情報シートプロセス性能認定(PPQ):デジタル・プロセス・システムの早期導入で、主導権を握る

プロセス性能適格性評価(PPQ):デジタル・プロセス・システムの早期導入で主導権を握る

情報シート

Software brings value to manufacturing process performance qualification PDとマニュファクチャリングのギャップを埋めることによって。

プロセス性能認定用PIMS

について 医薬品開発 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 to ensure quality at every stage. For cell and gene therapy modalities, the imperative for precision medicine quality control extends to patient data and the raw materials supply chain (e.g., AVV viral vectors).

残念なことに バイオファーマ industry do not consider technology until they are overwhelmed monitoring the manufacturing process at scale 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.

Digital best practices include early implementation of a centralized digital “データバックボーン” across the BioPharma lifecycle. When building your process definition, this can save significant time and reduce risk down the line when gathering and verifying critical quality 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 and quality analysis and PPQ later.

Early evaluation and 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: scientific discovery, Process Design, PPQ and Continued Process Verification (CPV). 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, delivering best practices for product quality, process monitoring and batch analysis:

データ継続性の促進

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.

矛盾を避ける

A process data management 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 with a single source of truth and robust quality analysis capabilities.

プロセスの複製

一貫性を確保するために不可欠なのは、設計通りのプロセスが再現可能であることを確認することである。PPQは、PDにおける小規模なプロセス開発と、大規模なcGMPの間の足がかりと考えてください。

Process performance qualification shows that you are in control of the process via continuous process evaluation and analysis that show all critical process parameters and quality attributes at a 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 within your own business units and across manufacturing partners.

A cloud-based process data management solution like IDBS PIMS は、PD(前臨床)から臨床、商業生産に至るまで、重要なプロセスデータを管理するための単一のデジタル「ライブラリ」を提供します。統合されたワークフローは、各段階でのデータの取得と検証を確実にします。PIMSは、より少ない実行回数で済むような逸脱を回避し、コスト削減と迅速な市場投入を支援します。

“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

スケールアップと技術移転の成功

If you are relying on spreadsheets and paper records to monitor the manufacturing 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 IDBS PIMS, speeds scale-up and tech transfer as you move through stages:

  • At the PD stage, IDBS 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, 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 process stage, IDBS 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 data and understanding are easily shared.

概要

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. Manufacturing process Performance Qualification enables you to establish that process control, by tracking process data as process development and understanding are essential. Simply put, IDBS PIMS improves your chances of successful PPQ for both internal and external teams working in geographically diverse manufacturing sites.

IDBS PIMS process information management system is a centralized, single source of truth for your critical manufacturing process data designed specifically for the BioPharma lifecycle and large molecule pharmaceutical industry. Implementation of the cloud-based 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. IDBS PIMS provides data transparency and embedded analytics to both expedite and reduce the risk of your scale-up and tech transfer with continued process verification support built in.

 

デジタル・プロセスを早期に導入すべき理由については、こちらをご覧ください。

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F.A.I.R.であることの緊急性

なぜ科学者はデータを最大限に活用しないのか?この記事では、データ活用を阻む要因について議論する...