I am willing to sacrifice quality for an inexpensive solution. Said no pharma client ever.
Quality is non-negotiable when it comes to pharma process engineering, especially in the case of sterile applications, so the inevitable cost savings must be found elsewhere.
One of the critical ways a customer can save costs is by opting for a diligent process partner. Communication errors and oversight are often the root cause of mid-project challenges that lead to inevitable and expensive delays. The right process partner will ask the right questions at every step of the scoping process. Questions that drill down to the teeniest details to ensure they are in sync and as informed as you at a granular level.
Another way to optimise costs is to closely examine every stage of the process to improve and enhance operations. With a deeper understanding of your current process, the right partner can help you dovetail new initiatives so there is symmetry with relevant recommendations for your processes and equipment and spares.
The right partner will have a robust review process with clear milestones and transparent communications at every step of the delivery lifecycle that can sound the alarm on potentially expensive challenges in the early stages. A thorough review process would include
- a timeline based on scope, specs and deliverables
- an execution plan
- an estimate of resources
- a risk assessment
- milestone check-ins
An often overlooked method to optimise costs is through automation which quickly pays for itself by improving efficiency and safety.
Most projects have some level of automation, where accuracy and repeatability are critical. This is a major benefit for the pharma industry as it removes personnel from certain situations, keeping them safe from hazardous chemicals.
When choosing a solution provider, it helps if they have in-house automation capability. At TSA, we’ve built a lean core team to support customers with design, process quality and automation. Our subject matter experts all have client-side experience, allowing them to have peer-level interactions with customers. Having been on the manufacturing side, they have firsthand experience with regulatory compliances and potential bottlenecks, which significantly informs the scope, design, and delivery of our water and process offerings.
They also have a deep and broad knowledge of GAMP 5 regulatory and compliance norms. GAMP5 guidance is aligned to the ICH Q9 guidance, and both suggest the use of risk assessment as the key input to deciding the extent and effort for validation. This allows us to dovetail automation into our scope regarding qualification and audits, resulting in minimum changes onsite.
If the project scope and deliverables remain unchanged, our teams can support process qualification LVP, SVP, BFS and FFS within the 15-day cycle with a 100% success rate.
While a team of subject matter experts does not make us more expensive – it allows us to offer cost optimisations through an accurate understanding and delivery of customer objectives.
Process quality is ensured per the latest international guidelines and compliances. All materials are fabricated per ASME BTE, Section 8, Division 1, with inbuilt QAP/SOP methods for conducting quality inspection and testing.
Another aspect that makes TSA’s offering unique is that our service support and onsite engineering teams also comprise subject matter experts to ensure zero chance of failure during commissioning and validation.
