设备确认操作规程(英文)

PURPOSE:

To provide a formal methodology to be followed during qualification of equipment.

SCOPE:

Applicable to qualification of new equipment, re-qualification of equipment, which has undergone major modification, relocation of equipment and Periodic Qualification as per schedule in Pharma manufacturing department.

RESPONSIBILITY:

Production, Engineering, Safety, Quality Control and Quality Assurance staff. DEFINITION:

Qualification: Documented verification that the environment and equipment are appropriate for the designated function.

User Requirement Specification (URS): A Requirement specification that describes what the equipment or system is suppose to do, thus containing at least set of criteria

or conditions that have to be met.

Functional Design Specification (FDS): Functional design specification is a document that specifies in a complete, precise, variable manner, the requirement design, behaviour or other characteristics of a system or component and often the procedures for determining whether these provisions have been satisfied.

Specification that is offered by manufacturing based on URS and are agreed mutually. Design Qualification (DQ): Formal and systematic verification that the requirements defined in the specification phase are completely covered by the succeeding specification or implementation phase.

Factory Acceptance Test (FAT): Testing conducted at the suppliers factory to determine whether or not a system specifies it?s acceptance criteria and to enable the user to determine whether or not to accept the system.

Installation Qualification (IQ): Documented verification that a system is installed according to written and pre-approved specifications.

Site Acceptance Test (SAT): An acceptance test at the users site, usually involve the supplier.

Operation Qualification (OQ): Documented verification that a system operates according to written and pre-approved specification throughout all specified operating ranges.

PLC Validation: Documented verification that PLC Hardware are as per original drawing, Digital and Analog Input and Output are connected as per PLC Architecture and functioning according to written and pre-approved specification throughout all specified operating ranges.

Performance Qualification (PQ): Documented verification that a system is capable of performing or controlling the activities of the processes, it is required to perform or control, according to written and pre-approved specifications, while operating in its specified operating environment.

User (s): The person, or persons, who operate or interact directly with the system. Supplier: Any organisation or individual contacted directly by the user to supply a product or service.

Critical Equipment: The machine within a system where the malfunctioning or failure of equipment will have direct impact on product quality. Where product is in direct contact with machine body parts.

Non-critical Equipment: The machine within a system where the malfunctioning or failure of equipment will not have direct impact on product quality. Where product is not in direct contact with machine body parts.

1.0 HEALTH, SAFETY AND ENVIRONMENT: (对验证实施人员的HES要求)

1.1 Personnel involved in qualification / re-qualification / periodic qualification

should use appropriate personal protective equipment.

1.2 Do not touch the moving parts.

1.3 Electrical isolation should be done before any electric control panel

verification.

1.4 Read the safety instructions specified in the operation Manual of the

machine to be qualified.

2.0 PROCEDURE:

2.1 Equipment qualification should be based on the following documents

2.1.1 User Requirement Specification (URS)

2.1.2 Functional Design Specification (FDS)

2.1.3 Design Qualification (DQ)

2.1.4 Factory Acceptance Test (FAT)

2.1.5 Checklist on Receipt

2.1.6 Installation Qualification (IQ)

2.1.7 Operation Qualification (OQ)

2.1.8 PLC Validation ( If applicable)

2.1.9 Provisional Handover Certificate

2.1.10 Performance Qualification (PQ)

2.1.11 Handover Certificate

The flow of the equipment qualification is as follows

URS → FDS → DQ → FAT → IQ → OQ → PLC Validation (if applicable)

SAT→ PQ

2.1.1 User Requirement Specification (URS):

2.1.1.1 URS protocol should be approved by the project team

(Users) members and Quality Assurance with Name, Sign

and Date.

2.1.1.2 Following points should be considered during the

development of URS.

Introduction

Over view

Operation requirements

Constraints

Life cycle Glossary References Approval

2.1.1.3 Each URS protocol should be allotted with a protocol no. in

the format specified below “URS/P”

Where,

“URS” stands for User requirement specification.

“P” stands for equipment / instrument / balance / area abbreviated code.

2.1.1.4 The protocol should also identify with a Version No. Where

the version no. changes with every change in the URS.

2.1.1.5 The URS protocol header should consist of the following details

as mentioned below:

Title of the URS

Protocol No. Version No. Date

Cipla Patalganga Unit

Page No.

A specimen of the header is given below:

2.1.2 Functional Design Specification (FDS):

2.1.2.1

The FDS should be the manufacturer interpretation of URS. FDS should include basic functioning of the equipment with focus on control and critical components specifications and functions.

2.1.2.2 The FDS should be in the form of separate document

and should include equipment specification, P&ID

diagrams.

2.1.2.3 The FDS protocol / report should be mutually approved

by the user and supplier with sufficient technical details

based on the techno commercial offer.

