QualityGuidances

1.0) OBJECTIVE:

To describe a procedure for Qualification of Water Treatment Plant.

2.0) SCOPE:

This SOP is applicable for Qualification of Water Treatment Plant

3.0)  RESPONSIBILITY:

      Assistant Engineer/Above shall be responsible for implementation and compliance of the SOP.

4.0) ACCOUNTABILITY:

Manager-Engineering / Manager-Production / Head-QA shall be accountable for implementation and compliance the procedure mentioned in this SOP.

5.0) ATTACHMENT:

Checklist for Qualification of Water Treatment Plant                                          – Attachment -I

6.0) PROCEDURE:

6.1       DESIGN QUALIFICATION:

6.1.1   During the concept study, based on the guidelines and discussion with team of Engineering &

Production department, calculate the requirement of purified water per day consumption in liters &

peak demand of purified water in Liters / hour.

6.1.2   QC should provide control procedures, which include specifications of Raw water, Soft water,

Purified water and method of analysis for purified water.

6.1.3    Collect the information regarding location of each user point for purified water. Identify these points

& number them. Depending upon the daily requirement, finalize the capacity of storage tank.

6.1.4    Prepare detailed URS attaching copy of all above document including the information as per points

6.1.1 to 6.1.3 with input from QA and projects.

6.1.5    Send the URS for approval of Head of Use department and Head-QA.

6.1.6    Hand over the controlled copy of the URS to Engineering.

6.1.7    Engineering to send the URS copies (Uncontrolled copy) to the consultant.

6.1.8    Based on URS, the consultant to prepare tender document in discussions with Sano Cito

Therapeutic Inc. The  tender document should have minimum following technical information:

• Preferred filtration mechanism.
• Preferred treatment mechanism.
• Material of construction (System, filters, gaskets etc)
• Alarms & indicators required.
• Controls required, instrument required.
• PLC operations & minimum parameters to be set from PLC

6.1.9   Select the vendors and issue tender document. The issue of tender to be done jointly by consultant and preferably discussing the technical and documentation requirement aspect of tender.

6.1.10   Consultant to receive the reply for tender and evaluate the same technically. Consultant to highlight

deviations, shortcoming, alternatives and corrections suggested by vendor clearly in his technical

evaluation.

6.1.11   Carryout the bid evaluation of techno-commercial offers and select the vendor by placing the LOI & or order

6.1.12  Conduct joint discussion with vendor, Sano Cito Therapeutic Inc. and / or consultant for detailed Engineering.

After these discussion, vendor to submit minimum following details and drawings.

• Final review of P & ID.
• Plant layout with necessary co-ordinates
• Final agreed detailed fabrication drawing for Purified water tank.
• Electrical & control circuit diagram.
• All interlocks, safety precautions, if any
• Details of treatment process with respect to P & ID.
• Sanitization & reference to P & ID
• Data sheet of all bought out items
• List of all operating parameters with their Maximum & Minimum limits.
• Copy of all drawing, documents, details to be submitted prior to award of contract.

6.1.13   Sano-Cito and / or consultant to study these documents & should comment. In case of any  revision is suggested the vendor should submit the revised documents.

6.1.14   The documents generated from 6.1.2 to 6.1.13 & related documents from vendor’s end will be compiled as  DQ document, Attachment – I.

6.2      INSTALLATION QUALIFICATION:

6.2.1   Inspection at manufacturer’s site by Sano Cito Therapeutic Inc. / consultant / third party inspector as deemed necessary for the confirmation of:

• Boroscopic of welded joints wherever required (Minimum 10% of total welded joints).
• Dimensional checks of fabricated items.
• Checking & reporting of entire skid for dimensions, References to P & ID, Labeling, other engineering points.
• Verification of bought out items against the data sheets submitted during design.

6.2.2    Verification on receipt at site involves

• Receipt of material at site.
• Cross verification of received material for its specifications against specifications approved during Design Qualification.
• Prepare verification note (Vendor can use his standard format or can evolve format in discussion with Sano-Cito).
• Any deviations to be noted.
• Approval of final verification note by consultant and Sano-Cito or either of them.

6.2.3    Verification of installation.

The installation can start progressively as the receipt of material on site progresses. The activity of

verification of received material at site will continue simultaneously till the entire material is received.

• Checking of installation to be carried out with respect to details, drawings approved during Design Qualification step.
• Prepare Installation check sheets to ensure the installation checks for general engineering items like installations of gaskets between flanges, tightening of bolts etc. These checks sheets should be marked clearly to identify the number of checks.
• Similar exercise to be carried out to check the electrical installations simultaneously. The drawings, details approved during Design Qualification stage should be used. The check for general electrical checks to be carried out. This exercise can be combined together with the installation checks described in point 6.2 above.

