Title: Cleaning Validation

Report for
-------------- to -------------------
 :ATTACHMENTS
Description Attachment/Appendix
Sampling Points of --------------------- Machine Attachment No.: 1
Training Certificates Attachment No.:2
The authority & responsibility matrix, In-Process Quality Control,
Attachment No.:3
Physico-Chemical Lab., and Microbiological Lab.
Rinse Analysis Reports, Run 1 Attachment No.:4
Swab Analysis Reports, Run 1 Attachment No.:5
Rinse Analysis Reports, Run 2 Attachment No.:6
Swab Analysis Reports, Run 2 Attachment No.:7
Rinse Analysis Reports, Run 3 Attachment No.:8
Swab Analysis Reports, Run 3 Attachment No.:9
Results of Microbiological tests, Swab Sampling Attachment No.:10
Results of Microbiological tests, Rinse Sampling Attachment No.:11
Clean Hold Time, Run 1 Attachment No.:12
Clean Hold Time, Run 2 Attachment No.:13
Clean Hold Time, Run 3 Attachment No.:14

Table of Contents
No. Subject Page
1 Objective 4
2 Scope 4
 Description of Equipment, Products, and Cleaning Process
3 4
Responsibility
4 5
Description of the Cleaning Process
5 5
Cleansing agents
6 7
Worst Case Determination
7 7
Determination of Acceptable limits for products
8 8
Microbiology
9 8
Training Record Verification
10 9
Verification of Documents
11 9
12 Procedure 10
Reports
13 11
14 Related Documents 44
15 References 44

1. Objective
The objective of this report is to demonstrate that the cleaning procedures which are used will
successfully and consistently reduce the level of residues to a predetermined level of acceptability, so
as to prevent contamination (product or cleaning process related) from adversely affecting the safety
and quality of the next product manufactured.
 2. Scope
The scope of this report concerns the different equipments and areas which are directly in contact to
the ------------ material and are supposed to be contaminated by different ways, so the below tests
should be done:
Type of Test Number of Test Runs
Visual Inspection 3
Test for residual product 3
Test for microbiological contamination 3

3. Description of Equipment, Products, and Cleaning Process

Equipment Train, Products, Process Description for ------------------ Lines, and Cleaning Process are
described in Cleaning Validation Protocol for -------------------- Machine, Code No.: --------------------.

4. Responsibility
The following personnel are responsible for the execution of this report:
No. Cleaning/Testing Done by Recorded on Checked by
Equipment usage/ Production
1 Equipment Cleaning Machine Operator
Cleaning logbook supervisor
Head of Qualification and
2 Visual Inspection Analytical logbook IPQC
Validation/QA Expert
Machine operator/ Head of
3 Rinse/Swab Sample Qualification and Sampling sheet QA Expert/IPQC
Validation/QA Expert/ IPQC
Head of Qualification and
4 MAC Validation/ QA Expert/QC Analytical logbook QA Manager
analyst

5 Bio-burden Microbiologist Analytical logbook QC Manager

Head of Qualification and QA Manager,

6 Rinse recovery challenge test Analytical logbook
Validation/QC analyst QC Manager

5. Description of the Sampling Process

 Sampling Technique
In ------------- Pharmaceutical Company both indirect sampling (rinse test) and direct sampling
(swab test) techniques are used to take samples from the ------------ Machine according to "Cleaning
Validation Protocol for ----------- Machine", Code No.: ------------------- and "SOP for Sampling
techniques for cleaning validation" Code No.: ------------------.
 The figure of ----------- Machine is attached to Attachment No.:1, Figure: 1 of ---
 The figure of Sampling Points of ------------ Machine are attached to Attachment No.:1,
Figure: 2 of ---- to Figure: ---- of ----
 Sampling Technique and Difficult to clean parts are mentioned in the following table.
 Sampling Technique

Sample Area/Quantity
Sampling Criteria

Type of Sample
Sampling
Sampling

Location/Name Reference
Location/ID

Difficult to clean (D)

Normal(N)

Rinse (R)
Swab (S)

Cm2

mL

6. Cleansing agents:
The cleansing agent is selected mainly in accordance with the solubility properties of the worst
case product. These properties are determined not only by the active pharmaceutical ingredient -
possibly present in small quantities - but also by all the substances in the formulation.
Selection of cleansing agents is described in Cleaning Validation Protocol for -------------- Machine,
Code No.: ----------------------.
In ------------Pharmaceutical Company, Ethanol is used as solvent while exchanging products from
------------------ to --------------------- for cleaning the equipments.
are
Cleansing agents used during the cleaning process.
are not

7. Worst Case Determination

The worst case related to product is the one containing most insoluble active ingredient, with lowest
lethal dose or with highest therapeutic dose. Worst case determination is described in Cleaning
Validation Protocol for -------------------- Machine, Code No.: --------------------.

