FAC-32 Rev.

Mar 1 2018

CODE:
TITLE: VALIDATION PROTOCOL

Created by: Position: Signature: Creation date:

Revised by: Position: Signature: Revision:

Authorized by: Position: Signature: Revision date:

Authorized by (client): Position: Signature: Revision date:

VALIDATION PROTOCOL

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1.0. Purpose.

1.1.

2.0. Scope.

2.1.

3.0. Roles and Responsibilities

3.1. Microbiology analyst.

3.2. Quality manager.

3.3. Quality Head.

4.0. Definitions

5.0. Materials.

5.1. Culture media.

5.2. Solutions

5.3. Reagents

5.4. Materials and instruments

5.5. Control microorganisms.

5.6. Test matrices

Product/Matrix Dilution used

6.0. Equipment.

7.0. Solutions preparation.

7.1. Stock solution

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7.2. Working solution (working buffer solution)

7.3. Culture Media

8.0. Procedure.

8.1. Suitability test of the method

8.1.1. Preparation of reference microorganisms

8.1.2. Preparation of suspensions for count/determination of specific microorganisms

8.1.3. Sample preparation

8.1.4. Inoculation and dilution

8.1.5. Microorganism count/presence.

Acceptance criterion

9.0. Expression of results

Report as appropriate for the test performed on the sample as follows:

10.0. Quality Assurance

10.1. Quality Controls

11.0. Acceptance and rejection criteria

12.0. References.

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13.0. Change Control

Review No. Sheet Responsible Change

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14.0. Flowchart