2.1.2.4 The supplier is finally selected and CER is raised.

2.1.2.5 Any changes made after finalisation of DQ should under

go change control procedure as per SOP CQA 06.

2.1.3 Design Qualification (DQ):

2.1.

3.1 Design qualification should be based on the discussion

between the supplier and the user with reference to

URS / FDS.

2.1.

3.2 Following points should be considered during the

development of design qualification.

Purpose

Scope

Responsibility

Project requirement

Critical variables to be met

Process/ Product parameters e.g. Capacity etc.

cGMP considerations

e.g. MOC of individual parts, finish of contact parts

Critical parameters e.g. Instrumentation, limits,

Safety

Location suitability

References

Documents to be attached.

Any changes made against the formally agreed

parameters (Deviation if any).

Justification for acceptance (if any deviation)

Review (Inclusive of follow up action, if any)

Recommendation

Signing off

2.1.

3.3 Any change in DQ should be through a change control

procedure as per SOP CQA-06 and should be

documented.

2.1.4 Factory Acceptance Test (FAT):

2.4.1 The FAT should be conducted at the supplier?s premises

under the users supervision unless agreed upon.

2.4.2 The FAT protocol / report should be prepared by the supplier

as per Manufacturers format and should be submitted for

approval of user.

2.4.3 The equipment should be shipped to the site only after

approval by the user.

2.4.4 The FAT protocol / report should include details of the URS

and FDS.

2.4.5 Any modification, changes needs during the FAT should be

documented and intimated to the user and carried out with

mutual consent.

2.1.5 Checklist on Receipt:

2.1.5.1 All critical parts of equipment should be checked for

finish, any damages on receipt for availability as per

packing list and order details.

2.1.6 Installation Qualification (IQ):

2.1.6.1 All aspects such as utility connections, location suitability,

material of construction of critical parts, installation of all

monitoring, controlling, instruments and gauges including

their calibration and certification by supplier should be

checked and verified.

2.1.6.2 During the installation qualification Area Lux level, Floor

drains, piping connections , machine alignment, levelling,

P& ID Diagram, Schematic, circuit diagram, tagging,

wiring pheruling, pneumatic connections considered

during design qualification are checked and verified.

2.1.7 Operation Qualification (OQ):

2.1.7.1 During Operation qualification the working of the

monitoring and controlling instruments, gauges and

systems like PLC, switches, gauges, motors, pumps etc.

are checked and certified.

2.1.7.2 The parameters considered during design qualification

are checked and certified.

2.1.8 PLC Validation

2.1.8.1 PLC validation should be carried out by competent

external approved agency.

2.1.8.2 PLC validation should be carried out during SAT or

subsequently within three months based on level of

checks carried out during SAT. Validation should be done

according to pre-approved protocol and report. All

reference instruments being used for validation should be

certified by approved agencies like …IDEMI? and …ERTL.

2.1.8.3 Brief description about equipment operating function and

its location should be mentioned in the report. All raw

data should be handwritten at site during actual validation.

2.1.8.4 The details of PLC and HMI hardware are checked as per

circuit diagram and type of PLC, HMI, its software Version

no. details, details of the available digital/ analogue inputs

and outputs. Installed switchgear details should be

mentioned i.e. SFU, MCB, relays, contactors, push

buttons, switch, power supply, Surge protection etc.

2.1.8.5 Equipment interlocks, alarms and operation logic should

be checked. Details of the PLC Battery conditions should

be checked and it?s life will be verified appropriately.

2.1.8.6 All PLC validation reports should be handed over by the

validation agency to the engineering department for

verification within a week after physical verification of the

system. Engineering, user department and quality

assurance department will verify submitted reports

2.1.8.7 Any deviation observed should be highlighted and brought

up to the notice of Engineering/ User/QA dept.

2.1.8.8 No changes should be made in the software or hardware

during the course of validation.

2.1.9 Site acceptance test (SAT) and Provisional Handover

Certificate:

2.1.9.1 SAT should be carried out in conjugation with the

supplier and may include checks of critical components,

controls based on the detail Fat, IQ and OQ have been

successfully performed.

2.1.9.2 After the equipment goes through the installation and

operational qualification procedure, it should be reviewed

at each stage by a team of Engineering, Production,

Quality Assurance, Quality Control, Safety and Unit Head.

2.1.9.3 In few cases the equipment may have to go through a

process cycle development and stabilisation phase before

subject to validation trials.

2.1.9.4 If any deviation or non conformance to the acceptance

criteria should be recorded and informed to concerned

supplier. A decision should be taken by user team and

supplier to reject or to proceed for PQ.

2.1.9.5 If SAT is found to be satisfactory, equipment should be

provisionally handed over to the concerned department

for Performance Qualification.

2.1.10 Performance Qualification (PQ):

2.1.10.1 During the Performance Qualification the working of the

system as a whole is checked with respect to out put, quality,

quantity and any specific requirements as per design

qualification.