LINE A
 Product Solubility in Dosage
No. Max Dose Min Dose Potency LD 50
Name water Form

Solubility:
LD50:
Potency:
Min Dose:

Worst Cases: ------------------ > ---------------- > -------------

8. Determination of Acceptable limits for products

−−−−−−−−−−¿ ¿ line,
For changing product from -------------------- to ----------------------- in −−−−−−−−−−−¿ ¿
the amount of Maximum Acceptable Carry Over (MACO) is calculated in Cleaning Validation
Protocol for ------------------------------- Machine Code No.: -----------------

Sterile line
Swab limits(mg/swab area) Rinse limits (ppm)
ppm 10 Toxicity Dose ppm 10 Toxicity Dose Line A .No
criterion criterion criterion criterion criterion criterion
Note 1: According to the calculations that are mentioned above, the maximum value is chosen
(stricter limit) for rinse and swab to decrease risk. A comparison of the limits shows that the
--------------------
Criterion must be used for subsequent product (--------------------).
Note 2: For product non-contact surface, Not more than 1/1000 th of any product will appear in
another product.
9. Microbiology
Microbiology, Determination of the microbial status, Sampling instructions, Sampling recovery,
Acceptance criteria, Storage condition of clean surface & equipment, Holding Time, Dirty Hold
Time, and Clean Hold Time are described in Cleaning Validation Protocol for
----------------------Machine, Code No.: -------------------------.

10. Training Record Verification

In ------------------------------ Pharmaceutical Company all of the personnel who take part in cleaning
process are trained according to the Training SOP, Code No.:-------------------------- and "Major
Cleaning of -------------- Machine while exchanging products" SOP, Code No.:
--------------------------.
The following staff found trained on cleaning of the equipment and The analyst trained on standard
test methods according to SOP for Training, Code No.:-----------------------.
All of the Training Certificates are attached to Attachment No.: -----
All of the personnel who are responsible for the analysis are listed in the following documents,
Attachment No.: -------------------
 The authority & responsibility matrix(In-Process Quality Control Lab.), ---------------------
 The authority & responsibility matrix(Physico-Chemical Lab.), --------------------
 The authority & responsibility matrix(Microbiological Lab.), -------------------------

No. Line Dep. Name Sign. Date

 11. Verification of Documents
In ----------------------- Pharmaceutical Company, all of the SOPs are according to the master list Code
No.:--------------------------------------

12. Procedure
12.1. Cleaning Procedure
 Gross cleaning by vacuum and non-lint wiper.
 All the machine parts which come into direct contact with the product are cleaned and rinsed
with water according to "SOP for Major Cleaning of ------------------- Machine while exchanging
product" Code No -------------------------- and "SOP for Minor Cleaning of --------------------
Machine at the end of working day" Code No.: -------------------------------.

12.2. Sampling
Samples are taken by rinsing and swabbing techniques according to "SOP for Sampling techniques
for cleaning validation" Code No.: -----------------------. And the residual amounts are calculated in
relation to surface area. The presence of the machine operating team to ensure accessibility to the
hardest place to clean in the machine product direct contact surface is important.

12.3. Rinse and swab Analysis

Analysis of the rinse and swabs takes place according to analytical monograph.
Cleaning procedure, sampling and analysis must be repeated for 3 consecutive runs.

12.4. Calculation
Recovery calculation:
Recovery calculation should be carried out by spiking a known quantity of the active material on 25
cm2 area of the machine, and swabbing this area and analysis of the product according to procedure
analytical monograph of product A and calculating the peak area for the standard and test materials
using the following equation.

Recovery:

peak areaof test Ws

%Recovery= × ×100
peak area of standard Wt
Where: Ws, Wt amount in mg of working standard used in the preparation of the standard and test
solution, respectively.

