WATER SYSTEM VALIDATION PROTOCOL

VALIDATION PROTOCOL FOR PURIFIED WATER SYSTEM

 

(PHASE - I, II & III)

1.0	PROTOCOL APPROVAL SHEET:

Activity	Designation	Signature	Date
Prepared by	Officer – QA
Reviewed by	Executive – QA
Approved by	Manager -QA

 

2.0       TABLE OF CONTENTS

 

SERIAL NO.	ITEM DESCRIPTION	PAGE NO.
1.0	Protocol Approval Page	1
2.0	List of Content	2
3.0	Preamble	3
4.0	Objective	3
5.0	Scope	3
6.0	Responsibility	3
7.0	Purified Water System	4
7.1	Description Of Purified Water System	4
7.2	Schematic Diagram – Water System (Purified Water)	5
7.3	Details Of Equipment Used In Water System	5
8.0	Equipment Qualification	5
9.0	Validation Programme	5
10.0	List Of Points , Test And Frequency To Be Performed	6
11.0	Acceptance Criteria	7
12.0	Method of Testing	8
13.0	Disinfection And Sanitization	8
14.0	Deviation	8
15.0	Revalidation Criteria	8
16.0	Documentation , Reporting And Approval	8
17.0	Training	8

 3.0       PREAMBLE

Water plays in an important role in the pharmaceutical industry. It has both direct and indirect  applications  ranging  from  washing  of  equipment   to  actual  input  in  the manufacturing of products. Hence the quality of the water used is of utmost importance.

 Water validation is a establishing documented evidence, which Provides a high degree of assurance that the  process will consistently produce a product meeting its pre-determined  specifications and quality characteristics. Water validation is a requirement of the current Good Manufacturing Practices (cGMP)

             Regulations. To standardize the methods used in establishing water validation studies a  

water validation protocol is developed.

 4.0       OBJECTIVE:

            To lay down the guidelines of the validation programs of the purified

            water system   to qualify the system for its performance and to achieve a

            purified water consistently complying to the standards as per IP & In -House.

5.0       SCOPE:

This protocol is applicable to the validation of Purified Water system installed and operated at  -------------------------------

 6.0          RESPONSIBILITIES:

The validation group consist of Production Manager, Engineering Manager, and executive and above QC & Manager –QA. 

    Their specific responsibilities are as follows:

a.       Monitoring of protocol completeness, accuracy, technical excellence and applicability.

b.      Scheduling of validation runs.

c.       Conducting of validation runs.

d.      Data review and validation run acceptance.

e.       Validation reports preparation.

 

Sampling and Testing of PW and reporting of results shall be done by Quality Control. Production department shall be responsible for Provide an operator and Supervisory personnel

 7.0              PURIFIED WATER SYSTEM :

Purified Water is produced from Raw Water   as per the requirement. It shall conform to the test of Purified Water.

7.1          DESCRIPTION OF PURIFIED WATER SYSTEM:

                The Purified Water System consists of:

1.                  Raw water storage tank

2.                  Chlorine dosing system

3.                  Multi Grade Sand Filter

4.                  SMBS Dosing system

5.                  Activated Carbon Filter

6.                  Micron Cartridge Filter (MCF)

7.                  High Pressure pump

8.                  Reverse Osmosis Purifier  (RO-I)

9.                  RO-I Water Storage Tank

10.              UV-I

11.              Reverse Osmosis Purifier  (RO-II)

12.              Purified Water Storage tank

13.              UV-II

14.              User Outlets

Raw Water treated with chlorine dosing and then passes through Multi Grade Filter (MGF) which treats with SMBS Dosing system and water passes through the Activated Carbon Filter (ACF) after that treated water passes through to softener and after that treated with Antiscalent dosing system.

  

The Purified Water produced meets the requirements of IP and In-House specifications.

The Purified Water is distributed to Production Department. Purified water is circulated at a velocity of more than one meter/sec. The required pressure of 1 bar is maintained in the return loop and designed flow rate of water is 1.6 Meter/Sec.

 

The Distribution Lines are made of SS-316 L, electro polished and Argon welded. Required slope of 1” per 100 meter is maintained to get complete drainage at any point. Temperature of Purified Water is consistently maintained at ambient temperature throughout the distribution System & in Storage Tank.

 

The Water System Validation is performed as per the Approved Protocol. The Protocol shall cover the validation of water quality.

