Qualification / Validation


Our consultants have extensive experience of conducting risk assessments and criticality analysis for process facilities. Our team would typically carryout risk assessments and criticality analysis during the design phase of the project, in order to classify systems into ‘critical’ and ‘non-critical’ impact systems. This is significant, as critical systems or high-risk systems will require a higher level of documentation, field inspections and testing. 


User Requirement Specifications (URS) are critical documents as their primary purpose is to document, at a high level, what users need from facilities, systems or utilities. They are also the basis for design, procurement, commissioning, qualification & validation activities.  

Honed in the highly demanding world of regulated industries and products, our engineers and scientist have considerable experience in supporting our customers with the preparation of URS’s for a variety of industries.


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.


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 own. We can undertake all execution work or train your own operators and supervise execution activities. The choice is yours.


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


Our group contains a number of consultants and specialists with manufacturing, QA and development experience working in major pharmaceutical manufacturing companies. Using this experience, we have been able to assist clients in developing validation plans and rationales for cleaning validation projects.

Our consultants have particular expertise in the field of aseptic processing, antibiotic processing, antibiotic powders, fermentation and biotechnology processes, tablets and capsules and highly automated processes. Our portfolio of projects ranges from products in the phases of clinical development, through new product start-ups, to modification and reengineering of existing processes.


In order to conduct process validation, it is necessary to ensure that all components of the facility validation are complete, i.e. utilities, equipment, environment and automation. The combination of these with the appropriate material and use of trained personnel will result in product which is fit for purpose. 

Our experienced engineers and scientists are able to assist clients in developing plans and rationales for process validation projects.


SPGL provides consultancy services on both a technical and regulatory basis for automation and IT projects in a range of market sectors. Our risk-based approach to computer system validation is based on best industry practice and guides such as Good Automated Manufacturing Practice (GAMP). Areas of expertise include:

Manufacturing Systems

  • PLC
  • DCS/Delta V
  • MES

IT Systems

  • EQMS: Electronic Quality Management Systems
  • EDMS: Electronic Document Management Systems
  • ERP
  • Clinical Trails: TMF, CTMS, EDC
  • Pharmacovigilance: Safety Systems


Retrospective validation is used for facilities, processes and process controls in operation use that have not undergone a formally documented validation process. Validation of these facilities, processes and process controls is possible using historical data to provide the necessary documentary evidence that the process is doing what it is believed to do.

At SPGL, we have developed a risk-based approach to retrospective validation, based on best industry practices and guides such as the ISPE.

Our experienced engineers/specialists have extensive retrospective validation experience and are able to assist clients in developing plans, procedures and reports as well as carrying our risk assessments.


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

We have learned from experience that significant cost and schedule savings can be realized 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 field quality is to apply regulatory compliance principles to construction activities to ensure a smooth transition into commissioning. Our field quality program 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.


Our Verification Approach is based on the ASTM E2500 standard and it applies the concepts and principles introduced in the FDA initiative, Pharmaceutical cGMPs for the 21st century. It’s a ‘Science and Risk-Based Approach’ that focusses on the ‘critical aspects of manufacturing systems’.

By applying these principles from the design phase there has been a paradigm shift from qualification/validation to ‘quality by design’.

GEP (Good Engineering Practice) and SME (Subject Matter Expert) knowledge underpin the methodology and the use of vendor documentation is an integral part of the approach. The approach can be applied to small and large projects.

GMP Services


Our consultants perform frequent GMP audits and gap analyses. These may be design and engineering audits relating to a particular facility or they may be audits of validation activities, or cGMP audits of an existing operation or mock inspections to all regulatory standards. Our audits can include laboratories, manufacturing procedures, quality assurance release, compliance and recall procedures, purchasing and vendor approval procedures and computer systems.


Success in validation depends upon careful planning at all levels. Our services frequently include the preparation of validation plans ranging from plans for a single processing line to site-wide Validation Master Plans (VMP).

The objectives of the plans are as follows:

  • Define scope and responsibilities for the validation activities within the project or the site
  • Identify the GMP regulatory requirements
  • Identify and plan the resource requirements
  • Define the common standards and specifications which apply across the entire project or site
  • Define the applicable procedures and general acceptance criteria for all protocols, not necessarily the system specific criteria

The Validation Master Plan also serves as a management tool for introduction of the project to regulatory authorities, senior management, auditors and other third parties as needed. It is the ‘map’ for the validation project.