Swab calculation:

Conc . mg peak areaof test mg Z 100

( )=
swab swab area peak area of standard
×conc . of STD
L
× ( )
×
1000 Recovery

Where: Z: Dilution volume of the swab (ml)

Rinse calculation:

Residue mg peak area of test mg 100

Rinse ( )
L
=
peak area of standard
× conc . of STD
L ( )
×
Recovery

13. Reports
The reports are documented in the following attachments. Any deviation or out of specification
reports must be reported and fully investigated.
According to 21 CFR 211.194(a)(2) , users of analytical methods described in USP-NF are not
required to validate the accuracy and reliability of these methods, but merely verify their suitability
under actual conditions of use.
Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposals for
adoption of new or revised compendial analytical procedures be supported by sufficient laboratory
data to document their validity.
The ICH documents give guidance on the necessity for revalidation in the following circumstances:
changes in the synthesis of the drug substance; changes in the composition of the drug product; and
changes in the analytical procedure according to the following guidelines:
ICH Q2A Guideline, Validation of Analytical Methods Definitions and Terminology
ICH Q2B Guideline, Validation of Analytical Procedures: Methodology
Analytical Performance Characteristics are Accuracy, Precision, Specificity, Detection Limit,
Quantitation Limit, Linearity, Range, and Robustness.
 13.1. Cleaning Validation Report 1
13.1.1. Visual Inspection

Visual Inspection, Run 1

Product Name

Product Chemical Structure

Product Formulation
Batch No.
Manufacturing Date
Active Ingredient
Next Product to Be Manufactured in the Same Equipment
Cleaning Date
Cleaning SOP No.
Sampling Technique
Test Method Reference
Cleaning Sample Analysis Date/Time
Cleaning Sample Analysis Result

The cleaned equipment must be visually inspected for cleanliness. No residues may be apparent this
inspection. The inspection must be carried out according to the following checklist:

Check Item and Description

.Deviation no Comment .No
Fail Pass
Machine surface 1
Turn table 2
Conveyer top surface 3
Powder hopper 4
Disk 5
Laminar 6

:Authorized By :Approved By :Performed by

:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature

13.1.2. Testing for Residual Products

13.1.2.1. Rinse Analysis Reports
Rinse Analysis Reports, Run 1
Product A: B. No.: Dosage:
Product B: B. No.: Dosage:
Date: Attachment No.: MACO(ppm):
Sampling Criteria
Analysis
Sample
No Sample Sampling Difficul Quantit HPLC
. Reference Final Result
ID Location/Name t to Normal y Result
clean (N) (ml) (Sample)
(D) Pas
(ppm) Fail
s
ND: Not Detected

The results are attached to Attachment No.:4

Comment:

Deviation:
 :Authorized By :Approved By :Performed by
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature

13.1.2.2. Swab Analysis Reports

Swab Analysis Reports, Run 1
Product A: B. No.: Dosage:
Product B: B. No.: Dosage:
Date: Attachment No.: MACO(ppm)
Sampling Criteria
Analysis

Sample
Sample Sampling Difficul HPLC
.No Area Reference Final Result
ID Location/Name t to Normal Result
(Cm2)
clean (N) (Sample)
(D) Pas
(ppm) Fail
s
HPLC Result (Blank):

The results are attached to Attachment No.:

Comment:

Deviation:
 :Authorized By :Approved By :Performed by
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature

13.2. Cleaning Validation Report 2

13.2.1. Visual Inspection

Visual Inspection, Run 2
Product Name
Product Chemical Structure
Product Formulation
Batch No.
Manufacturing Date
Active Ingredient
Next Product to Be Manufactured in the Same Equipment
Cleaning Date
Cleaning SOP No.
Sampling Technique
Test Method Reference
Cleaning Sample Analysis Date/Time
Cleaning Sample Analysis Result

The cleaned equipment must be visually inspected for cleanliness. No residues may be apparent this
inspection. The inspection must be carried out according to the following checklist:

Commen Check Item and Description

.Deviation no .No
t Fail Pass
Machine surface 1
Turn table 2
Conveyer top surface 3
 Powder hopper 4
Disk 5
Laminar 6