6.2.4   Based on the above information assess the correctness of the installation and record observations in

the Attachment-II “Check list for Installation Qualification”

6.2.5    Compilation of all documents as stated above from step 6.2.1 to 6.2.4 including all MOC certificates,

calibration certificates / verification reports with IQ summary sheet forms the IQ.

6.3     OPERATIONAL QUALIFICATION: 

6.3.1   By referring the operation manuals / operating procedure in consultation with the vendor, prepare the

draft standard operational procedures for the operation of PW system (Including cleaning, Sanitization

and Regeneration..

6.3.2   Ensure on the job training for operator is imparted preferably by vendor.

6.3.3   Ensure the measuring devices e.g: gauges, dials, indicators, sensors, transmitters are calibrated before Operation Qualification exercise.

6.3.4   Ensure that all utilities are operating satisfactorily. Engineering to ensure for availability of utility.

6.3.5   Evaluate the critical operational parameters to be checked. 

6.3.6   Based on the draft operational procedures & critical operational parameters prepare the OQ protocol.

6.3.7   Assess the critical parameters in consultation with vendor. The protocol should specify acceptance

criteria based on the functional specifications and / or design specifications, which should demonstrate the PW plant related systems or sub-system operate as specified & all interlocks working satisfactorily as per design.

6.3.8   Carry out the OQ exercise as per protocol in presence of vendor.

6.3.9   If the PW system meets the acceptance criteria, prepare the OQ report and finalize the operational

SOPs (Including Cleaning, Sanitization and Regeneration). Attach any raw data generated during the operation.

6.3.10  In case the acceptance criteria are not met, record & report the deviation.

6.3.11  Analyze the deviation to assess whether the deviation occurred due to malfunctioning of the

equipment /  utilities or errors in operation by operators or errors in the operation SOP.

6.3.12  In case of errors in operational SOP, edit the SOP and repeat the OQ exercise starting from point  6.3.6.

6.3.13  In case of equipment malfunctioning vendor to take corrective action & offer equipment for operating  trail.

6.3.14   Repeat the OQ exercise starting from point 6.3.6.

6.3.15  In case of malfunctioning of utilities, Engineering to take corrective action & offer equipment for

operating trail. In case of errors in operation retrain the operators.

6.3.16  Repeat the OQ exercise starting from point no. 6.3.6.

6.3.17  Operation & Performance qualification can be combined to have protocol / report.

6.4      PERFORMANCE QUALIFICATION: 

6.4.1    Ensure the following prerequisites are completed.

• Specifications for input water, water at intermediate phase of system if any and PW
• Analytical methods respective to the specified quality parameters
• The required instruments are in qualified / calibrated state.
• SOP for drawing water samples
• PW plant should be in the ready state with respect to Cleaning, Sanitization and Regeneration before start of PQ and the frequencies of the same to be maintained during PQ exercise.

6.4.2    A protocol should be defined to carry out the PQ in three phases Phase-I, Phase-II and Phase-III. P &

ID showing the system components & the sampling points should be with the protocol. Protocol

should specify:

• Sampling points
• Sampling frequencies
• Tests to be performed and the acceptance criteria

6.4.3   While defining the sampling points, the criteria as specified further for individual PQ phases and DQ

documents (P & ID) should be considered.

6.5      PHASE-I:

6.5.1   Phase-I should continue for 2 weeks. During Phase-I purified water produced should not be used for

any manufacturing activities. Quantity produced should be representative quantity of the daily

requirement. Phase-I serves the basis for the verification of operating procedures / parameters. The

minimum sampling and testing criteria should be as mentioned in Table-1.

• Table-1

 

Stage	Physical and Chemical tests	Microbiological and Biological tests
Phase-I	– Each sampling point should be sampled after every second day.	– Each sampling point should be sampled after   everу alternative day. –  Last sampling point of Loop recirculation Daily.

6.6     Phase-II:

 6.6.1 This second phase of PQ should start only after successful completion of Phase-I and results are

summarized. This phase should continue for 2 weeks. During Phase-II purified water produced

should be used for the manufacturing activities. The release decision on the batches produced during

Phase-II  phase should be taken after assessing the Phase-II data. The minimum sampling and testing

criteria should be as mentioned in Table-2

• Table-2

 

Stage	Physical and Chemical tests	Microbiological and Biological tests
Phase-II	– Each sampling point should be sampled after every second day.	– Each sampling point should be sampled after   everу alternative day.