Our consultants have conducted many mock inspections to prepare companies for preapproval or routine GMP inspections. The scope of these has ranged from inspections of specific operations through to full site GMP audits. Inspections can be undertaken against any international GMP standards and findings are reported in a constructive manner and options for remedial action are presented.


We often find that clients have a specific problem or question that requires a regulatory interpretation such as a practical interpretation of a particular guideline. Our consultants can bring their own wide experience to resolve such issues. It is often the case that other clients have had similar problems and a resolution has been found which can be applied to another facility.

Sometime clients wish to get comments directly from the regulatory authorities without being identified. In these instances our consultants can act on behalf of the client and maintain the client confidentiality


In today’s fast-moving world, companies are transferring products and processes from one site to another, often facing limitations on time, resources, and regulatory expectations. Transfers can be complicated, and many companies don’t have a comprehensive plan, standard operating procedures or guidelines in place to effectively conduct the technology transfer.

At SPGL our team of multi-functional life science consultants have proven success in managing product and process transfers for our clients. Let our experts demonstrate how to transfer your product or process in the most efficient manner possible, ensuring compliance along the entire way. Areas of expertise include:

  • Process familiarization & Characterisation
  • Technology Transfer Plans
  • URS, Risk Assessments & GAP Analysis
  • Qualification (DQ, IQ, OQ, PQ), Process & Cleaning Validation
  • Computer Systems Validation
  • Methods Validation
  • Regulatory Audits
  • Preparation for Regulatory Inspections
  • Regulatory Filing
  • Technical/Feasibility Batch Studies
  • Data Gathering & Data Verification / Integrity


Our consultants have the capability to provide a wide range of in-house training courses using a combination of formal presentations, workshops and discussion topics, or they can consist of equipment demonstrations or one-to-one practical training in validation topics.

All our training is accompanied by relevant course material and certificates. If required, our consultants can carry out formal assessments of the training provided. The training courses offered include general GMP and technology related topics.


Deviation Management/CAPA is a vital process used in the biopharmaceutical manufacturing world to prevent ‘new’ problems from arising and ‘known’ problems from re-occurring. Any departure from a normal, agreed or validated process used for the manufacture of drug products could potentially compromise patient safety and ultimately lead to death.

At SPGL we have a number of experts with a wealth of QA/QC knowledge and hands-on experience. Our consultants have supported numerous clients in developing and executing Deviation Management/CAPA plans and strategies.


Batch Records should ideally be designed in such a way that it captures all the typical steps of a manufacturing process. They are crucial documents, especially as they are often the only evidence that remains after a batch has been produced, to demonstrate that it was manufactured according to procedural and regulatory requirements.

Perfected in the highly demanding world of regulated industries and products, our engineers & scientist have considerable experience in designing & reviewing Batch Records for a variety of manufacturing processes.


In a modern fast-moving world many sectors, including the life sciences industry has started to rely on computer and automated systems to a great extent, whether in terms of manufacturing or laboratory release testing. Consequently, there is a renewed focus on the accuracy and consistency of data over its entire lifecycle.

For several years, the FDA and other global regulatory bodies have emphasised the importance of accurate and reliable data in assuring drug safety and quality. However, in tandem with increased digital sophistication and the role of global manufacturing partners, data integrity violations have been on the rise.

Our group contains a number of data integrity experts with manufacturing, QA and IT experience working in major pharmaceutical manufacturing companies. Using this experience, we have been able to assist clients in developing data integrity policies, plans & procedures as well as help carryout audits and risk assessments.


Implementing serialisation systems in accordance with the latest regulatory guidelines can be a dauting and complex task, especially when it involves specialist machinery, IT systems and a multitude of departments such production, engineering, automation, IT, validation, QA, warehousing, regulatory and finance.

At SPGL we have a number of experts with a wealth of serialisation knowledge and hands-on experience. Our consultants have supported numerous clients in developing sterilisation strategies, plans and polices as well as hands-on project execution.


Many of our consultants and specialists have experience within the biopharmaceutical manufacturing industry and therefore have a good in-depth knowledge and experience of 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.


Six Sigma, a systematic approach to measure and improve operational performance through the use of analytical and statistical techniques. Lean Management, on the other hand, is a set of methods aimed at generating added value for the process by eliminating various forms of waste.

Our group contains a number of Lean and Six Sigma experts with a wealth of knowledge and hands-on experience. Our experts have supported numerous clients in improving their manufacturing processes by eliminating waste and reducing process variability. We are also able to provide Lean and Six Sigma training onsite or in a classroom setting.