IV.3.Maintenance V.0Life-Cycle

IV.3.Maintenance

V.0Life-Cycle

V.1.Development

The Supplier shall provide a Quality and Project Plan as part of their proposal. The Supplier shall have a quality system in place. Internal quality procedures shall be available for the User’s review.

The Supplier shall provide a Project Manager for the project to provide a single communication point with the User.

The project shall utilize the GAMP methodology when developing the system and documentation.

V.2.Testing

In order to verify system performance, the User shall witness the execution of the Factory Acceptance Test procedures. The Supplier shall notify the User _______ weeks in advance of the start of this test.

The Factory Acceptance Test Specification shall be submitted to the User for review and approval prior to execution. A minimum of _______ weeks shall be allowed for the User to review and to comment and/or approve the Factory Acceptance Test Specification.

Refer to the Equipment Validation Plan for applicable procedures.

V.3.Delivery

V.3.1.Documentation

The Supplier shall use the formats described in the GAMP Supplier Guide, Current Version, to produce the documentation. The Supplier shall provide the documentation for preliminary review. The Supplier shall provide documentation reflecting “as-built” condition with final delivery.

All final documents shall be shipped with transmittals that identify them as contractually required documents. All final documents and drawings shall reflect “as-built” condition.

All documents shall in the language of the destination country and supplied with hard copies and electronic versions supplied in the format identified for each document:

• 
  Project Plan Microsoft Word 97 (*.doc)
  
• 
  User Requirements Specification Microsoft Word 97 (*.doc)
  
• 
  Functional Specification/Requirements Microsoft Word 97 (*.doc)
  
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  Design Specifications Microsoft Word 97 (*.doc)
  
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  Controls Test Microsoft Word 97 (*.doc)
  
• 
  Hardware Installation Test Microsoft Word 97 (*.doc)
  
• 
  Operational Test Microsoft Word 97 (*.doc)
  
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  Factory Acceptance Test Microsoft Word 97 (*.doc)
  
• 
  Operator, Maintenance and Service Manuals Microsoft Word 97 (*.doc)
  
• 
  Process and Instrumentation Diagram (P&ID) AutoCAD version 12.0 (*.dxf)
  
• 
  Instrument Listing Microsoft Word 97 (*.doc) or Excel 97 (*.xls)
  
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  Control Schematics AutoCAD version 12.0 (*.dxf)
  
• 
  Control Panel Assembly Drawings AutoCAD version 12.0 (*.dxf)
  
• 
  Equipment Assembly Drawings AutoCAD version 12.0 (*.dxf)
  
• 
  Bill of Materials Microsoft Word 97 (*.doc) or Excel 97 (*.xls)
  
• 
  Spare Parts List Microsoft Word 97 (*.doc) or Excel 97 (*.xls)
  
• 
  Component Cut Sheets Microsoft Word 97 (*.doc) or Excel 97 (*.xls)
  
• 
  CONTROL PLATFORM Program
  Printout and Disk File XXX Program Development format
  
• 
  OIP Configuration Printout and Disk File XXX Program Development format
  

V.4.Support

V.4.1.Start-up Support (list available options)

V.4.1.1.Training (list training options available)

V.4.2.Post Start-up Support (list post-startup support available)

V.4.2.1.Technical Support

Telephone (Voice or Modem)

Replacement Parts Availability List (Normal lead times shall be listed)

V.4.2.2.User Site Support

Preventative Maintenance (list maintenance contracts available)

System Improvements (supplier shall notify user of any improvements available on a regular basis)

VI.0Glossary

VI.1.Terminology

{If necessary, attach a glossary of terms that may be unfamiliar to the Supplier (or other document readers) and/or terms that may have meanings specific to entries in this User Requirements Specification. For example (example list is not intended to be complete):}

