Prior to this, although regulatory guidelines concerning the use and validation of automated systems existed they had been subjected to less scrutiny than is the case today. In addition, as automated systems became more complex and more widely used the need to improve the overall understanding and interpretation of the regulations also increased.

In response to this the GAMP forum was set up to promote better understanding and interpretation of the regulations and improve communication within the pharmaceutical industry, it’s suppliers and the various regulators. The GAMP forum is now a technical subcommittee of the International Society of Pharmaceutical Engineering (ISPE).

Phase 1.

During the Planning and Definition SMB Validation & Compliance Services Group Inc is available to provide assistance to the equipment user in order to develop:

Validation Plan

SMB Group Inc. may be contracted to produce a validation plan, which summarizes the project, identifies the criteria for success and defines the criteria for project acceptance. Validation Plans are produced per Appendix M1 of the GAMP4 guidelines.

Once the project is completed a Validation Report can be produced to summarize the project, measure success and clearly signify acceptance. Validation Reports are produced per Appendix M7 of the GAMP4 guidelines.

User Requirement Specifications

Prior to accepting vendor bids on a project, SMB will put together a list of requirements for the planned system. The list incorporates the needs of the end users of the system as well as any regulatory requirements, division and local requirements. This document details what the customer wants the system to do. It does not provide design detail unless that detail represents a design requirement. Validation testing will be based partially on this document.

Supplier Assessment

For many projects, a supplier assessment or vendor evaluation (audit) utilizing a pre-approved supplier assessment procedure and criteria will be performed. SMB Group can develop and perform supplier assessments as required. Supplier Assessments are produced per Appendix M2 of the GAMP4 guidelines.

Risk Assessment + Critical Parameters

SMB Group is able to develop and manage the project Risk Assessment processes and help define the critical parameters of the project. Risk Assessments are produced per Appendix M3 of the GAMP4 guidelines.

Operation Qualification Protocols

SMB can develop an Operation Qualification Protocol, which provides a detailed written test protocol to verify the system operation against the various approved design specifications. All control functions are verified. E-stops and interlocks are checked for functionality. All machine functions are tested and all devices challenged to ensure that design criteria have been achieved.

Performance Qualification Protocols

In process or performance qualification protocol are developed and performed. SMB can develop and offer assistance during this process.

Developing a Supplier Quality Plan is a key aspect of any project. SMB Group may be utilized to prepare and monitor a project quality plan. Supplier Quality Plans are produced per Appendix M6 of the GAMP4 guidelines.

Functional Design Specification:

The Functional Design Specification provides a written definition of what the system does, what functions it has and what facilities are provided. Functional Design Specifications are produced per Appendix D2 of the GAMP4 guidelines.

Acceptance Test Specification:

The acceptance criteria for this test is based on requirements originally agreed upon and documented in the Functional Requirements Specification and detailed in an approved written test protocol. Depending upon the complexity of the project this activity may be divided into Factory Acceptance testing and Site Acceptance testing. Acceptance Test Specifications are produced per Appendix D6 of the GAMP4 guidelines.

Hardware Design Specification:

The Hardware Design Specification provides a detailed written definition of the system hardware, how the hardware interfaces to other systems. Hardware Design Specifications are produced per Appendix D3 of the GAMP4 guidelines.

Hardware Test Specification:

The Hardware Test Specification provides a detailed written test protocol to verify the system hardware against the design specification. Hardware Design Specifications are produced per Appendix D3 of the GAMP4 guidelines.

Software Module Specifications:

The Software Module Specification provides a written definition of what the system should do, and the interfaces between the modules. Software Module Specifications are produced per Appendix D4 of the GAMP4 guidelines.

Software Module Test Specifications:

The Software Module Specification provides a detailed written test protocol to verify the individual software modules against the design specification. Software Module Test Specifications are produced per Appendix D6 of the GAMP4 guidelines. Note: Depending upon the complexity of the project the hardware and software test specifications may be consolidated into a single test specification. Note: Depending upon the complexity of the project the functional design specification, hardware design specification and software design specifications may be consolidated into a single detailed design specification.

Installation Qualification Protocols:

SMB can develop an Installation Qualification Protocol, which provides a detailed written test protocol to verify the system installation against the various approved design specifications. SMB can develop an Operation Qualification Protocol, which provides a detailed written test protocol to verify the system operation against the various approved design specifications. All control functions are verified. E-stops and interlocks are checked for functionality. All machine functions are tested and all devices challenged to ensure that design criteria have been achieved.

