Process Performance Qualification (PPQ): Early adoption of digital process systems puts you in control

Software brings value to Process Performance Qualification activities by bridging the gap between PD and manufacturing.

PIMS for Process Performance Qualification

The drug development lifecycle is vital to delivering safe and effective drugs. Key to this success is adopting technology as early in the lifecycle as possible and using that software to monitor process data from early-stage development through commercial manufacturing.

Unfortunately, many in the BioPharma industry do not consider technology until they are overwhelmed monitoring processes via paper and spreadsheets, or they experience hardship in manually preparing business and regulatory reporting for FDA submissions – which tend to occur in Phases II or III of a product’s lifecycle.

Early implementation of a centralized digital “data backbone” when building your process definition can save significant time and reduce risk down the line when gathering and verifying critical data for process monitoring, understanding and optimization. Do not wait until the process definition is completed. The earlier you start capturing process data, the better insight and knowledge you will have to make decisions throughout process development.

Early adoption of digital technology, such as process information management systems (PIMS), establishes that data backbone and provides foundational knowledge throughout a drug’s lifecycle events: Design, Process Performance Qualification (PPQ) and Continued Process Verification. Process Performance Qualification, the focus of this technical brief, establishes scientific evidence that a drug’s lifecycle development process is capable of consistently delivering quality product from early stages through commercial manufacturing. A digital system like PIMS will reap the following benefits during Process Performance Qualification:

Facilitate data continuity

When PD and manufacturing teams know exactly what happened during benchtop activities and process characterization, data continuity is ensured. Work performed at benchtop – the rationale behind the process, including changes, improvements and information about what did or did not work – can be fed into a system like PIMS. Any tweaking prior to process definition completion will reside in the PIMS audit trail, so you will know how and why that definition was achieved.

Avoid discrepancies

A system like PIMS avoids missing discrepancies that can occur with paper and spreadsheets, which can cause costly loss of material and slow time to market. PIMS enables you to easily and confidently track and identify differential values that exist between small-scale and large-scale processes. This will enable you to analyze and understand why these discrepancies are occurring, identifying what works well and what does not.

Replicating processes

Essential to ensuring that consistency is confirming that the process, as designed, is reproducible. Think of PPQ as a stepping stone between process development at a small scale in PD and cGMP at a large scale.

Process Performance Qualification shows that you are in control of the process, monitoring and showing all critical process parameters and quality attributes at small scale are replicated and obtained at the larger scale. The more control you have over the process, the higher the probability of successfully executing your batch runs.

A cloud-based solution like Skyland PIMS provides a single digital “library” to manage critical process data from PD (preclinical) through clinical and commercial manufacturing. Integrated workflows ensure data is captured and validated at each phase. PIMS helps avoid deviations that equate to needing to perform fewer runs, saving money and getting to market faster.

“A successful Process Performance Qualification will confirm the process design and demonstrate that the commercial manufacturing process performs as expected.” – FDA’s 2011 Process Validation: General Principles and Practices Guidance

Successful scale-up & tech transfer

If you are relying on spreadsheets and paper records to monitor the process parameters of these runs, there is a good chance you will miss something along the way as you move to scale up from small-scale manufacturing to pilot scale and eventually cGMP manufacturing. Deploying a cloud-based, 21 CFR Part 11-compliant, centralized data hub, such as Skyland PIMS, speeds scale-up and tech transfer as you move through stages:

• At the PD stage, Skyland PIMS reduces data entry, tracks protocol changes, compares experimental results, and provides transparency to share protocols and reports across internal and external teams, sites and partners.
• As you move into clinical manufacturing, Skyland PIMS establishes and monitors critical process parameters, ensures CPV, monitors multi-site batch production, identifies deviations for faster corrective action, provides visibility of process differences among sites, creates a full audit trail and maps batch-related data.
• Finally, at the commercial manufacturing stage, Skyland PIMS creates a centralized data repository for all critical batch-related data, contextualizes information from siloed data sources and enables vital collaboration across Sponsor-CDMO/CMO networks. At each milestone during scale-up and tech transfer, process understanding is easily shared.

Summary

The quality of your product is intrinsically linked to your control over the manufacturing process. Without process control, bad product quality is just a matter of time. Process Performance Qualification enables you to establish that process control, by tracking process understanding as process development is essential. Simply put, PIMS improves your chances of successful PPQ.

Skyland PIMS process information management system is a centralized, single source of truth for your critical manufacturing process data designed specifically for BioPharma companies. The software bridges the data gap between preclinical PD and clinical and commercial-stage manufacturing to ensure that processes are controlled throughout a product’s lifecycle. Skyland PIMS provides data transparency and embedded analytics to both expedite and reduce the risk of your scale-up and tech transfer.

 

Find out more about why you should adopt digital processes early.