urs template contents

12

Click here to load reader

Upload: ipatoff

Post on 17-Feb-2016

173 views

Category:

Documents


19 download

DESCRIPTION

URS

TRANSCRIPT

Page 1: Urs Template Contents

JETT URS ContentsBlank Template

Page 1 of 8Doc ID: Blank Template URS Contents

Revision 0Revision Issued - June 2004

The URS contents template is designed to be used in conjunction with the URS blank template developed by the Joint Equipment Transition Team (JETT) in accordance with current GAMP guidance. The numbering system used in the URS contents template match the sections by number in the JETT URS blank template. The URS contents template only includes the following sections:

1.0 Introduction (Scope)2.0 Overview3.0 Operational Requirements

The other sections included in the URS blank template are typically boiler-plate and will only require minimal modification for specific end users.

The electronic versions of the JETT documents (URS contents template and URS blank template) are available at no cost on the JETT website (http://www.jettconsortium.com/).

The information presented in this URS contents document is designed to be utilized (cut/pasted) into the current JETT URS template or specific end-user URS templates.

REVISION HISTORY

Rev. Date Developed By: Revision Summary

0 June 2004 JETT Initial Release

1.0INTRODUCTION (SCOPE)Note: Insert your own description and introduction. You may wish to include your own requirements and specifics to provide the inexperienced reader, contractors, and suppliers an adequate explanation to understand the scope of the equipment.

Describe who produced the document, under what authority, and for what purpose.

Describe the contractual status of the document. Include or reference as an attachment the “legal” paragraph that communicates purchasing terms and conditions in this section.

Describe the relationship of this document to other documents. This is important for equipment that is part of an integrated process or line and will help the Supplier to understand and ask questions that may otherwise be overlooked.

Refer to the Equipment Validation Plan that outlines the Supplier’s responsibilities is attached.

Remove any options that are not applicable for this project, if other uses will apply list each separately.

This is to be utilized as a guide for the user to answer the majority of questions involved in specifying the “what” for the equipment. Addendums may be used to round out the requirements.

JOINT EQUIPMENT TRANSITION TEAM

Page 2: Urs Template Contents

JETT URS ContentsBlank Template

Page 2 of 8Doc ID: Blank Template URS Contents

Revision 0Revision Issued - June 2004

2.0OVERVIEWThis document encompasses the normal range of equipment operations. This section should be expanded to provide a high level description of the system explaining why it is required and what is required of it. Include the background, key objectives and benefits, main functions and interfaces, applicable GxP requirements, and other applicable regulations. Obviously, technology improvements and new applications may require deviation from this template.

The User should consider including information on the following:

2.1 Use: Describe what applications the equipment/system will be used to support. Include a brief explanation of the general functions.For example (for a Wide Range Filler):

2.1.1 The wide range filler line shall process pharmaceutical vials under sanitary conditions with the following functions: vial filling, put stoppers to vials, oxygen reduction, sample check weighing, and vial eject.

For equipment dealing with solid dosage pharmaceutical products directly:

2.1.1 The products being developed on the specified equipment are of:

2.1.1.1 Low active (vitamins, supplements)2.1.1.2 Medium active (e.g. Aspirin)2.1.1.3 Highly active (e.g. Morphine)2.1.1.4 Exclusive (e.g. Penicillin)

2.2 Capacity: Provide a brief description of the equipment/system capacity requirements.For example (for a Wide Range Filler):

2.2.1 The equipment shall be capable of producing XYZ product continuously, over an 8-hour shift.

JOINT EQUIPMENT TRANSITION TEAM

Page 3: Urs Template Contents

JETT URS ContentsBlank Template

Page 3 of 8Doc ID: Blank Template URS Contents

Revision 0Revision Issued - June 2004

3.0OPERATIONAL REQUIREMENTSThis Section shall state the operational requirements: system functions, data and interfaces. It shall also define the environment in which the system must operate. Critical requirements shall be specifically identified as such. Include process descriptions and flowcharts as appropriate.

3.1 Capacity

3.1.1 Range of products

3.1.2 Commodities to be used (i.e. vials, bottles, tablets, etc.)

3.1.3 Processed Materials to be used or involved

3.1.4 Production rates

3.2 Process Requirements

3.2.1 Quality of products and concentrations

3.2.2 Product limitations (i.e. temperature, humidity, pH, etc.)

3.3 Process Control

3.3.1 Measurement Range

3.3.2 Setpoint Range

3.3.3 Parameter Control Tolerance

Note: At a minimum, list the critical, process parameters. Consider documenting how each of the parameter requirements was determined.

3.4 Functions

3.4.1 Operation

Enter your specific operational requirements here.