2.1.10.2 Critical equipment should undergo extensive validation

studies to ensure consistent performance depending on

approved validation protocol.

2.1.11 Handover Certificate:

After successful Performance Qualification, based on review

by the team of Engineering, Production, Quality Assurance,

Quality Control, Safety and Unit Head. The equipment is

handed over to the concerned department for regular use. 2.2 Equipment Qualification and Requalification protocol consist of the

following sections.

Covering page

Table of contents.

Glossary

Pre approval

Design Qualification

Check list on receipt

Installation Qualification

Operation Qualification

Provisional Handover Certificate

Performance Qualification

Hand over Certificate

2.3 REQUALIFICATION / PERIODIC QUALIFICATION

2.3.1 All Major equipment should be requalified after any major

change in the equipment or modification.

2.3.2 If there are any major changes in critical parameters of equipment

(e.g. RPM of blender, speed of agitator etc.) which has direct

impact on the quality, then the revalidation of the process should be done.

2.3.3 The requalification need not be performed for any minor changes

in the equipment, For example, few blades of multimill are

replaced.

NOTE: Minor changes should be recorded in the Machine History Card.

2.3.4 If any fixed equipment is shifted from one area to another area.

Critical parameters should be checked during requalification.

Transfer note should be made for the equipment. It should be

kept along with the requalification record. For relocation of

portable equipment requalification is not required.

2.3.5 During the transfer of equipment from one unit to another unit

requalification as IO, OQ should be conducted based on critical

parameters. A such copy of original qualification should be

forwarded for reference.

2.3.6 While transferring the equipment to other area / units, review

should be done for any specific requirements of conditions

2.3.7 For equipment having no changes requalification time period

should be decided based on performance of annual review of the

equipment. The review of the equipment should be recorded in

the Equipment Review Report (Annexure MT95/A1) The

requalification time period should not exceed five years.

2.3.8 Schedule for requalification of the major equipment should

available at unit level and should be recorded in schedule for

requalification Annexure MT95/A2.

2.3.9 Schedule for PLC revalidation of the major equipment should be

available at unit level and should be recorded in Annexure

MT95/A3.

2.3.10 Any changes in schedule of equipment qualification should be

carried out through deviation.

Requalification / Periodic Qualification protocol consist of the following sections:

Covering page

Table of contents.

Glossary

Pre approval

Over view

Pre requisite

Preventive Maintenance verification

Major breakdown verification

System description

Physical verification

Calibration verification of critical components

Calibration verification of calibration standards used

Safety features verification

Control panel verification

Interlocks/controls verification

Performance evaluation Documentation verification Post approval

Hand over certificate

2.4 Protocol Approval:

2.4.1 All protocols are approved by Quality Assurance and Unit Head

prior to their implementation i.e. after they are compiled by a team of Production, Engineering, Quality Control and Safety.

2.4.2 Each protocol should be allotted with a protocol number in the

format specified bellow

“QUALI/X” Where,

“QUALI” stands for qualification

“X” stands for equipment / instrument / balance / area abbreviated code

2.4.3 The protocol should also be identified with a Version No., where

the version no. changes with every change in the Qualification, Requalification and Periodic Qualification of equipment.

2.4.4

The Qualification, Requalification and Periodic Qualification

protocol header should consist of the following details as mentioned below Title of the protocol Protocol No. Version No. Department Area Page No.

A specimen of the header is given below:

2.4.5 Frequency for Periodic Qualification

For Critical Equipment: Once in 3 years of its previous

qualification (Initial qualification / requalification)

For Non Critical Equipment: Once in 5 years of its previous

qualification (Initial qualification / requalification)

Note: The period of periodic qualification should be determined

based on review of history of preventive maintenance, breakdown,

calibration data and criticality of process.

3.0 ABBREVIATIONS:

URS User Requirement Specification

FDS Functional Design Specification

DQ Design Qualification

FAT Factory Acceptance Test

IQ Installation Qualification

SAT Site Acceptance Test

OQ Operation Qualification

PQ Performance Qualification

No. Number

P&ID Piping and Instrumentation Diagram

CER Capital Expenditure Requisition

CGMP current Goods Manufacturing Practices

PLC Programmable Logic Controller.

MOC Material of Construction材质

i.e. That is

e.g. For example

IDEMI Institute for Design of Electrical Measuring Instruments

ERTL Electronics Regional Testing Laboratory

PLC Programmable Logic Controller

HMI Human Machine Interface

SFU Switch Fuse Unit

MCB Miniature Circuit Breaker

4.0 REFERENCES:

CQA-06 Change Control

5.0 ANNEXURES:

MT95/A1 Equipment Review Report (MT95/F1)

MT95/A2 Schedule for Requalification/Periodic (MT95/F2)

Qualification

MT95/A3 Schedule for PLC Revalidation /Periodic (MT95/F3)

Validation