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:
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:
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.