Term	Definition
Alarm Log	A listing that is a permanent record of alarm activities within a defined period. The listing is a replica of sequential alarm events, normally including the activation and acknowledgement activities.
Alarm Summary	A listing of alarms that are currently in active and/or have been yet been acknowledged. The listing is not a permanent record alarm-related events.
Basic Control	Control that is dedicated to establishing and maintaining a specific state of equipment.
Batch	The material that is being produced or that has been produced by a single execution of a batch process.
Batch Process	A process that produces a specific quantity of product by subjecting specific quantities of raw materials to a defined order of discontinuous processing actions over a period of time using one or more pieces of equipment.
Control Module	A regulating device, a state-oriented device, or a combination of regulating and state oriented devices that are controlled as a single device.
Control Recipe	A type of recipe, which, through its execution, defines the manufacture of a single batch of a specific product. The control recipe contains the specific processing requirements for the actual batch, raw materials, and product. It is a copy of a master recipe made unique through the assignment of a lot number.
Coordination Control	A type of control that directs, initiates, and/or modifies the execution of procedural control and the utilization of equipment entities.
Equipment Control	The equipment specific functionality that provides the actual control capability for an equipment entity, including procedural, basic and coordination control, which is not part of the recipe.
Equipment Module	A functional group of subordinate equipment modules and/or control modules that can carry out a specific minor processing activity such as producing individual CIP fluids.
Life-Cycle	A series of stages through which a system passes during its lifetime.
Lot Number	An alphanumeric set of characters that uniquely identify and specify the product that is produced at a specific unit operation.
Master Recipe	A type of recipe that accounts for equipment capabilities and may include process cell-specific information. The master recipe is used as a template for creation of a control recipe.
Operation	A procedural element defining an independent processing activity consisting of the algorithm necessary for the initiation, organization, and control of phases. An example might be CIP.
Phase	A procedural element that provides an interface to basic control. Examples might be wash, fill, rinse.
Procedural Control	Control that directs equipment oriented actions to take place in an ordered sequence that can carry out some process-oriented task.
Procedure	A manufacturing procedure that has one or more operations and product specific recipe data.
Process Stage	A part of the process that usually operates independently from other process stages and that usually results in a planned sequence of chemical or physical changes in the material being processed.
Recipe	The necessary set of information that uniquely defines the production requirements for a specific product or unit operation. SP-88 defines four levels of recipes. The general recipe is the highest order recipe, followed by the site recipe, the master recipe, and the control recipe. SP-88 is flexible in that, depending on the needs of the enterprise, more levels of recipe may be used, or that all levels need not be implemented. Procedural control requirements specify procedures, unit procedures, recipe operations, and phases. The control recipe specifies these even further for the actual equipment. The procedural control component of the recipe contains one or more procedures, which contain one or more unit procedures, which contain one or more operations, which contain one or more phases.
Recipe Management	The control activity that includes creating, editing, storing and retrieving master and control recipes.
S88.01	Part 1 of an Instrument Society of America standard that describes models and terminology for batch control systems.
Unit	A Unit is comprised of all the equipment that works together to carry out a major independent process activity. A unit may contain one or more equipment modules and/or one or more control modules.
Unit Procedure	A production sequence (consisting of contiguous operations and the algorithm necessary for the initiation, organization, and control of those operations) executed within a unit.
Working Recipe	A working recipe is the control recipe loaded into the MES for control of production. The technician during production of a batch may alter it.

VI.2.Acronyms

{If necessary, attach a list of acronyms that may be unfamiliar to the Supplier (or other document readers) and/or acronyms that may have meanings specific to entries in this User Requirements Specification. For example (example list is not intended to be complete):}

