How do you validate manufacturing process changes?

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Manufacturing process changes are inevitable in any industry, but they can also pose risks to product quality, safety, and compliance. That's why you need to validate them before implementing them in your production line. Validation is the evidence-based confirmation that a process change meets the predefined specifications and requirements for its intended use. In this article, you'll learn how to validate manufacturing process changes following the Good Manufacturing Practice (GMP) principles and guidelines.

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Marta Rodríguez Vélez

★ Biopharma ★ Quality & Regulatory Compliance ★ GXP ★ Top Voice: Good Manufacturing Practices ★ Top Voice: Quality…
Mohammad Naiem Salem

Pharmaceutical Industry Development Unit Manager| PMP| GMDP Lead Inspector| Quality Risk Management

4 个答复

1 What is a process change?

Process changes refer to any modifications or adjustments to the existing manufacturing process, equipment, materials, methods, or environment that can affect the product characteristics or performance. These changes can be planned or unplanned, minor or major, temporary or permanent. Examples include switching suppliers for raw materials or components, replacing or upgrading a machine or tool, altering the process parameters or settings, introducing a new test or measurement method, and adding or removing a process step or stage.

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Mohammad Naiem Salem

Pharmaceutical Industry Development Unit Manager| PMP| GMDP Lead Inspector| Quality Risk Management
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Firstly my recommendation is to be consistent with the basic requirements of ICH Q10, an effective change management system supports the principles of ICHQ 12 guideline as: 1. Captures stimuli for change, including those that can improve product performance or process robustness; 2. Ensures full understanding of the scope of the change and its implications for all aspects of the process and control strategy including the impact on ECs and aspects that are not ECs in affected marketing authorisations; 3. Leverages existing process performance and product quality knowledge; 4. Requires science-based risk management and risk categorisation of the intended change; considers the potential impact if the intended change is not implemented;

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Marta Rodríguez Vélez

★ Biopharma ★ Quality & Regulatory Compliance ★ GXP ★ Top Voice: Good Manufacturing Practices ★ Top Voice: Quality Management
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In the biopharma industry, change management is critical due to the complex nature of manufacturing processes and the stringent regulatory requirements. When changes are made to the manufacturing process, they must be validated to ensure that product quality, safety, and efficacy are maintained. A robust Change Control System is essential for managing any modifications. Every proposed change must be documented, reviewed, and approved through a formal change control process. This involves defining the scope, rationale, and impact of the change on the product, process, and regulatory commitments.

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2 Why do you need to validate process changes?

Validation of process changes is essential to ensure that quality, safety, and efficacy of products are not compromised. Through validation, you can identify and control potential sources of variation or error in your process, demonstrate that your process change meets regulatory standards and customer expectations, reduce the risk of defects, deviations, or failures in your products, and minimize the waste, rework, or recall costs associated with nonconforming products. Additionally, it helps maintain the consistency and reliability of your process performance and product outcomes.

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Marta Rodríguez Vélez

★ Biopharma ★ Quality & Regulatory Compliance ★ GXP ★ Top Voice: Good Manufacturing Practices ★ Top Voice: Quality Management
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Validating process changes in biopharmaceutical manufacturing is essential to ensure the safety, quality, and efficacy of the final product, to ensure patient safety, and to comply with regulatory requirements. Any change in the manufacturing process could potentially impact the critical quality attributes (CQAs) of the product, such as its potency, purity, or stability, so it could impact on patients' safety. Validation helps identify and mitigate potential risks, and ensures that CQAs remain within acceptable limits, maintaining consistent product quality. Above all, validation is mandatory from a regulatory perspective. Failing to validate changes could compromise the GMP license, lead to product recalls and even production halts.

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3 How do you plan and document process changes?

Prior to validating a process change, it is essential to plan and document it properly. This includes defining the scope, objective, and rationale of the process change, assessing the impact and risk on product quality and regulatory compliance, establishing the acceptance criteria and specifications, designing the validation protocol and strategy, and obtaining approval and authorization from relevant stakeholders. All these steps should be documented in a change control form or record that details the justification of the process change, validation plan and results, and implementation and verification actions.

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4 How do you execute and evaluate process changes?

Executing and evaluating a process change requires following the validation protocol and strategy designed in the previous step. This typically involves performing the process change under controlled and representative conditions, collecting and analyzing data and evidence, comparing it with the acceptance criteria and specifications, determining the validity and effectiveness of the process change, and reporting and documenting the validation findings and conclusions. All of these steps should be documented in a validation report or summary that outlines the validation activities and outcomes, any deviations or issues encountered, and corrective or preventive actions taken.

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5 How do you implement and verify process changes?

Once you validate a process change, you must implement and verify it in your routine production. This involves communicating and training the relevant personnel on the process change, updating and revising the standard operating procedures, work instructions, and records related to it, monitoring and controlling the process during production, verifying that it meets the predefined specifications and requirements in production, and reviewing and auditing the process change periodically for continuous improvement. All these steps should be documented in a change implementation and verification form or record that tracks the status, progress, monitoring results, verification results, feedback, and improvement actions.

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