:Authorized By :Approved By :Performed by

:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature

13.2.2. Testing for Residual Products

13.2.2.1. Rinse Analysis Reports

Rinse Analysis Reports, Run 2
Product A: B. No.: Dosage:
Product B: B. No.: Dosage:
Date: Attachment No.: MACO(ppm)
Sampling Criteria
Analysis
Sample
No Sample Sampling Difficul Quantit HPLC
. Reference Final Result
ID Location/Name t to Normal y Result
clean (N) (ml) (Sample)
(D) Pas
(ppm) Fail
s
HPLC Result (Blank):

The results are attached to Attachment No.:

Comment:

Deviation:

:Authorized By :Approved By :Performed by

:Name :Name :Name
:Post :Post :Post
 :Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature

13.2.2.2. Swab Analysis Reports

Swab Analysis Reports, Run 2

Product A: B. No.: Dosage:
Product B: B. No.: Dosage:
Date: Attachment No.: MACO(ppm)
Sampling Criteria
Analysis

Sample
Sample Sampling Difficul HPLC
.No Area Reference Final Result
ID Location/Name t to Normal Result
(Cm2)
clean (N) (Sample)
(D) Pas
(ppm) Fail
s
HPLC Result (Blank):

The results are attached to Attachment No.:

Comment:

Deviation:

:Authorized By :Approved By :Performed by

:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
 :Date &Signature :Date &Signature :Date &Signature

13.3. Cleaning Validation Report 3

13.3.1. Visual Inspection
Visual Inspection, Run 3
Product Name
Product Chemical Structure
Product Formulation
Batch No.
Manufacturing Date
Active Ingredient
Next Product to Be Manufactured in the Same Equipment
Cleaning Date
Cleaning SOP No.
Sampling Technique
Test Method Reference
Cleaning Sample Analysis Date/Time
Cleaning Sample Analysis Result

The cleaned equipment must be visually inspected for cleanliness. No residues may be apparent this
inspection. The inspection must be carried out according to the following checklist:

Check Item and Description

.Deviation no Comment .No
Fail Pass
Machine surface 1
Turn table 2
Conveyer top surface 3
Powder hopper 4
Disk 5
Laminar 6

:Authorized By :Approved By :Performed by

:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
 :Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature

13.3.2. Testing for Residual Products

13.3.2.1. Rinse Analysis Reports
Rinse Analysis Reports, Run 3
Product A: B. No.: Dosage:
Product B: B. No.: Dosage:
Date: Attachment No.: MACO(ppm)
Sampling Criteria
Analysis
Sample
No Sample Sampling Difficul Quantit HPLC
. Reference Final Result
ID Location/Name t to Normal y Result
clean (N) (ml) (Sample)
(D) Pas
(ppm) Fail
s
HPLC Result (Blank):

The results are attached to Attachment No.:

Comment:

Deviation:

:Authorized By :Approved By :Performed by

:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
 13.3.2.2. Swab Analysis Reports
Swab Analysis Reports, Run 3
Product A: B. No.: Dosage:
Product B: B. No.: Dosage:
Date: Attachment No.: MACO(ppm)
Sampling Criteria
Analysis

Sample
Sample Sampling Difficul HPLC
.No Area Reference Final Result
ID Location/Name t to Normal Result
(Cm2)
clean (N) (Sample)
(D) Pas
(ppm) Fail
s

HPLC Result (Blank):

The results are attached to Attachment No.:

Comment:

Deviation:

:Authorized By :Approved By :Performed by

:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
 13.4. Reference Method:

The analytical method is done according to USP 35-NF 30

HPLC Conditions for ----------------- for -----------------

Column Type
Column Oven Temperature
Mobile Phase
Elution Program
Flow Rate
Detector
Wavelength
Injection Volume
Retention Time
Run Time

13.5. Recovery studies:

For analytical procedures using swab or rinse sampling, recovery is the percent of the known amount
of target residue spiked onto a coupon that is actually measured in the analytical procedure. Ideally,
recoveries should be in the 80-120 percent range. The amount spiked should correspond to the
amount found near the acceptance limit for that residue. Recovery of the target residue by the swab
sampling procedure must be demonstrated. For microbiological sampling, the swab is desorbed into a
buffer solution, and a plate count is done.