3.4.1.1 Cycles expected the system will operate at are…

3.4.1.2 Recipes the system will contain are…

3.4.1.3 Operator interaction with the system will include…

The following is an example:

3.4.1.1 The system shall operate with a minimum of operator involvement. Operation shall be safe from an operator and environmental standpoint.

3.4.1.2 The system shall be operated locally at the equipment itself.

Control system requirements:

3.4.1.4 Manual only

3.4.1.5 Manual/automatic

JOINT EQUIPMENT TRANSITION TEAM

Page 4: Urs Template Contents

JETT URS ContentsBlank Template

Page 4 of 8Doc ID: Blank Template URS Contents

Revision 0Revision Issued - June 2004

3.4.2 Power failure/Recovery

3.4.2.1 Power Failure: Insert your specific power failure/recovery scheme here.

For example:

In the event of a power failure, the system shall protect in the following priority:

3.4.2.1.1 Personnel

3.4.2.1.2 Equipment

3.4.2.1.3 Product

3.4.2.2 Recovery Methods: Insert your specific recovery scheme here.

For example:

3.4.2.2.1 Manually re-start based on operator inputs (Operator initiates power recovery sequence).

3.4.2.2.2 Re-start based on last state before loss of power. (System runs through power recovery sequence when operator start signal is given)

3.4.2.2.3 If there is an automatic batch reporting system, the information shall be retained in the event of a power failure (A UPS is required for automatic batch reporting systems for data retention).

3.4.3 “Emergency Stop”

Insert your specific “Emergency Stop” (E-Stop) strategy and communication scheme here.

For example:

3.4.5.1 The system shall have an E-Stop mechanism designed to stop all physical movement of the equipment immediately. The E-Stop mechanism(s) shall be located in easily accessible areas around the equipment as required by national and local safety standards.

3.4.4 Alarms and Warnings

3.4.4.1 “Critical alarms” - Insert your specific “Critical Alarm” action scheme here.

For example:

3.4.4.1.1 Critical Alarms shall take action via interlock(s) and/or operator procedural response to shut the equipment down and notify the operator of the condition(s). The operator shall be required to acknowledge the alarm before the alarm can be

JOINT EQUIPMENT TRANSITION TEAM

Page 5: Urs Template Contents

JETT URS ContentsBlank Template

Page 5 of 8Doc ID: Blank Template URS Contents

Revision 0Revision Issued - June 2004

reset and the system restarted. Once the alarm is reset, the operator may restart the system.

3.4.4.2 “Informational Messages” shall notify the operator and take no further action.

Note: For a customized equipment application, include an alarm table, like the example that follows.For example:

3.4.4.2.1 The Equipment shall have the following critical alarms and warnings:

Alarm or Informational Message Critical Alarm

Stackpole Light

Illumination (color/flashin

g)

Informational Message

Response

Interlock(s) Operator Procedural

Emergency Stop X X

Control Platform Communication Watchdog X X

Control Power Fault X X

Main Air Fault X X

XXXX X

YYYY X

ZZZZ X

Motor Faults X X

CONTROL PLATFORM Battery Low Warning X X

The list of critical alarms in the table is not intended to be a comprehensive list of all alarms for the system. A complete alarm list will be developed and included in the Functional Specification document.

For a standard equipment type application, request the supplier to submit the complete alarm list and differentiate between critical and non-critical alarms.

Note: Consider documenting how “critical and informational message” criterions were determined.

3.5 Data and Security

Controls provided with Data Collection systems intended for use in the manufacture of pharmaceutical products shall be required to meet 21 CFR Part 11 compliance.

3.5.1 User Interfaces

This section should address the following issues:

3.5.1.1 User interface access levels

JOINT EQUIPMENT TRANSITION TEAM

Page 6: Urs Template Contents

JETT URS ContentsBlank Template

Page 6 of 8Doc ID: Blank Template URS Contents

Revision 0Revision Issued - June 2004

3.5.1.2 Frequency of data point collection3.5.1.3 Hardcopy/electronic data collection requirements3.5.1.4 Compliance with 21CFR Part 11 (for Europe - EREC Guidelines)3.5.1.5 Data retention time on the system3.5.1.6 Data storage media

Access to all Input/Output values and system status bits shall be provided through a data-communication link. Security for data and operator access is provided by (User ID/Password, Card Reader, Biometric (Fingerprint, eye scan, voice recognition, etc.).

3.5.2 User Interface with Supervisors and Operators

Insert your interface scheme here.

For example:

3.5.2.1 The CONTROL PLATFORM system shall include interfaces with the Operator and Supervisor that ensures easy, safe, and reliable operation.

