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CLEANING VALIDATION PROTOCOL

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EQUIPMENT

Serial number

Identification number
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CLEANING VALIDATION PROTOCOL

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CONTENT

Document history

Approval for performing of Cleaning Validation

General information about the Cleaning Validation

1. Scope of Cleaning Validation

1.1. Information about the equipment subject to cleaning validation
1.2. Description of the worst case product

2. Cleaning of the equipment

2.1. Procedure for cleaning
2.2. Cleaning and disinfection agents

3. Sampling plan and sampling procedures

4. Analytics
4.1. Analytical methods
4.2. Labeling and handling of samples
4.3. Limits of acceptance

5. Responsibilities od the Validation team

6. Appendices
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DOCUMENT HISTORY

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version
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APPROVAL FOR PERFORMING OF CLEANING VALIDATION

Equipment / Identification number:
Manufacturer:

Purpose of the Validation

The purpose of the Cleaning Validation is to provide documented evidence that the
established and approved cleaning procedure consistently provides the appropriate
chemical and microbiological cleanliness of the equipment according to the pre-
determined limits of acceptance.

The cleaning validation is used to determine:

- The maximum holding time between the end of production and start of
cleaning

- The maximum holding time after cleaning until the equipment is used again

APPROVED BY NAME AND POSITION DATE SIGNATURE

SURENAME
PRODUCTION
DEPARTMENT

QUALITY CONTROL
DEPARTMENT

QUALITY
ASSURANCE
DEPARTMENT

The Validation Protocol is prepared by:

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1. SCOPE OF VALIDATION
1.1. INFORMATION ABOUT THE EQUIPMENT SUBJECT TO CLEANING VALIDATION

Name / Manufacturer:
Identification number:
Location / Room nuber :
Total surface area which is in contanct with the product:
Short description:

1.2. WORST CASE DATA

Product name :
Active pharmaceutical ingredient (API):
Characteristics of the API:

Excipients :

The way of determination of this product as worst case is given in Appendix 6.2

The cleaning validation will be performed on three consecutive batches of this product.

2. CLEANING OF EQUIPMENT
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2.1. CLEANING PROCEDURE

2.2. CLEANING AND DISINFECTION AGENTS

Cleaning agent
Name :
Manufacturer:
Characteristics:

Disinfectant
Name:
Manufacturer:
Characteristics:

3. SAMPLING PLAN AND TESTING METHODS

The sampling plan and the testing methods are shown in the table below:
Type of test Sampling point Procedure Reference
Visual check

Test for residues of active

pharmaceutical ingredient
- swab sampling
Test for residues of active
pharmaceutical ingredient
- final rinse sampling
Test for residues of the
cleaning agent
Test for microbiological
comtamination - swab
sampling
Test for microbiological
comtamination - final
rinse sampling
The determination of the samling points of the equipment is shown in Appendix 6.4.
The analysis (clemical and microbiological) are performed in outsourced EU GMP certified laboratory

4. ANALYTICS
4.1. ANALYTIC METHODS
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The detection and quantitative determination of the residues of the product / cleaning agent are preformed
using validated analytical methods.
Subject of detection Analytical method Reference

Residues of the active pharmaceutical

ingredient (swab sampling)
Residues of the active pharmaceutical
ingredient (rinse sampling)
Residues of the cleaning agent

* pH and conductivity from the rinse sampling are determined, and using a comparative table from the
manufacturer of the cleaning agents, the quantity in ppm is determined.

4.2. LABELING AND HANDLING OF SAMPLES

- During the sampling, wearing of protective clothes including mask and gloves is obligatory
- Each sample is labeled with a number and the type of the equipment
- The samples for chemical analysis can be kept max. 24 hours after the sampling, in room temperature
- After the sampling, samples taken using swab sampling are dissolved in the appropriate solvent and
are treated according to the prescribed analytical method.
- The samples for microbiological analysis are kept in refrigerator, and are distributed max. 2 hours after
the sampling.
4.3. ACCEPTANCE LIMITS

The obtained results must be inside the following limits of acceptance

Type of test Acceptance limits

Visual check Visible residues from the product / cleaning agent

must not be found on the equipment surface
Residues of the active ingredient (swab sampling)

Residues of the active ingredient (final rinse sampling)

Residues of the cleaning agent

Microbiological contamination

The determination of the Acceptance limits is shown in Appendix 6.6.

5. RESPONSIBILITIES OF THE CLEANING VALIDATION TEAM

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The structure and responsibilitiees of the Team for cleaning validation is shown on the table below:

Activity Responsible person / Department

Cleaning of the equipment Operator / Production

Visual check Coordinator / Production

Sampling and chemical analysis Analyst / Quality Control

Sampling and microbiological analysis Analyst / Quality Control

Creation of list of products manufactured on the Reseacher / Research and developement
equipment with risk factor.
Evaluation of the risk factors and determination of the Cleaning validation team leader / Quality Assurance/
worst case product.
Creation of list of products manufactured on the Coordinator / Research and developement
equipment with batch size and maximum daily intake.

Determination of a next product worst case and Head / Quality control

determination of the acceptance limits.

Creation of Cleaning validation Protocol Cleaning validation team leader / Quality Assurance

Creation of Cleaning validation Report Cleaning validation team leader / Quality Assurance
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6. APPENDICES

6.1. List of products manufactured on the equipment with risk factors

6.2. Determination of worst case product

6.3. SOP for cleaning of the equipment

6.4. Determination of the sampling points on the equipment

6.5. List of products manufactured on the equipment with batch size and maximum daily intake

6.6. Determination of a next product worst case and determination of the acceptance limits