1×LOQ: Electropolished stainless steel (#316) standard plates (completely the same as ---------
machine surfaces) were contaminated with 0.1 mL of solution containing 2.0 ppm of -------------------
standard solution.

2×LOQ: Electropolished stainless steel (#316) standard plates (completely the same as -------------
machine surfaces) were contaminated with 0.2 mL of solution containing 2.0 ppm of -------------------
standard solution.

4×LOQ: Electropolished stainless steel (#316) standard plates (completely the same as
-------------------- machine surfaces) were contaminated with 0.4 mL of solution containing 2.0 ppm of
----------------- standard solution.

The swabs were previously humidified with mobile phase. In brief, swab was passed on the board in
zig-zag manner from right to left, returning from left to right, from top to bottom and returning
upwards. For recovery of residues removed from plate, the sampling swab was immersed in 2.0 mL
of mobile phase and the solution with swab immersed was put in ultrasonication bath for 10 min. The
resulting solutions were injected into the chromatographic system and the results are shown in below
table:

Recover Averag Area Descriptio

Concentration
)%( y e (AU) n
Direct
ppm 0.1
Injection
×1
Spiked Volume:
LOQ
0.1 ml (2.0 ppm) Recovery
:Solvent Volume of Surface
ml 2

Direct
ppm 0.2
Injection
×2
Spiked Volume:
LOQ
0.2 ml (2.0 ppm) Recovery
:Solvent Volume of Surface
ml 2

Direct
ppm 0.4
Injection
×4
Spiked Volume:
LOQ
0.4 ml (2.0 ppm) Recovery
:Solvent Volume of Surface
ml 2
Average recovery
 13.6. Validation Assessment

13.6.1. Results
Results of visual checks, residual products, and microbiological tests are described below.

13.6.1.1. Results of visual check

satisfied
The visual inspection of the cleaned surfaces the acceptance criteria in the Run No.:1
did n' t satisfy

satisfied
The visual inspection of the cleaned surfaces the acceptance criteria in the Run No.:2
did n' t satisfy

satisfied
The visual inspection of the cleaned surfaces the acceptance criteria in the Run No.:3
did n' t satisfy

13.6.1.2. Results of residual product

Testing for residual product was carried out in the form of the rinse and swab test. This involved swab
sampling of Powder hopper, Hopper joints, Plastic Connection, Powder Inlet, Mixer, Disk, Dosing
Wheel, Dosing Pistons, Control Block, Damper, and Connections.
The rinse test was carried out across the entire product contact surface.

was
For rinse test the acceptance criteria met in the Run No.:1
wasn ' t

was
For swab test the acceptance criteria met in the Run No.:1
wasn ' t

was
For rinse test the acceptance criteria met in the Run No.:2
wasn ' t

was
For swab test the acceptance criteria met in the Run No.:2
wasn ' t

was
For rinse test the acceptance criteria met in the Run No.:3
wasn ' t

was
For swab test the acceptance criteria met in the Run No.:3
wasn ' t
 13.6.1.3. Results of Microbiological tests
Results of microbial examination is provided confidence that cleaning and storage of equipment
dose not allow microbial proliferation as mentioned in the following tables:

Swab Sampling Microbiological result of surface cleanliness

Total Microbial

Corresponds

Corresponds
CFU/25cm2

Acceptance Criteria

Dose not
Sampling Location

Count
Sample

R R R R R R
Run 1

Run 1

Run 1
u u u u u u
n n n n n n
The results are attached to Attachment No.:

Comment:

Deviation:

:Performed by :Approved By :Authorized By

:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
Microbiological result of surface cleanliness
Rinse
Sampling
Acceptance Criteria < 10 CFU/100ml

Total Bacterial

Corresponds

Corresponds
Dose not
Sampling Location

Count
Sample

R
Run 1

Run 1

Run 1
Run Ru Ru Ru u Ru
2 n3 n2 n3 n n3
2
The results are attached to Attachment No.:

Comment:

Deviation:

:Authorized By :Approved By :Performed by

:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
13.7. Holding Times
In ------------------- Pharmaceutical company the concept of holding times is mentioned in "Cleaning
Validation Protocol for ------------------ Machine", Code No.: ---------------------

