1.

0 Objective:
This document OQ001-17 intends to provide documented evidence that the newly installed Reverse
Osmosis Water Purification System is capable to consistently produce purified water that meet the pre-
defined requirement throughout all anticipated operating ranges.

2.0 Scope:
This protocol is applicable to Reverse Osmosis water purification system located at Purified Water
Room #2 of XX Company.

3.0 Background:
XX Company is currently utilizing Deionized Water System to generate purified water for cosmetic
products preparation. The new system is anticipated to produce Purified Water specification as per
European Pharmacopoeia guidelines and adhering to the Malaysia Cosmetic GMP Guideline. Below Table
1 described the specification comparison between current purified water system and required RO water
specification.

Parameter CURRENT SYSTEM: NEW SYSTEM:

Deionized Water System Reverse Osmosis System
(NCCLS (1998), TYPE III) (European Pharmacopoeia)
Conductivity  10 µS/cm at 25°C < 5.1 µS/cm at 25°C
Bacteria Count  100cfu/ml  100cfu/ml
Coliform Absent Absent
TOC (optional) N/A < 0.5 mg/l
pH 5-8 5–7
Heavy metal NA  1.0ppm
Total Dissolved <7.5mg/L N/A
Solid

3.1 System Design Details

The water system design has the following major stages of pretreatment, purification,
distribution and control.
3.1.1 Pre-treatment stage: Multimedia Filtration, Carbon Filtration and Production of
Soft Water.
3.1.2 Purification stage: generation of reverse-osmosis water
3.1.3 Storage and Distribution System for normal and hot purified water
3.1.4 Control Panel for generation and distribution system for normal and hot purified
water.

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4.0 Operational Qualification (OQ) Protocols
Validation activity shall be carried out by filling the required data into the Operational Qualification
Checklist.

4.1 Test Program

The Operational Qualification of water system shall be carried out in four phases:
(a) Phase 1 - sampling for 4 weeks (01.11.2017 – 30.11.2017)
(b) Phase 2 - sampling for 4 weeks (01.12.2017 - 31.12.2017)
(c) Phase 3 - sampling for 12 weeks (01.01.2018 – 30.04.2018)
(d) Phase 4 - sampling for 6 months (01.05.2018 – 30.11.2018)

During the 4 phases of operational qualification activities, all maintenance record shall be
documented. Any deficiency in the systems equipment shall be investigated and rectify. The
result data of purified water system shall be tabulated periodically and the data summary shall
be reviewed.

The detailed methodology of the 4 phases of validation is as stated below:

4.1.1 Phase 1: For a period of 4 weeks

The operational qualification of water system shall be started when all the equipment and piping
of water system have been verified to be installed properly and are operating correctly.

Phase 1 of the operational qualification of water system shall include sampling of water, from all
usage points for a period of 8 weeks. Sampling and testing of water for microbiological analysis
shall be carried out as per stated on the Testing Method W(QA)6.3.1.6(45) and W(QA)
6.3.1.6(57). During this phase water samples from the usage points shall be analyzed and
monitored for compliance to the predetermined specifications. During this phase, the purified
water is not allowed to be used in bulk product preparation except for all cleaning activity.

Once the purified water is comply to the predefine specification, QC department shall advice
Research and Development department to initiate laboratory trial of bulk product preparation
based water based on product types i.e shampoo, shower cream, lotion and etc. The product
stability record shall be documented accordingly.

At the end of four-week time period, the standard operation procedure of the water system shall
be developed.

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4.1.2 Phase 2: For period of 4 week

Phase-2 of the operational qualification shall commence, after successful completion of Phase-
1. The second phase of the system validation will demonstrate that the system will consistently
produce the desired water quality when operated in conformance with the SOPs. The sampling
is performed as in the initial stage and for the same time period.

During this phase, the purified water is not allowed to be used in bulk product preparation except
for all cleaning activity and laboratory trial.

After successful completion of Phase-2 of the operational qualification, the data should
demonstrate that the system will consistently produce the desired quality of water.

4.1.3 Phase 3: For a period of 4 months

Phase 3 of the operational qualification shall commence, after successful completion of Phase-
2. The objective of Phase-3 is to demonstrate that when the water system is operated in
accordance with the SOP over a long period of time it will consistently produce water of the
desired quality. Any variation in the quality of the feedwater that could affect the operation and
ultimately the water quality will be picked up during this phase of validation. Sampling is to be
performed according to the routine procedures and frequencies. The validation of water systems
will be completed within full year worth of data.

After four weeks of this phase, if the system is capable to deliver chemical and microbiological
controlled-purified water, provided that the products types showed stability under laboratory
trial, the water will be allowed to be used for bulk product preparation.

After completion of Phase 3, Alert and Action limits of testing parameters will be calculated as
per given equation and these alert and action limits will be followed for further qualification of
water system.

Alert levels are levels or range that, when exceeded; indicate that a process may have drifted
from its normal operating condition. Alert levels constitute a warning and do not necessarily
require a corrective action.

Alert Level = (Average + 2) x Standard Deviation

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 Action levels are levels or range that, when exceeded, indicate that a process has drifted from
its normal operating range. Exceeding an Action level indicates that corrective action should be
taken to bring the process back into its normal operating range).

Action Level = (Average + 3) x Standard Deviation

For parameters that the alert and action level not suitable to be calculated based on the above
formula, recommended alert and action level from certified regulatory body will be used.

4.1.4 Phase 4: For a period of 6 months

Phase 4 shall commence immediately after completion of Phase 3. When the third phase is
completed data shall be collected and routine monitoring schedule shall be frozen. Samples shall
be collected from selected sampling points once a week and shall randomly cover all user points
in a week.

The objective of Phase 4 is to demonstrate that the water system is capable of producing
predetermine specification quality of water, by taking care of all possible seasonal variations,
when operated in accordance with the established SOP’s over a long period of time. The sampling
shall be done as per the routine sampling procedures.

5.0 References

5.1 FDA’s Office of Regulatory Affair: Guide to Inspection of High Purity Water System.
5.2 DQ001-2016 Design Qualification for RO Water Purification System.

6.0 Acceptance Criteria

Operational qualification shall be considered acceptable when the specification listed in below
table are met and all the components of purified water generation, storage and distribution
system are performed as per design specification and as per manufacturer recommendation.

Parameter Specification
Conductivity < 5.1 µS/cm at 25°C
Bacteria Count  100cfu/ml
pH 5–7
Total Dissolved Solid < 50ppm

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 Distribution flow rate (FM05) > 6.0 m3/hour
Feed water hardness (mg/L) < 20 ppm
Coliform Absence

7.0 Responsibility

7.1 Quality Assurance Department

7.1.1 To prepare protocol and record.
7.1.2 To review protocol and record.
7.1.3 To execute related data collection.
7.1.4 To interpret operational qualification data.
7.1.5 To prepare Operational Qualification report.

7.2 Maintenance Department

7.2.1 To review protocol and record.
7.2.2 To execute related Operational Qualification as per protocol.
7.2.3 To execute related data collection

7.3 Management
7.3.1 To review Operational Qualification protocol and report.
7.3.2 To approved execution of Operational Qualification protocol.
7.3.3 To approved Operational Qualification Report.

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