6.7     Phase-III :

 6.7.1  Phase-III should continue for about 11 months (48 weeks) to ensure that the PW produced by the

plant is consistently meeting the specified performance criteria regardless of any seasonal influences.

The minimum sampling and testing criteria should be as mentioned in Table-3. Based on the results of

Phase-I and Phase-II, any additional sampling point testing should be considered.

• Table-3

 

Stage	Physical and Chemical tests	Microbiological and Biological tests
Phase-III	– The storage tank and last sampling point in   Loop recirculation at least once in a weak.	– The storage tank and last sampling point in Loop recirculation at least once in a weak.

6.7.2  If the PW system meets the acceptance criteria as per the protocol, prepare the respective PQ report

(interim report for Phase-I and Phase-II and final edition after Phase-III phase should be prepared).

Attach any raw data generated during the qualification exercise to PQ report.

6.7.3  Any out of specification reported should be investigated through the formal procedure.

6.7.4  Operational breakdowns and / or deviations should be assessed for the impact on the Qualification

Exercise based on the impact assessment decision should be taken for further qualification program.

6.8    REVALIDATION CRITERIA: 

6.8.1 Periodic revalidation: 

• After every three years the performance of the PW system to be assessed by User, Engineering and QA department for GMP compliance. Any deviation addressed during this period should be evaluated. Depending upon the evaluation the need and the scope of periodic revalidation should be determined.

6.8.2 Revalidation in event of change:

• In case of changes to PW system, e.g:-
• Change in quality of feed water
• Any changes made to system design and components
• Modification or addition of sampling point
• Change in the water quality relevant specifications
• Modifications & / or addition of storage water tank & distribution loop

6.9    All critical equipment and systems procured after effective date of this SOP should be qualified as per

the procedure given in this SOP.

• REFERENCES:

 In-House.

8.0 ABBREVIATIONS:

SOP: Standard operating procedure

QA: Quality Assurance

QC: Quality Control

PW: Purified water

URS: User requirements specification

DQ: Design qualification

IQ: Installation qualification

OQ: Operational qualification

PQ: Performance qualification

GMP: Good Manufacturing Practice

PLC: Programmable Logical Controller

MOC: Material of construction

P&ID: Piping and instrumentation diagrams

9.0       DISTRIBUTUON LIST:

Engineering

Quality Assurance

Quality Control

Production

10.0     HISTORY OF REVISION:

Version No.	Effective Date	Reason for Revision

Attachment-I

Design qualification Summary sheet

 

Name of client	Type of submittal	Date	Submitted by
Sano-Cito	Summary sheet of Design Qualification for Purified water system

Description of Equipment           : PW generation, storage & Distribution system

 

System Identification number            :

 

Scope covered by system        :

Reference document                    : Give list of all reference documents & documents attached

 

Sr. No	Description of item /		Acceptance criteria based on URS & Tender document /		Design submitted by
1	Type of water to be generated by system		Purified water meeting as per-IP,BP&USP pharmacopoeia and Local norms
2	Limiting parameters for PW		Conductivity: ≤ 1..3 µs/cm at 25°C Microbial counts / NMT 100 cfu/ml E.Coli, Salmonella, P. Aeroginosa, S. Aureus must be absent
3	Flow rate for generation		Approximately 270 Liters / Hour
4	Number of user points	18
5	Loop temperature	Ambient temperature
6	System sanitization method	Preferred: Hot water Sanitization at NLT 80°C.
7	MOC after final treatment	SS316 L EP / Fully fluorinated polymer with standing sanitization temperature
8	MOC for Gaskets / Diagraph	Silicone / EPDM / PTFE
9	Minimum velocity in return line of loop	Not less than 1 M/Sec.
10	MOC of loop / Storage tank	SS316 L EP / Fully fluorinated polymer withstanding sanitization temperature
11	Loop sanitization method	Preferred: Hot water sanitization at NLT 70°C.
12	Storage tank vent	Through micron sanitary filter with heating element
13	MOC of vent filter	Hydrophobic, withstanding sanitization temperature.
14	Slope to be maintained in Loop	1:50
15	Preferred PW generating methods	UF / RO / DM – Combination of these all or any two

Attachment-II

Installation qualification checklist

 

Name of client	Type of submittal	Date	Submitted by
Sano-Cito	Checklist for Installation Qualification for Purified water system

 Description of Equipment        : PW generation, storage & Distribution system

System Identification number  :

Scope covered by system        :

Reference document                : (Give list of all reference documents & documents attached)