SPGL has a leading edge in the industry, having developed a proven methodology for integrating Commissioning & Qualification “C&Q”.

Click here to view the Integrated Commissioning and Qualification Flow Diagram

We have learned from experience that significant cost and schedule savings can be realised from the integration of engineering, construction, commissioning and qualification activities to address the buildings and all systems (Direct Impact, Indirect Impact, and No Impact) that comprise a pharmaceutical / biotech project.

During project execution, our strategy is to closely integrate Construction with Commissioning and to utilise the project’s enhanced commissioning process to reduce the time taken for Qualification, hence reducing Time-to-Market.

Our strategy for Construction Quality is to apply regulatory compliance principles to construction activities to ensure a smooth transition into Commissioning. Our Construction Quality program (see section 5.3 for details) ensures proper Construction turnover and that systems are ready for Commissioning. We then perform Enhanced Commissioning to ensure that Commissioning activities and documentation can be leveraged into Qualification.

This philosophy is based on the concept that a properly executed and documented commissioning effort will expedite plant delivery. Often the problems that are encountered in Qualification are due to incomplete Commissioning procedures.

We strongly believe that a fully executed and properly documented Commissioning can eliminate many downstream problems and accomplish much of the data gathering required for Qualification and plant delivery. By reducing the time for Qualification, we lower project cost and save time within the overall project schedule.

Properly planned commissioning should begin during the pre-construction phase of a project or as early as possible. Therefore, we will identify the parameters for Commissioning and Qualification turnover documents during the pre-construction phase of a project.

Factory Acceptance Test (FAT) plans and Site Acceptance Test (SAT) plans will be developed for pre-purchased equipment and systems. Our goal will be to have the commissioning and closeout documentation requirements.

In order for documented commissioning to work effectively as the basis for Qualification, early active participation of the Client's quality unit is key to ensuring that various commissioning activities are eventually accepted for inclusion in support of the Installation and Operational Qualification. This is in accordance with the framework set forth in the ISPE Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities, Volume 5, Commissioning and Qualification.

Documented Commissioning must be treated as a unique and discrete activity in accordance with the above definition to be used as the basis of Qualification. In many cases, where attempts were made to mix commissioning and qualification together serious delays and shortfalls occurred.

This has the following advantages:

• The Qualification protocol will be of very high quality since the protocol has been executed and improved already during commissioning. Errors in the protocol, which can only be detected during execution, are detected and corrected during commissioning. This will substantially reduce the number of protocol amendments and test failures encountered. Modification of approved Qualification protocols must happen under full QA change control and approval, and is therefore time consuming. By adopting this approach, qualification time will be reduced.
• Tests that have been executed during commissioning (the results of which have been described and documented according to GMP and which have not been influenced by changes) do not have to be repeated during qualification. By using the same test protocol during commissioning and qualification there is assurance that acceptance criteria and executing procedures are identical so that the leveraging approach is of high quality.
• If changes after the commissioning of a system are kept to a minimum, a paper audit of the commissioning results is all that is required during the subsequent qualification step. Qualification tests only need to be executed, if changes are made after commissioning.
• As the commissioning exercise of this approach is more extensive than what is done traditionally, hidden problems are more likely to be identified during the commissioning phase so that little failed tests should occur in the formal qualification phase.

The challenge is to determine and agree the level of leveraging from commissioning in to qualification.

Click here to view the Leverage Diagram

We also provide contract qualification services including: Standard Operating Procedures (SOPs)

Click here to view the Standalone Qualification Diagram

Many of our specialists and consultants have experience within the pharmaceutical manufacturing industry and consequently have a good in-depth knowledge and experience in working in a GMP environment. We are able to prepare SOPs for operation, maintenance and calibration of equipment and for many other aspects of the quality system. In some cases clients have asked us to prepare SOPs for processing operations, particularly for advance technologies.

Qualification Protocols

We have experience of many different technologies and have prepared and executed protocols for Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Cleaning Validation, Process Qualification and Analytical Method Validation, for many of these technologies. We have an extensive library of protocols, which can be tailored to your needs.For commonly used equipment we have protocols which can be quickly retrieved and modified. Our experience saves you time and cost.

Summary Reports

Summary reports are prepared for all protocols executed. These are intended to provide a concise summary document to assist in presenting validation data to regulatory Investigators and assessors. Summary reports are used to present a summary of the data obtained, to interpret the results and to conclude whether the objectives of the study were met. They may contain recommendations for additional process controls or changes to operating procedures. They may also contain recommendations for calibration, re-validation, additional training and change control.

DQ, IQ, OQ, PQ Execution

Our specialists have extensive experience of protocol execution. They all operate to a standard set of internal SPGL SOPs and use common test equipment.

Clients may either elect to use our SOPs or may wish to use their ow. We can undertake all execution work or train your own operators and supervise execution activities. The Choice is yours.

Click here to view the Integrated E,P, C, V SI Timeline Diagram

Project Management

The Validation & GMP Compliance Group is distinct from many other validation contractors in that we offer highly qualified project managers, with a variety of project experience. All our project managers have relevant experience for the projects they manage. We also have an impressive list of clients and successful projects, which range from small projects involving a single process or filling line through to large integrated engineering, design and validation projects involving major new facilities. On our integrated projects there is always a validation project manager independent of the engineering project, to ensure that validation needs are met and cGMP compliance is maintained throughout.

Click here to view the Validation Project Management Diagram