Equipment cleaning validation program

PROCEDURES / INSTRUCTIONS

equipment cleaning validation program

Equipments Cleaning Qualification Protocol

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1. the Description

Manufacturing Equipment's for Dermasil OTC skincare product includes vacuum emulsification mix tank group & Liquid Automatic Filling Machine. These equipments adopt stainless steel materials, and facilitate cleaning and resist disinfection. They are easy to control and have good design, flexible and stable system, sensitive temperature adjusting. These Skin are Used to Produce Equipments Care Products's Same, with the Active Ingredients. Control at The Microorganism IS Significant.

2.Purpose

OTC

This is to check and verify if these equipments for OTC products are scientific and designed to facilitate operation.

3.cope

3.1. Dermasil OTC

This protocol is applied for cleaning qualification of these equipments for Demersil OTC Skincare

4. Role & Responsibilities 4.1. QA manager

4.1.1.

Assign team leader, approve validation protocol and reports, issue validation certificate and decide re-validation frequency.

4.2. Team leader

4.2.1.

Team leader is the leader of specific qualification projects, lead to and coordinate qualification assignment, draft the protocol and collect the data and records and sort out reports. 4.2.2.

Draft first cleaning validation protocol and complete the reports, and guide the implementation, training and technical transfer of the qualification.

4.3. QA

4.3.1.Review of qualification data and results. 4.3.2.

Supervise the qualification and review validation report. 4.3.3.。Manage qualification documents.

4.3.4.



Develop validation plan and supervise the implementation of validation and manage the documents.

4.4. LAB

4.4.1.

Develop inspection methods and limits of residue (products left, microorganism, cleaning agent). 4.4.2. 。Establish sampling methods

and sample for tests, and evaluate the qualification results.

4.4.3. Guide the production department to

choose cleaning agent and cleaning methods.

4.5. Production

4.5.1. Make the

procedure for cleaning and conduct cleaning activities and do training for the operators.

4.5.2. 。Arrange personnel and adjust time, and

provide necessary resources.

4.6. Maintenance

4.6.1. Do training of de-assembly and

installation.

5.

Qualifications

5.1. 。Follow the procedure to clean the equipments after

production.

5.4.
Physical inspection: use sterile blue or color different from that of the product cloth with 75% ethanol to wipe their surfaces, no residue is visible。

5.5. Residue

concentration limits: active ingredients used include dimethicone, they are highly safe raw materials without toxin. So we use physical check after cleaning is accepted. And if necessary we will send once to 3rd party for checking residue.

5.6. Microorganism examination

5.6.1. WI-006&WI-008。

Vacuum emulsification mix tank group & Liquid Automatic Filling Machine use washing water to clean. After clean the tank and homo-mixer, we use purified water to wash the homo-mixer. Samplings refer to WI-006, and sent to micro lab. Micro test method refers to WI-006&WI-008.

5.7.Re-qualification frequency

QAQA to decide the re-qualification frequency after verifying the results. 6.

Deviation Handling



Any deviation found will follow Deviation control procedure for handling and investigation. 7.

Reference

7.1.  WI-011 7.2.WI-006 7.3.WI-008 7.4. WI-001 8.

Attachment

8.1.Equipments Cleaning Qualification Records

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