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What are the most common pitfalls and mistakes to avoid in drug product specification development?

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Drug product specification development is a crucial step in ensuring the quality, safety, and efficacy of pharmaceutical products. However, it can also be a source of errors and deviations if not done properly. In this article, you will learn about some of the most common pitfalls and mistakes to avoid in drug product specification development, and how to apply good manufacturing practice (GMP) principles to prevent them.

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1 Define clear and realistic specifications

One of the first challenges in drug product specification development is to define clear and realistic specifications that reflect the intended use, performance, and stability of the product. Specifications should be based on sound scientific rationale, regulatory requirements, and relevant data from development and validation studies. They should also be consistent with the product's quality attributes, critical quality attributes, and control strategy. Avoid setting specifications that are too broad, too narrow, or irrelevant to the product's quality.

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George Trager
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When setting specification limits, ensure that the limit aligns with contemporary regulatory expectations and process capability and that they align with the expected dosage and route of administration of the product. Setting a tighter specification than required may result in lot failures for products that would actually be suitable for the intended use of the product.

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Jeffrey C. Mocny, Ph.D.

Executive Leader in Product Strategy | Regulatory Strategy | Quality Management | Product Development
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Great suggestions by all and germane. I suggest that the reason for the need to update specs originates with inadequate characterization of the subject material, or resulting from a method that wasn’t properly deemed fit for purpose, resulting in aberrations in data points. I propose that analytical methods should follow ICH Q14 principles to minimize this. Additionally, specs were set inappropriately for the subject material that is not fit for the stage of development- often times there is temptation to assign a spec pertinent to later stage development in the early development stages on a false sense of confidence in understanding the material and/process. A simple report results is acceptable.

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Irina Perdivara

Senior QA Manager at FUJIFILM Diosynth Biotechnologies
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1) Not having a robust assay for the CQA and the process, is by far the most dangerous pitfall. Not only could the CQA be over or under-estimated, but it could also result in inability to understand the process and critical process steps. 2) Setting a spec with data obtained at a different lab then where routine testing is intended to occur (e.g. tech transfer situations, due to differences in instruments, techniques, etc.) 3) Not understanding the process and making frequent process changes w/o understanding process/product impact. 4) Not understanding the relationship between the attribute, and its impact on patient safety and efficacy - i.e. need to ensure the attribute is indeed a Critical one before being considered for spec setting.

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Stephanie Smith

Process Engineering Senior Manager: MSAT Drug Product
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Make sure that ranges are established with equipment tolerances and calibrations in mind. Oftentimes, process specifications are established based on successful development runs without testing the true limitations of "success" and "failure". Without that understanding, a process can be at risk of "hidden" variability as equipment naturally drifts within acceptable tolerance limits.

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Mark Weiss
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It is important to understand the difference in specifications for release (EMA) and expiry (US & EMA). Tighter release specifications ensure the product will meet the regulatory/shelf-life specification. All other data should support the quality criteria.

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2 Follow change control procedures

Another common pitfall in drug product specification development is to make changes to the specifications without following the appropriate change control procedures. Change control is a systematic process that ensures that any changes to the specifications are justified, documented, reviewed, approved, and communicated to all relevant parties. Change control also helps to assess the impact of the changes on the product's quality, safety, efficacy, and regulatory compliance. Avoid making changes to the specifications without a valid reason, without sufficient data, or without proper authorization.

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3 Monitor and review specifications

A third common mistake in drug product specification development is to neglect the monitoring and review of the specifications over time. Specifications are not static, but dynamic, and they may need to be updated or revised based on new information, feedback, or experience. Monitoring and review of the specifications are essential to verify their suitability, effectiveness, and robustness, and to identify any gaps, issues, or opportunities for improvement. Avoid using outdated, obsolete, or incorrect specifications, or ignoring the signals of potential problems or deviations.

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4 Align with other specifications

A fourth common pitfall in drug product specification development is to overlook the alignment of the specifications with other specifications in the product lifecycle. Specifications are not isolated, but interrelated, and they should be consistent and compatible with the specifications of the raw materials, intermediates, active pharmaceutical ingredients, packaging materials, and finished products. Alignment of the specifications helps to ensure the traceability, continuity, and integrity of the product quality throughout the supply chain. Avoid creating discrepancies, conflicts, or gaps between the specifications of different stages or components of the product.

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5 Communicate and collaborate with stakeholders

A fifth common mistake in drug product specification development is to fail to communicate and collaborate with the relevant stakeholders involved in the product lifecycle. Stakeholders include the internal and external parties that have a role or interest in the product quality, such as the development, manufacturing, quality, regulatory, clinical, and marketing teams, as well as the suppliers, customers, and authorities. Communication and collaboration with the stakeholders help to ensure the alignment of the expectations, requirements, and feedback regarding the product specifications. Avoid working in silos, withholding information, or ignoring the input or concerns of the stakeholders.

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6 Follow GMP guidelines and best practices

A sixth common pitfall in drug product specification development is to disregard the GMP guidelines and best practices that apply to the product. GMP is a set of standards and principles that ensure the quality, safety, and efficacy of pharmaceutical products by controlling the design, development, manufacturing, testing, distribution, and storage of the products. GMP also provides guidance and recommendations on how to develop, implement, and maintain effective specifications for the products. Avoid violating, deviating from, or ignoring the GMP guidelines and best practices that govern the product specifications.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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What are the most common pitfalls and mistakes to avoid in drug product specification development?

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1 Define clear and realistic specifications

2 Follow change control procedures

3 Monitor and review specifications

4 Align with other specifications

5 Communicate and collaborate with stakeholders

6 Follow GMP guidelines and best practices

7 Here’s what else to consider

GMP

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