Cleaning Validation Protocol

Company Name Company Logo

Document No. : CVP/ Product Code-XXX/NN *
Effective Date Revision No. :

Cleaning Validation Protocol

Name of Product:
Stage:
Product Code:
Plant:

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 Cleaning Validation Protocol
Company Name Company Logo
Document No. : CVP/ Product Code-XXX/NN *
Effective Date Revision No. :

Sr. No. Table of Contents Page No.

1. Background
2. Purpose
3. Scope
4. Approval Signatures
5. Responsibilities
6. Sampling Procedure
6.1 Swab Sample
6.2 Rinse Sample
6.3 Microbial Testing
7. Testing Procedure
8. Acceptance Criteria
9. Deviations
10. Revalidation
11. Abbreviation
12. Annexures

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 Cleaning Validation Protocol
Company Name Company Logo
Document No. : CVP/ Product Code-XXX/NN *
Effective Date Revision No. :

1.0 Background:

Dispensing Equipment is routinely cleaned after Locyst Tablet (or group of products) according
to defined procedure. If a group of products describes the rational for choosing this grouping
strategy, then describe equipment, cleaning method & cleaning agents.

2.0 Purpose:

The purpose of this study is to demonstrate that remaining product residues of previous
product in a piece of equipment are always within the established acceptance criteria if the
equipment is cleaned by a defined cleaning method.

3.0 Scope :

 A visual test and a chemical evaluation of the equipment shall be performed after its
cleaning to demonstrate that product residue(s) (active ingredient, intermediates and / or
excipients) and cleaning agent residues (exclude solvents used in process) have been
removed to levels within the acceptance criteria.
 The equipment cleanliness shall be proven by testing and evaluation of samples in
accordance with this protocol from N# consecutive cleans. (N#: Generally, three consecutive
cleans are acceptable, however, companies must determine the number adequate for their
operation.)
 A report will be written assessing the data generated and thus determining the validity of
the cleaning process.
 The equipment must not be used to process another product until clearance indicating that
the equipment is adequately clean has been received from the validation department in
accordance with procedure.

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 Cleaning Validation Protocol
Company Name Company Logo
Document No. : CVP/ Product Code-XXX/NN *
Effective Date Revision No. :
4.0 Approval Signatures:

Following personnels are responsible for preparation, review and approval of Process
Performance Qualification Protocol.

Name/ Designation Signature Date

Prepared by

Name/ Designation Signature Date

Reviewed By

Name/ Designation Signature Date

Approved By

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 Cleaning Validation Protocol
Company Name Company Logo
Document No. : CVP/ Product Code-XXX/NN *
Effective Date Revision No. :

5.0 Responsibilities :

The responsibilities and functions are as tabulated below.

Team Responsibility
Manufacturing Dept. Responsible for Cleaning of Equipment

Quality Control Responsible for performing Testing of cleaning validation samples

Quality Assurance Responsible for review of data & approval of study

Validation Dept. Responsible for taking Validation samples
Engineering Dept. Responsible for review of data and approval of study

6.0 Sampling Procedure :

 Remove swab and rinse samples from the equipment as per the procedure. (Or if there is
no SOP in place describe the validated sampling technique for the QA / Validation
Dept. sampler).

6.1 Swab Samples:

 Swab samples should be removed according to swabbing procedure.

 The swab sampling locations are as follows:

 Product Residue Samples: list of sample locations and no. of swabs to be removed.
 Cleaning Agent Samples: list of sample locations and no. of swabs to be removed.

 Samples should be removed from the locations on the equipment deemed to be ‘worst
case’ i.e. most difficult to clean locations and therefore where product is most likely
to reside if cleaning has not been adequate. It is pertinent that these locations have
been determined scientifically and can be rationalised if necessary.

6.2 Rinse Samples:

 Rinse samples should be removed according to procedure.

 The volume of liquid used to rinse the equipment should be detailed in Protocol.
(Volume must be shown to be sufficient to cover all product contact surfaces of the
equipment).
 Samples should then be sent to the QC department for analysis. Any relevant
sample transfer conditions should be noted.

6.3 Microbiological Testing

 Microbiological test samples should be removed according to procedure (or if there is

no SOP in place describe the sampling technique for the QA /Validation sampler).

 The microbiological testing locations are as follows:

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 Cleaning Validation Protocol
Company Name Company Logo
Document No. : CVP/ Product Code-XXX/NN *
Effective Date Revision No. :

List of sample locations and no. of microbiological tests samples to be removed.

 Samples should then be sent to the QC department for analysis. Any relevant
sample transfer conditions should be noted.

7.0 Testing Procedure :

a. Rinse samples should be tested for:

 Product residues in accordance with analytical protocol
 Cleaning agent residues in accordance with analytical protocol

b. Swab samples should be tested for:

 Product residues in accordance with analytical protocol
 Cleaning agent residues in accordance with analytical protocol

c. Microbiological test samples should be tested for:

 Total Aerobic Microbial Count (TAMC)

 Note the limits of quantitation and detection as well as the % recovery for the tests
being performed.
 The analytical protocol should include a calculation to convert the amount of residue
detected in the sample to 100% (i.e. if the analytical validation results indicate that only
50% of spiked active / cleaning agent is recovered using the swabbing / rinse method of
choice, the amount of active cleaning agent recovered per sample should be multiplied
by 2 to bring result to 100%).
 All data generated should be attached to this study and returned to the Validation
department where calculations and adherence to acceptance criteria is
determined.

8.0 Acceptance Criteria :

 The Visual cleanliness of the equipment must be checked and verified after
cleaning according to the procedure.
 The swab / rinse sample acceptance criteria for product and cleaning agent residues
as well as the microbiological test acceptance criteria should be detailed along with a
rational for the figures quoted.

9.0 Deviations :

 Please indicate whether deviations occurred during the completion of this

Validation Protocol and give details especially with regard to impact on the
effectiveness of the cleaning validation and with regard to corrective and preventive
actions.

10.0 Revalidation:

 Define the Revalidation strategy for cleaning processes.

11.0 Abbreviations :

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 Cleaning Validation Protocol
Company Name Company Logo
Document No. : CVP/ Product Code-XXX/NN *
Effective Date Revision No. :

12.0 Annexures :

Sr. No. Annexure

1. Sampling Location Diagram (For Rinse, Swab & Microbial Swab)
2. Template for Recording Data

 Points To Consider:

 Surface area calculations should be performed, verified and kept on file for all
equipment evaluated.
 When the worst case result recorded is less than the limit of quantitation but greater
than the limit of detection for the test method, the value denoting the limit of
quantitation should be used to perform the calculations.
 When the worst case result recorded is less than the limit of detection for the test
being performed the value denoting the limit of detection should be used to perform
the calculations. Dirty Hold Times and Clean Hold Times.
 The period and when appropriate, conditions of storage of equipment before cleaning,
commonly referred to as The Dirty Hold Time (DHT) and the time between cleaning
and equipment reuse, prior to additional cleaning, commonly referred to as The Clean
Hold Time (CHT), should form part of the validation of cleaning procedures.
 This is to provide confidence that routine cleaning and storage of equipment does not
allow potential for build up of degradation products that may not be removed by the
standard cleaning procedure and does not allow potential for microbial contamination
of equipment and to ensure that these potential risks are properly assessed and
controlled.

* Where XXX stands for the sequential no. for Protocol

NN stands for revision no.

# Where F1 stands for Format No.

AA stands for Dept. Code
BB stands for SOP No.
NN stands for revision
no.

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