Performance Qualification Protocols:

In process or performance qualification protocol are developed and performed. SMB can develop and offer assistance during this process. SMB can develop an Operation Qualification Protocol, which provides a detailed written test protocol to verify the system operation against the various approved design specifications. All control functions are verified. E-stops and interlocks are checked for functionality. All machine functions are tested and all devices challenged to ensure that design criteria have been achieved. Performance Qualification Protocols In process or performance qualification protocol are developed and performed. SMB can develop and offer assistance during this process.

Hardware Acceptance Testing provides a detailed written test protocol to verify the system operation against the various approved design specifications. Correct operation of the hardware and instrumentation as defined in the hardware design specification is verified. Hardware Acceptance Tests are produced per Appendix D6 of the GAMP4 guidelines.

Software Module Testing

Software Acceptance Testing provides a detailed written test protocol to verify the system operation against the various approved design specifications. Correct operation of the software as defined in the software design specification is verified. Software Module Tests are produced per Appendix D6 of the GAMP4 guidelines.

Integration testing

Integration tests can be developed and performed prior to execution of a factory acceptance test. Integration tests verify that the requirements for the system are met. The acceptance criteria for this test is based on requirements originally agreed upon and documented in the various design specifications.

Note: Each GAMP test stage is duly considered during validation and test planning and may, depending upon the customers Quality Assurance function, meet the requirements of the IQ, OQ & PQ as summarized above.

Note: Depending upon the complexity of the project these test phases may be consolidated into a single Site Acceptance test.

Once the system is constructed and just prior to shipment, we will perform a factory acceptance test in which we verify that the requirements for the system are met. The acceptance criteria for this test is based on requirements originally agreed upon and documented in the various design specifications and detailed in a previously approved written test protocol.

All data pertaining to the identification of the equipment (model number, serial number, power rating, control systems I.D. numbers, etc.) is recorded to ensure full trace-ability. PLC addresses are verified for correct wiring. Verification for compliance against the Functional and Design Specifications is carried out. Additional information such Standard Operating Procedures listing, Purchase Order verification and Preventive Maintenance review is also typically included.

Operation Qualification Implementation

All control functions are verified. E-stops and interlocks are checked for functionality. All machine functions are tested and all devices challenged to ensure that design criteria have been achieved.

Performance Qualification Implementation

Bracketing is used to qualify ranges of products. Performance Qualification is also to validate a complete integrated process (e.g. a packaging line consisting of several pieces of equipment).

Validation Report

Once the system has been successfully qualified, a Validation Report will be prepared to confirm that the system is ready for use for purpose.

Change Control is fundamental to maintaining the validated status of a process and/or products and as such will be defined in the Quality and Project plans. The point of transfer from Project Change Control to Operational Change Control is typically defined in the Validation Plan. SMB Group can develop, detail and maintain Change Control throughout the system lifecycle. Operational Change Control Plans are produced per Appendix O4 of the GAMP4 guidelines.

Periodic Reviews

Periodic Reviews and evaluations of automated systems should be conducted jointly by the System Owner and user Quality Assurance group. Although the final responsibility for ensuring the compliance and correct operation of a system lies with the System Owner, SMB Group can provide compliance input and provide an independent perspective to the process.

Periodic Reviews are produced per Appendix O1 of the GAMP4 guidelines.

System Security

The User Company Management is ultimately responsible to ensure that automated systems and the data produced or contained within are adequately and securely protected against both willful and accidental loss, damage or unauthorized change. SMB Group can develop and detail a System Security Plan. System Security Plans are produced per Appendix O3 of the GAMP4 guidelines.

Back Up & Disaster Recovery

SMB Group can develop and detail a Back Up and Disaster Recovery Plan. Back Up and Disaster Recovery Plans are produced per Appendix O7 of the GAMP4 guidelines.

Trace-ability Matrix

SMB Group provides a trace-ability matrix to establish the relationships between the various products of the development process. Trace-ability matrices detail design relationships and the verification of each. A trace-ability matrix is a live document used throughout the development process, beginning with the User Requirement Specification and maintained through to the approval of the final test specifications.