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Last updated on 2024年6月2日

How do you determine the acceptable residue limits for different types of products and equipment?

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Cleaning validation is a crucial process to ensure the quality and safety of pharmaceutical products. It involves verifying that the equipment and facilities used to manufacture different products are free of any unacceptable residues that could compromise the efficacy, purity, or stability of the next product. But how do you determine what constitutes an acceptable residue limit for different types of products and equipment? In this article, we will explore some of the key factors and methods that influence this decision.

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1 Regulatory requirements

One of the first factors to consider when determining the acceptable residue limits is the regulatory requirements of the market where the product is intended to be sold. Different regions and authorities may have different standards and guidelines for cleaning validation, such as the FDA, EMA, PIC/S, WHO, or ICH. These may specify the general principles, criteria, and methods for establishing and demonstrating the adequacy of cleaning validation, as well as the acceptable limits for various types of residues, such as active pharmaceutical ingredients (APIs), excipients, detergents, bioburden, or endotoxins. Therefore, it is important to review and comply with the relevant regulations and expectations for each product and market.

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Ram Kouda. PhD, MBA, LSSMBB

||Strategy II Innovation||Transformation ||Leadership II Engineering/Scientific||Operations||Data
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The starting sentence in the paragraph can mislead, the cleaning acceptance limit is not just about meeting the regulatory requirements, it has to be based on toxicology(patient safety),and as Andrew mentioned it should be scientifically justifiable.

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Reham Ahmed

Quality Assurance Manager at Vitabiotics /TOT /Lead Auditor IRCA certified ISO 9001, 14001 and 45001,/ IMS consultant
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From the preliminary requirement of the pharmaceutical industries, the 3 main pillar that any product must have (Quality, safety and efficacy) One of the Aspects of safety is prevent potential contamination or cross contamination that could be generated during manufacturing, so the cleaning procedure design and validation is originated to ensure that the cleaning procedure is effectively and consistently reduce product and cleaning agent residues from product contact surfaces to acceptable limits And the strategy to calculate these acceptance limits depend on the regulatory requirement, may vary in some points but all based on the same concepts and accepting criteria (physically , chemically and microbiologically )

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Julie Z.

全球业务总监|12年业务经验? 我帮助进口商、分销商和品牌在 #工业真空吸尘器领域获得更多市场份额
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Acceptable residue limits are determined by regulatory guidelines, risk assessments, industry standards, specific product usage, historical data, and continuous monitoring. Consultation with experts and thorough testing also play crucial roles in ensuring compliance and safety.

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2 Risk assessment

Another factor to consider when determining the acceptable residue limits is the risk assessment of the potential impact of the residues on the next product. This involves identifying and evaluating the sources and types of residues, the characteristics and sensitivity of the next product, the cleaning process and frequency, and the sampling and analytical methods. Based on these factors, a risk matrix can be developed to rank the potential hazards and criticality of the residues, and to establish the appropriate limits and acceptance criteria. A risk-based approach can help to focus the cleaning validation efforts on the most significant and relevant risks, and to justify the rationale and scientific basis for the limits.

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Reham Ahmed

Quality Assurance Manager at Vitabiotics /TOT /Lead Auditor IRCA certified ISO 9001, 14001 and 45001,/ IMS consultant
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Determine the acceptance Limit by that the cleaning procedure will be challenged, according to validation Policy I-individually, each product that has its own acceptance limit chemically for API/detergent/ solvent used in the cleaning procedure II-Grouping/bracketing Method, which including grouping all products that share the same equipment line/cleaning procedure and choose one to used in calculation of the acceptance Limit, this method involves a risk assessment for: 1-Solubility 2-Cleanability 3-Toxicity 4-Potency, a risk matrix for all products to choose the worst case (product A) both cases need to choose the next product (Product B), which hypothetically the product that will be affected with the residues from the previous product

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3 Calculation methods

A third factor to consider when determining the acceptable residue limits is the calculation methods that are used to derive the limits from the risk assessment and regulatory requirements. There are several methods that are commonly used in the industry, such as the maximum allowable carryover (MAC), the 10 ppm criterion, the no-observed-adverse-effect level (NOAEL), or the permitted daily exposure (PDE). Each method has its own assumptions, advantages, and limitations, and may result in different limits for the same residue and product. Therefore, it is important to understand the principles and applicability of each method, and to select the most appropriate and conservative one for each situation.

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Dean Calhoun, CIH

Entrepreneur ?Founder/CEO Affygility Solutions. Product Owner ??Keynote Speaker ?? Traveler ?? Certified Industrial Hygienist????Fast Company Executive Board Member, Founder University Cohort 4
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The 10 ppm or the 1/1000th approaches for determining acceptable residue limits should no longer be used. These approaches have been replace the health-based exposure limits (HBELs), also know as PDE or ADE. These values should be determined by a qualified toxicologist and thoroughly documented.

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Ben Lucas

Major Accounts Manager at Inland Technology Inc
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There are plenty of non-Volatile Residue (NBR) test methods available to be performed by independent laboratories for a wide variety of materials in oder to understand the residue position they hold. The American Society of Testing & Material standards (ASTM) has well established engineering procedures for testing chemicals and similar compounds to industry accepted thresholds to give residue insight. In my business, substitution chemistry for industry, we use some of these labs for validation of our materials for use in critical processes that our clients need.

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4 Product grouping

A fourth factor to consider when determining the acceptable residue limits is the product grouping strategy that is adopted to simplify and optimize the cleaning validation process. Product grouping involves classifying the products into different groups or families based on their similarities in terms of composition, potency, toxicity, solubility, or therapeutic category. By doing so, the cleaning validation can be performed for the worst-case product in each group, and the limits and acceptance criteria can be applied to the other products in the same group. This can reduce the number of cleaning validation studies and samples required, and increase the efficiency and flexibility of the cleaning validation process.

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5 Equipment grouping

A fifth factor to consider when determining the acceptable residue limits is the equipment grouping strategy that is adopted to simplify and optimize the cleaning validation process. Equipment grouping involves classifying the equipment into different groups or trains based on their similarities in terms of design, function, size, material, or usage. By doing so, the cleaning validation can be performed for the worst-case equipment in each group, and the limits and acceptance criteria can be applied to the other equipment in the same group. This can also reduce the number of cleaning validation studies and samples required, and increase the efficiency and flexibility of the cleaning validation process.

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6 Continuous improvement

A sixth factor to consider when determining the acceptable residue limits is the continuous improvement of the cleaning validation process. This involves monitoring and reviewing the performance and effectiveness of the cleaning validation process, as well as the changes and trends in the products, equipment, regulations, and methods. Based on the data and feedback collected, the cleaning validation process can be updated and improved to ensure that it remains adequate, robust, and compliant. This may include revising the limits and acceptance criteria, modifying the cleaning procedures and parameters, enhancing the sampling and analytical techniques, or implementing new technologies or tools.

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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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How do you determine the acceptable residue limits for different types of products and equipment?

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1 Regulatory requirements

2 Risk assessment

3 Calculation methods

4 Product grouping

5 Equipment grouping

6 Continuous improvement

7 Here’s what else to consider

Cleaning Validation

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