3.5.2.2 An operator-interface panel shall be provided and mounted near the equipment or on the equipment. This panel shall provide the necessary switches, indicators, and devices to operate the equipment.

3.5.3 Language requirements

Specify language that information will be displayed in (i.e. English, Spanish, German, Bilingual, etc.)

3.5.3.1 Displayed Requirements:State the system of measurement that will be used (English or Metric (S.I.)).

Parameter Format Unit(s) of measurement

XXXXXXX (###.#) units units

YYYYYYY (##)% %

3.5.4 Interface with Other Equipment

The control system shall include the interfaces necessary to facilitate operation and configuration. For example:

3.5.4.1 An RS-232 communications port shall be provided.3.5.4.2 A Modem communications port shall be provided.3.5.4.3 A high-speed configuration/monitoring connection shall be

provided.3.5.5 Security Levels

List the total number of different access levels that will be required. Provide a general description of the access rights for each level (screen navigation, operational control, control loop variable manipulation, alarm setpoint manipulation, etc.).

JOINT EQUIPMENT TRANSITION TEAM

Page 7: Urs Template Contents

JETT URS ContentsBlank Template

Page 7 of 8Doc ID: Blank Template URS Contents

Revision 0Revision Issued - June 2004

3.5.6 Data Collection

Consider any archiving and reporting requirements here.

3.5.6.1 None3.5.6.2 Recorder3.5.6.3 Process Printout3.5.6.4 Electronic process printout, Historical Trending3.5.6.5 Electronic process printout, Historical Trending and interface to

company networkThe following shall be recorded:

3.5.6.6 XXXXX3.5.6.7 YYYYY3.5.6.8 ZZZZZ

3.6 Environment

Provide details of the physical environment in which the [equipment/system] will be operated.

3.6.1 Layout

For example:

3.6.1.1 Allocated floor space for the equipment is _____ inches by ________ inches with at least a _______inch corridor around the periphery for the equipment.

3.6.1.2 Vertical clearance is _________ inches.3.6.1.3 Floor Loading is pounds/ft23.6.1.4 See attached drawing #________________________ (if

applicable).Layout is specific to the size equipment being used and system requirements of the equipment.

3.6.2 Physical Conditions

3.6.2.1 Room Explosion ClassificationList the critical explosion requirements for the room.

3.6.2.1.1 Room will be non-hazardous

3.6.2.1.2 Room will be Class I Div II (Zone 2) (explosive atmosphere present at known times)

3.6.2.1.3 Room will be Class I Div I (Zone 1) (explosive atmosphere present at all times)

3.6.2.2 Environmental ClassificationList the critical air quality requirements for the environment.

3.6.2.2.1 ISO Class 5, 7, or 8 (ISO 14644-1 and ISO 14644-2)

JOINT EQUIPMENT TRANSITION TEAM

Page 8: Urs Template Contents

JETT URS ContentsBlank Template

Page 8 of 8Doc ID: Blank Template URS Contents

Revision 0Revision Issued - June 2004

3.6.2.2.2 Class A, B, C, or D (The Rules Governing Medicinal Products in the European Union – Annex 1)

3.6.2.2.3 Directional airflow

3.6.2.2.4 Airflow velocity

3.6.2.2.5 Number of air changes

3.6.2.2.6 Particle Ingress3.6.2.3 Biohazard Level

List the critical biohazard level requirements for the environment.

3.6.2.3.1 BL-1

3.6.2.3.2 BL-2

3.6.2.4 Rating of enclosuresList the rating requirements for enclosures in the environment.

3.6.2.4.1 NEMA 1 (Open)

3.6.2.4.2 NEMA 12 (Oil tight)

3.6.2.4.3 NEMA 4 (Wash down)

3.6.2.4.4 NEMA 4X (Wash down and non-Corrosive)

3.6.3 Cleaning Requirements

3.6.3.1 Hand-Wash

3.6.3.2 Auto-Wash

3.6.3.3 Steam Clean

3.6.4 Sterilization Requirements

Describe the type of sterilization that will be performed on or within the [equipment/system] and the duration the [equipment/system] will be exposed.

3.6.5 Intended Operating Environment:

Describe the type of operating environment that the [equipment/system] will be exposed to following installation.

For example:

3.6.5.1 The [equipment/system] shall be mounted in a GMP environment with a temperature range of 15 to 25 °C, non-condensing humidity.

3.6.5.2 Vibration levels in operating environment are <Negligible, Slight, or Severe>

3.6.5.3 The Seismic Zone in the operating environment is <Zone 1, Zone 2, Zone 3, Zone 4, or Zone 4A>.

JOINT EQUIPMENT TRANSITION TEAM