Acronym	Full Spelling	Definition
ANSI	American National Standards Institute	An organization that produces standards, practices, and codes related to pharmaceutical manufacturing.
degC	Celsius (centigrade)	A unit of temperature measurement.
CFR	Code of Federal Regulations	Written version of the national laws of the United States of America.
cGMP	current Good Manufacturing Practices	A set of regulations governing the manufacture of pharmaceutical products.
CPG	Compliance Policy Guide	US FDA Publications that supplement and/or explain and/or interpret specific requirements from the Code of Federal Regulations(CFR)
DCS	Distributed Control System	A proprietary automation solution providing I/O monitoring and control equipment with a tightly integrated HMI and ancillary applications (trending, redundancy, etc.).
EBR	Electronic Batch Record	A collection of production data stored in secure electronic (digital) form.
EPA	Environmental Protection Agency	A United States agency responsible for environmental protection.
degF	Fahrenheit	A unit of measure for temperature.
FDA	Food and Drug Administration	A United States agency responsible for consumer safety related to drugs and drug products.
GAMP	Good Automated Manufacturing Practices	A methodology for implementing and documenting automated systems.
GUI	Graphical User Interface	An application resident on an Operator Interface that provides a pictorial interface for process monitoring and control.
HMI	Human-Machine Interface	A PC-based graphical user interface used for monitoring and controlling an industrial process.
I/O	Input/Output	The hardware required to convert field signals to/from a computer-usable form.
IEEE	Institute of Electrical and Electronics Engineers	An organization that produces standards related to electrical and electronic components, including networking.
IQ	Installation Qualification	Approved documented verification that an object or system is installed according to written and approved specifications and drawings.
IS	Intrinsically Safe	Standards related to equipment and wiring installation in explosive or potentially explosive environments.
ISA	Instrument Society of America	An organization that produces standards related to process control and instrumentation.
ISO	International Standards Organization	An organization that produces standards, practices, and codes related to pharmaceutical manufacturing.
JETT	Joint Equipment Transition Team	A consortium of pharmaceutical users (manufacturers), equipment suppliers, and consultants seeking to improve communications between Users and Suppliers to more effectively meet the "validation" requirements of the pharmaceutical industry.
LAN	Local Area Network	A group of computers connected to facilitate computer-to-computer communications.
LCL	Lower Control Limit	The minimum parameter value required to assure that a product is manufactured according to specifications.
LIMS	Laboratory Information Management System	A software system used to store and retrieve laboratory information related to sampling, testing, and product release.
MES	Manufacturing Execution System	One or more software products or applications responsible for transferring data between plant floor production systems and higher-level business application systems.
MMI	Man-machine Interface	see HMI.
MSDS	Material Safety Data Sheet	Documentation of the chemical and hazardous properties of a substance.
NDA	New Drug Application	A process prescribed by the US FDA for introducing a new pharmaceutical product or product form to the US marketplace.
NEC	National Electric Code	United States Standards governing the design, installation, and use of electrical equipment.
NEMA	National Electrical Manufacturers Association	An organization that, among other activities, defines categories of environment resistance for electrical equipment.
OEM	Original Equipment Manufacturer	The supplier of industrial equipment packages that are typically skid-mounted and include pre-wired instrumentation and control components.
OQ	Operational Qualification	Approved documented verification that an object or system operates in accordance with written and approved specifications throughout all anticipated operating ranges.
OSHA	Occupational Safety and Health Act	United States regulations related to work places and practices.
P&ID	Piping and Instrumentation Diagram	Engineering drawings that present basic process information, especially instrument and sensor locations.
PC	Personal Computer	A microcomputer designed primarily for use by a single individual.
PLC	Programmable Logic Controller	A device that provides control functionality via software. It is typically programmed in ladder logic and replaces relays, electrical devices, timers, counters and analog instrumentation.
SCADA	Supervisory Control and Data Acquisition	A SCADA system provides communication between supervisory applications (e.g., HMI or batch management) and plant floor control devices, typically PLCs.
SKU	Stock Keeping Unit	A number or other identifier used to distinguish packaging and/or product forms.
SOP	Standard Operating Procedure	Site instructions for operating and maintaining the facility and process.
SQL	Structured Query Language	A standard syntax used to extract selected data from a database.
TCP/IP	Transmission Control Protocol / Internet Protocol	A routable computer communication protocol.
UCL	Upper Control Limit	The maximum parameter value required to assure that a product is manufactured according to specifications.
UPS	Uninterruptable Power Supply	Battery-based system for providing electrical power during temporary power outages.
WFI	Water For Injection	Highly purified water suitable for use in the production of products that may be injected into a human body.

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