

For determining detergent residue, the samples are taken according to the
following procedure (final rinse method):
1. Rinse the cleaned equipment with Purified water.
2. Collect approximately 200 mL the final rinse into a clean amber glass
bottle and close the bottle with the lid and label correctly.
3. Send the samples to QC.

8.3 Acceptance Criteria/ Residue Limit Determination

The following abbreviations will be available in establishment of acceptance criteria for
chemical residue:
MARP : Maximal Allowed chemical Residue (previous product) per swab
[mg] per swabbed area of 25 cm2
MTDP : Minimal Theurapeutic Dose (previous product) [mg]
SF : Safety Factor = 0.001
[= pharmacological safety factor 0.01 x internal safety factor 0.1]
MBSf : Minimal Batch Size (following product) [mg]
NDFf : Number of Daily Intake (following product)
Wf : Weight (following product)
ASwab : Surface area swabbed [25/100/400 cm2]
ATot : Total active contact surface area of the equipment [cm2]
(To obtain total active contact surface area (ATot) of the
equipment depends on the geometry of the surface having
direct contact with product.)
R : 10 mg / 106 mg
ARinse : Surface area rinse [cm2]
VRinse : Volume used for rinsing [mL]
The visual inspection criterion must be included in every cleaning validation protocol.

The other criterions must be calculated, evaluated and selected to ensure that any
carry-over product residue meets the all criterion (select the strictest acceptance
criteria):

8.3.1 Acceptance Criteria for Swab Method

For swab method, three acceptance criteria are defined:

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1. Visual Inspection
The acceptance criteria for visual inspection is a mandatory and shall
always be applied.
Acceptance criteria:
“No quantity of any residue will be visible on the equipment after
cleaning procedures are performed and on the sampling swab after
swabbing sampling are performed”.
2. Chemical Residue
Choose the most stringent criterion from dose criterion, surface criterion,
and 10 ppm criterion as acceptance criteria. The recovery test for swab
method is should be greater than 80 %.
a. Dose Criterion
Not more than 0.001 dose of product residue will be appear in the
maximum daily dose of another product.
Equation:

MTD P  SF  MBSf A Swab

MAR P   ___ (mg/cm 2 area swabbed)
Wf  NDFf  A Tot

b. Surface Criterion
Equation:

MTD P  SF  A Swab
MAR P  2
 ___ (mg/cm2 area swabbed
1 cm

c. 10 ppm Criterion
Not more than 10 ppm of product residue will appear in another
product.

Equation:

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R  MBSf  A Swab
MAR P   ___(mg/cm 2 area swabbed )
A tot

d. Microbiology Limit
Not more than 50 CFU / 25 cm2 area swabbed.

8.3.2 Acceptance Criteria for Rinse Method

For rinse method, three acceptance criteria are defined:
(could be seen at next page)

1. Visual Inspection
The acceptance criteria for visual inspection is a mandatory and shall
always be applied.
Acceptance criteria:
“No quantity of residue will be visible on the equipment after cleaning
procedures are performed and in the last rinsing solution which taken as
sample”.
2. Chemical Residue
Choose the most stringent criterion from dose criterion, surface criterion,
and 10 ppm criterion as acceptance criteria.
a. Dose Criterion
Not more than 0.001 dose of any product will be appear in the
maximum daily dose of another product.

Equation:

MTD P  SF  MBSf  A Rinse

MAR P   ___ (mg/mL sample volume)
Wf  NDFf  A Tot  VRinse

b. Surface Criterion

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Equation:

MTD P  SF  A Rinse
MAR P   ___ (mg/mL sample volume)
1 cm 2  VRinse

c. 10 ppm Criterion
Not more than 10 ppm of product residue will appear in another
product.

Equation:

R  MBSf  A Rinse
MAR P   ___(mg/mL sample volume)
A tot  VRinse

d. Microbiology Limit
Rinse water microbiological analysis result must be under 100
CFU/ml (volume of rinse sample).

8.4 Sampling Plan

8.4.1 According to Risk Analysis, describes/define the critical points using
drawing/picture or diagram and named as:
a. Chemical Test: C1, C2, C3, etc.
b. Microbiological Test: M1, M2, M3, etc.
c. Detergent Residual Test: FRS

8.4.2 Take the samples at the critical point as described at point “a” (above) according to
the chosen sampling method (point 8.2)

8.5 Assay Method

8.5.1 Basic requirements of analytical method for cleaning validation:
1. Sensitivity/detection level of the method
2. Validation according to USP, ICH requirements
3. Recovery study challenge
4. Practical and rapid method
8.5.2 Methods that can be used:
1. Chromatographic methods
2. Spectrophotometric methods (UV/VIS, IR)
3. Total Organic Carbon (TOC)

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4. pH and Conductivity
5. ELISA and Electrophoresis

8.6 Action Taken When Out of Limit Result Found

8.6.1 Check the testing procedures:
1. Check the relevant instrument
2. Check the lab. procedure
3. Check the sampling procedure
4. Check the cleaning procedure
8.6.2 Take action on basis of discussing among Quality Management and Production
Management
8.6.3 Write re-validation plan and perform re-validation of all steps where shortcoming
have been identified

8.7 Monitoring Validated Cleaning Process

8.7.1 For automated process, monitoring should included items which are probably
already measured as part of the process automation. These parameters include
times, temperatures, flow rates, pressures and cleaning agent concentration. It may
also include measurements of TOC, conductivity and/or bioburden of the final
rinse water. It includes visual examination of the cleaned equipment.