13.7.1. Clean Hold Time

After cleaning has been performed, the equipment will only be considered clean for a maximum
identified time. If the equipment is left unused for more than this time, it must be partially cleaned
again prior to use.
Daily microbiological test have to be done for assessment of clean hold time after cleaning of three
trial batches. Up to that time microbiological test result meets the specification, reusing of
equipments has no restriction. When out of specification results appear, clean hold time is finished.
Test results for clean hold time assessment is attached the report.
 Run 1
Result of Clean Hold Time
(Total Microbial Count CFU/25cm2)
Days
Samplin 1st 2nd 3th 4th 5th 6th 7th 8th
g
….AMTime

….AMTime

….AMTime

….AMTime

….AMTime

….AMTime

….AMTime

….AMTime
….PMTime

….PMTime

….PMTime

….PMTime

….PMTime

….PMTime

….PMTime

….PMTime
Locatio
n

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

The results are attached to Attachment No.:12

Comment:
Deviation:

:Authorized By :Approved By :Performed by

:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
Run 2
Result of Clean Hold Time
(Total Microbial Count CFU/25cm2)
Days
8th 7th 6th 5th 4th 3th 2nd 1st Samplin
g
Location

1
2
3
4
5
6
7
 8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

The results are attached to Attachment No.:13

Comment:

Deviation:
 :Performed by :Approved By :Authorized By
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
Run 3
Result of Clean Hold Time
(Total Microbial Count CFU/25cm2)
Days
1st 2nd 3th 4th 5th 6th 7th 8th
Samplin
g
….AMTime

….AMTime

….AMTime

….AMTime

….AMTime

….AMTime

….AMTime

….AMTime
….PMTime

….PMTime

….PMTime

….PMTime

….PMTime

….PMTime

….PMTime

….PMTime
Location

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
The results are attached to Attachment No.:

Comment:

Deviation:

:Authorized By :Approved By :Performed by

:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
:Name :Name :Name
:Post :Post :Post
:Date &Signature :Date &Signature :Date &Signature
13.7.2. Dirty Hold Time
Dirty hold time is the maximum allowable holding time for the uncleaned production equipment until
complete cleaning. In ----------------------- Pharmaceutical company equipment need to be cleaned
Immediately or as soon as possible after use, due to the production schedule by responsible personnel
according the SOPs.

13.8. Observation and Corrective Actions

meet
Observations are showed that cleaning procedure the requirements,
doe s' t meet
is
and corrective action required in this section.
isn' t

13.9. Summary

According to the results, cleaning procedure for changing product in ------------------ line from
meet
----------------- to ------------------- the requirements.
doe s' t meet
 13.10. Final cleaning validation report

Cleaning validation report for --------------- to ---------------

Material Name:
Material Solubility:
Detergent used:
The ----------------- Machine was cleaned as per SOP for "Major Cleaning of -----------------------
Machine while exchanging products" SOP: Code No.: --------------------------
Machine parts which are in direct contact with the product and need to be cleaned: All of them are
removable and are listed in Chapter 5, Description of the Sampling Process, Sampling Technique
Table.
The swab samples were taken as per "SOP for sampling techniques for cleaning validation" Code
No.: ---------------------------
The %Recovery from machine surface is about:…
The swab samples analyzed by HPLC according to USP ---------------NF ----------------
The obtained results are as the following table:

Rinse Test
Acceptance Criterion Acceptance Criterion Acceptance Criterion
….ppm ….ppm ….ppm
After the first validation After the second validation After the third validation
B. No.: B. No.: B. No.:
Final Result Final Result Final Result
Pass Fail Pass Fail Pass Fail

Acceptance Criterion Acceptance Criterion Acceptance Criterion

….(mg/swab area) ….(mg/swab area) ….(mg/swab area)
After the first validation After the second validation After the third validation
B. No.: B. No.: B. No.:
Final Result Final Result Final Result
Pass Fail Pass Fail Pass Fail
 13.11. Deviation Report

Deviation Description

Detected by: Date:

Assessment and Remediation Activities to Achieve Compliance
Critical Deviation Non Critical Deviation

Specified by: Date:

Corrective Action Description
Critical Deviation Non Critical Deviation

Executed by: Date:

Re-Inspection/Re-Test Results of Corrective Action

□CA complies □CA doesn't comply

Executed by: Date:
Approved by: Date:
 14. Related Documents
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