 

 

7.2          SCHEMATIC DIAGRAM – WATER SYSTEM (PURIFIED WATER)

 

               Attachment - A

 

7.3          DETAILS OF EQUIPMENT USED IN WATER SYSTEM:

 

               Attachment-B

 

 

8.0                    EQUIPMENT QUALIFICATION :

 Design , Installation and Operational Qualification of the purified water system and the online ancillary equipment and instruments will be carried out as per the respective protocols and the performance qualification of the system will be carried out along with the validation of water system.

 

 9.0          VALIDATION PROGRAME:

 

Validation of water system will be carried out over three phases.

 

PHASE-I :

This phase of validation will be carried out for a period of 30 days identifying all the critical points to be sampled and tested daily for chemical attributes as well as microbiological analysis.

 PHASE –II :

This phase of validation will be carried out for a period of 30 days identifying all the critical points to be sampled.

The frequency of testing will be reduced based on data available from phase-I.

PHASE –III :

This phase of validation will be carried out for a period of year, identifying all the Critical points to be sampled.

The frequency of testing will be reduced based on data available from phase-I and                       

Phase-II. This shall be decided after completions of phase I and Phase II.

10.0 LIST OF POINTS, TEST AND FREQUENCY TO BE PERFORMED:

  

Test:

Chemical analysis

Microbiological analysis.

                                               

Note: Parameters under chemical and microbiological analysis are specified in the

Respective specification.                               

Location	Frequency for Phase-I	Frequency for Phase-II	Frequency for Phase III
Raw Water (Borwell water )	Daily	To be decided based on data available from Phase I	To be decided based on data available from Phase I & II

 

 

Sr. No.	Location	I.D. NO.	Frequency for Phase-I	Frequency for Phase-II	Frequency for Phase III
1	PW Plant	RWSP/01	Daily	Daily	To be decided based on data available from Phase I & II
2	PW Plant	RWSP/02	Daily	Daily
3	PW Return Loop	RWSP/03	Daily	Daily
4	Ointment Washing	RWSP/04	Daily	Daily
5	Oint. Manufacturing 1000L	RWSP/05	Daily	Daily
6	Oint. Manufacturing 1000L	RWSP/06	Daily	Daily
7	Oint. Manufacturing 1000L Washing	RWSP/07	Daily	Daily
8	Ointment Manufacturing 500L	RWSP/08	Daily	Daily
9	Solution Preparation Room	RWSP/09	Daily	Daily
10	Coating	RWSP/10	Daily	Daily
11	Granulation-I	RWSP/11	Daily	Daily
12	Granulation-I	RWSP/12	Daily	Daily
13	Granulation-I Paste Room	RWSP/13	Daily	Daily
14	Granulation-II	RWSP/14	Daily	Daily
15	Granulation-II Paste Room	RWSP/15	Daily	Daily
16	Compression Washing	RWSP/16	Daily	Daily
17	Capsule washing	RWSP/17	Daily	Daily
18	Quality Control	RWSP/18	Daily	Daily

 

 

 

11.0        ACCEPTANCE CRITERIA:

The Validation shall be considered acceptable when results of analysis of water samples from all sampling points meets the pre-determined specifications of purified water.

 

               Microbiological test:

                                                           

               Total Microbial Count: -      Alert Limit      : 50 CFU / ml

                                                            Action Limit   : 100 CFU /ml

 

               Pathogen                  : Absent / 100 ml

 

  12.0     METHOD OF TESTING:

Copies of respective specification containing the method of testing of each parameter identified under acceptance criteria will be attached in the validation report. 

 13.0          DISINFECTION AND SANITIZATION :

The frequency and the rate of dosing shall be fixed based on the actual observations during the validation.

 

14.0     DEVIATION:

Any deviation from SOPs and Protocols in Phase I and Phase II will be documented

Authorised and corrected in subsequent phases of validation.  

  15.0       RE- VALIDATION CRITERIA :

Any modification , addition or deletion of equipment or change in make of the equipment or relocation of the purified water system or part of the system will call for revalidation of the purified water system.

 

16.0        DOCUMENTATION , REPORTING AND APPROVAL :

The data obtained will be complied, reviewed and documented as a Validation summery report. It will be prepared and reviewed by QA department and will be approved by manager QA.

 

17.0        TRAINING

A detail training programs with a schedule will be given by Manager QA., to train the Maintenance, Production QC & QA.