8.7.2 For manual cleaning, parameters that may be monitored include visual examination
during manual cleaning, times, temperatures, cleaning agent concentration,
operators ability (training programme).

8.8 Change Management

8.8.1 All changes that may affect product quality or reproducibility of the cleaning
process should be formally requested, documented and accepted. The impact of the
change should be evaluated. The need for and the extent of revalidation should be
determined.
8.8.2 Procedures of change management can be seen in the SOP No.
QAS-NS/SOP/CP/012.

9. EVALUATION
9.1 Enclosed all data and graphics during cleaning validation execution.
9.2 Analysis data during cleaning validation execution.
9.3 Compare actual data and acceptence criteria.

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10. DEVIATION REPORT

Prepare the deviation report, attach data or justification evidence.

11. REVALIDATION
Revalidation should be considered under the following circumstances:
Change of:
11.1 Cleaning method
11.2 Cleaning agent
11.3 Cleaning procedures
11.4 Product (bracketing/grouping)
11.5 Process equipment
Cleaning validation will be conducted for 3 consecutive batches. Specifically the scope of the
plan applies to cleaning validation of processing equipment.

12. CLEANING VALIDATION RECOMMENDATION

12.1 Validation recommendation is a system tool (form recommendation) that provides
advice or recommendation related things about cleaning result and used as guidance for
related department to change or adjust the cleaning until the Cleaning Validation Report
approved.
12.2 Validation will be created after third batch cleaning validation done.
12.3 Validation recommendation is not subtitute for Cleaning Validation Report.
12.4 Recommendation execute for cleaning process, based on document no. VAL-
LV/FOR/CP/001. All recommendation has been monitoring at e-logbook “ Monitoring
of Recommendation Cleaning Validation “. No. Document : VAL-LV/FOR/CP/006 and
every recommendation should be monitored by Person In Charge.

13. DOCUMENTATION
All the observation result is documented into cleaning validation report.
Cleaning validation report, covers:
13.1 Sampling Plan.
13.2 Determination of Acceptance Criteria.
13.3 Cleaning Validation Execution Results Form.
13.4 SOP of Cleaning Related.

14. NEXT REVIEW DATE

Three years after effective date or as required.

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15. ATTACHMENT
15.1 Form monitoring of Recommendation Cleaning Validation (VAL-LV/FOR/CP/006).

16. REVISION HISTORY

Revision
Date Description Originator
No
00 20 July 2005 Initial Release Lyna Nurhayati

 Change the document name from Reni Kartika Dewi

01 20 December
Working Instruction into Standard
2010
Operating Procedure.
 Change the document number from
VAL-LV/SPB/CP/001 into VAL-
LV/SOP/CP/001.
02 18 November Periodic Review Frisky Almuksiti
2013
 Change the Scope of the document
03 16 June 2014 Dyah Afritasari A.
(Section 2) to give more detailed
information.
 Added new terms in the Definitions
(Section 3).
 Updated the reference ”Petunjuk
Operasional Cara Pembuatan Obat
Yang Baik, Badan POM” from
edition 2012 to edition 2013.
 Breakdown the responsibilites per
department for more detailed
information (Section 5).
 Rename the section “Preparing The
Cleaning Validation Protocol” to
“Documentation” in Section 6.3.
 Add the Validation Standard
Document SOP as reference in
section 6.3 point ‘d’.
 Add the acceptance limit of recovery
test.
 Change the acceptance criteria in
section 6.5 based on sampling
method.

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Reviewed, Reviewed, Reviewed, Reviewed, Approved,

Revision
Date Description Originator
No

 Re-layout and re-numbering all

section in this document.
 Change the person who approving
Production Equipment Cleaning
Validation SOP from QA Manager to
Head of Quality.
 Added
Includenew terms
Solid in the Definitions
Production Manager,
04 23 June 2017 Asep Dwi Permana
(Section
Liquid &3).Semisolid Production
 Add New QC
Manager, reference : Journal
Manager, and QAOf
Validation
Manager for Tecnology.
reviewing“Cleaning
Production
Validation
EquipmentFactors Affecting
Cleaning Validation SOP.
Recovery”, 2009.
 Change the footer from
\\Cimareme\Release\Capri\Validation
\SOP\Val-LV/SOP/CP/001-Cleaning
Validation - R04.doc into
\\Cimareme\Release\Capri
\VAL\SOP\VAL-LV.SOP.CP.001-
Cleaning Validation - R04.doc
 Added of Point 6.2.3 Collect at
05 09 August Asep Dwi Permana
Minimum Therapeutic Dose of each
2017 active ingredients in formulation of
products using the specified machine,
at point 6.2 Bracketing/Grouping and
Worst Case Rating
 Update Point 1. Purpose with the
06 12 February Asep Dwi Permana
new format
2018
 Update Point 2. Scope with the new
format
 Added Definitions at point 3.
 Update Point 4. References used
 Update Point 5. Responsibility And
Authority
 Update point 6. Cleaning Validation
Procedure

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Revision
Date Description Originator
No
 Added point 7. Equipment
 Added point 9. Evaluation
 Added point 10. Deviation Report
 Added point 12. Cleaning Validation
Recommendation.
 Added point 13. Documentation
 Added point 15. Attachment

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