An Automated Solution Prep Suite

As part of the expansion of its local manufacturing capacity, a major pharmaceutical company constructed a new facility in North Ryde, NSW. This facility contains suites used for the manufacture of existing and new pharmaceutical products for domestic and export customers.

The suites concerning this project are used to manufacture sterile solutions suitable for human injection.

The scope of the project was the design, testing and documentation of the SCADA, PLC, Report and Database related software for 3 of these suites. This included the development of custom software for simulation testing. The project covered the full life cycle from Tender through to Handover to Validation.

The project followed a GAMP standard V model and consisted of the following phases:

URS - User requirements specification, development of a User Requirements Specification and a Scope of work document to cover additional contractual details.

TENDER - This involved producing a report on the abilities of the various short listed subcontractors and a decision matrix to ensure a fair assessment based on prioritized criteria. This included a Project Plan, Resources Base, Service abilities, Pricing, Quality system, Experience.

QUALITY PLAN - It was necessary to produce a specific quality plan to impose the required controls on the development and documentation phases for the project.

FDS - Production of a Functional Design Specification this included an appendix of Sequence logic separately controlled as an SDS Software Design Specification.

SMDS - Software Module Design Specification, this detailed in a top down manner the structure, precise logic and addressing of the functions used to implement the requirements.

STS - Software Test Specification, this contained the plan for the testing including the systems to be utilized and the methodology. Including testing of the testing tools.

FAT Test Document (Factory Acceptance Testing). This document was accompanied by an FAT test results file which together detailed the exact tests performed, the acceptance criteria and evidence of the tests being completed successfully. This testing utilized 6 PC's as follows:

1) PC with custom written VB Spreadsheet to record I/O activity.
2) PC to act as SCADA station
3) PC to act as redundant SCADA I/O server
4) PC to act as SQL server (Database for reports)
5) PC to view and capture PLC logic performance.
6) PC to run custom written simulation software (separate lifecycle)

SAT Test Documents (Site Acceptance Testing)
This phase of testing aligned with the SDS component of the FDS and the SMDS, SAT Testing. This testing involved the testing of the software onsite. This testing aligns with the FDS. Upon completion of the SAT testing the project was handed over to Validation.

LSP- Learner Session Plan. This extensive document was a training tool produced for the end user's engineers. The document in electronic form contained links to all related documents and as such became expanded to act as an electrical and mechanical knowledge base.

REVIEW DOCUMENT- This detailed the reviews performed on each of the phases and associated documents, It also served as a traceability matrix to relate sections of different documents to each other.

Project statistics

The project resulted in some valuable software tools and templates being available to other projects. These included a package to record and playback in realtime PC screens giving unprecedented evidence of testing, as well as an Excel spreadsheet that records PLC I/O activity in this case it was used as a valve matrix to record valve operations with sequence steps.

This project was hailed as an outstanding success as the software cost less than any previous suites, was completed in far less time and broke all previous records for SAT / commissioning and Validation performance.

The project gave Fast Automation exposure, experience and the opportunity to demonstrate it's ability to policing subcontractors in pharmaceutical standards in the following areas:

• Change Controls
• Document Control
• SOP's
• Quality Planning
• Project Management
• Following a V- Model
• Design Reviews
• Acceptance Testing
• Validation of Computerised Systems

Standards

• Australian Code of Good Manufacturing Practice for Therapeutic Goods
• EU Guide to GMP for Medicinal Products, Annex 1 - Manufacture of Sterile Medicinal Products, January 1999
• GAMP3- Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture - 1998