登录查看更多内容

How can you use stability indicating parameters for GMP products?

由人工智能和领英社区提供技术支持

If you work in the pharmaceutical, biotechnology, or medical device industry, you know how important it is to ensure the quality, safety, and efficacy of your products. One of the key aspects of quality control is stability testing, which evaluates how your products behave under various environmental conditions over time. Stability testing is not only required by regulatory agencies, but also helps you optimize your manufacturing processes, storage conditions, and shelf life. In this article, you will learn how to use stability indicating parameters for GMP products, and why they are essential for your quality management system.

此文章中的业界达人

由社区从 5 条内容中精选。了解更多

Khaled Bennouar

Quality Control Analyst @ Novo Nordisk | cGMP Compliance, Method Validation, Quality Assurance,Data integrity CSV &…
Sajid Latif

QHSE & Food Safety Manager@ Qatar Star Services | Certified Auditor, Certified HACCP Professional| BRCGS Qualified|…
Santosh Jagtap

General Manager at ASolution Pharmaceuticals Pvt. Ltd.

1 What are stability indicating parameters?

Stability indicating parameters are specific characteristics or attributes of your products that can be measured and monitored to assess their stability. These parameters may include physical, chemical, biological, or microbiological properties, such as appearance, pH, potency, purity, degradation products, sterility, or endotoxin levels. Stability indicating parameters should be selected based on the nature and composition of your products, the intended use and route of administration, and the potential degradation mechanisms and pathways. Ideally, stability indicating parameters should be sensitive, specific, accurate, precise, and reproducible.

添加您的观点

Khaled Bennouar

Quality Control Analyst @ Novo Nordisk | cGMP Compliance, Method Validation, Quality Assurance,Data integrity CSV & CSA, Change Control handling,SOP Management
举报内容
Stability indicating parameters are critical for ensuring the quality and safety of GMP (Good Manufacturing Practice) products. Stability indicating parameters are analytical methods that can detect changes in the composition or quality of a product over time, particularly during storage or transportation. These parameters are used to predict the shelf life of the product and to ensure that it remains safe and effective throughout its intended use.

已翻译

赞

2 How to design stability studies for GMP products?

Stability indicating parameters for GMP products must be designed and conducted according to relevant guidelines and standards, such as ICH Q1A for drug substances and products, ISO 11607 for medical device packaging, or USP <1112> for biologics. The stability studies should include a stability protocol that defines the objectives, scope, methods, acceptance criteria, and reporting of the study. Additionally, a representative sample of the product that reflects the final formulation, manufacturing process, and packaging is necessary. Furthermore, a set of storage conditions should simulate the expected or worst-case scenarios of temperature, humidity, light, and other factors that may affect the product stability. Moreover, a sampling plan should be implemented to specify the frequency, size, and location of the samples to be tested. Lastly, a testing plan should outline the analytical methods, equipment, and procedures to measure the stability indicating parameters. Data analysis and evaluation should compare the results with the acceptance criteria and determine the stability profile and shelf life of the product.

添加您的观点

Sajid Latif

QHSE & Food Safety Manager@ Qatar Star Services | Certified Auditor, Certified HACCP Professional| BRCGS Qualified| Certified IADT Trainer
举报内容
Stability indicating parameters are essential in the FMCGS and pharmaceutical industry, particularly for products manufactured under Good Manufacturing Practices (GMP). These parameters help ensure the quality, safety, and efficacy of FMCG and pharmaceutical products over their shelf life. 1. Identify Critical Quality Attributes 2. Develop Analytical Methods 3. Stress Testing 4. Degradation Analysis 5. Impurity Profiling 6. Establish Stability Indicating Parameters 7. Validation of SIP 8. Trend Analysis 9. Regulatory Submission 10. Monitoring and Improvement

已翻译

赞
Khaled Bennouar

Quality Control Analyst @ Novo Nordisk | cGMP Compliance, Method Validation, Quality Assurance,Data integrity CSV & CSA, Change Control handling,SOP Management
举报内容
In addition to the information provided, it is important to note that stability studies for GMP products should also take into account any potential interactions between the product and its container closure system. The container closure system can have a significant impact on the stability of the product, particularly for drugs that are sensitive to moisture, light, or oxygen. Furthermore, stability studies should also consider any potential degradation pathways of the product, including hydrolysis, oxidation, or photodegradation. Depending on the type of product, degradation pathways may be more pronounced under certain storage conditions, which should be taken into account when designing the stability study.

已翻译

赞

3 How to validate stability indicating methods for GMP products?

Before using stability indicating parameters for GMP products, you need to validate the analytical methods that you use to measure them. Validation is a process that proves that the methods are suitable for their intended purpose and can produce reliable and consistent results. This should be done in accordance with relevant guidelines and standards, such as ICH Q2 for validation of analytical procedures, ISO 17025 for general requirements for testing laboratories, or USP <1225> for validation of compendial methods. The validation should assess aspects such as specificity (ability to measure the parameter without interference), accuracy (closeness of measured value to true value), precision (agreement among repeated measurements), linearity (ability to produce proportional response over a range of concentrations), range (interval of concentrations that the method can measure with acceptable accuracy and precision), detection limit (lowest concentration that the method can detect with specified confidence level), quantitation limit (lowest concentration that the method can quantify with specified accuracy and precision), and robustness (ability of the method to remain unaffected by small variations in environmental or operational conditions).

添加您的观点

Santosh Jagtap

General Manager at ASolution Pharmaceuticals Pvt. Ltd.
举报内容
The mass balance should be established to prove stability indicating method. Force degradation and process related impurities to be considered while deciding the method.

已翻译

赞

4 How to monitor stability indicating parameters for GMP products?

Once you have validated your stability indicating methods for GMP products, monitoring is a process that ensures that your products maintain their quality, safety, and efficacy within the specified limits during storage, distribution, and use. This should follow the established stability protocol and testing plan, which includes collecting and labeling samples according to the sampling plan, performing tests according to the testing plan and recording the results, comparing the results with acceptance criteria and reporting any deviations or out-of-specification (OOS) findings, investigating the root cause and corrective actions for any deviations or OOS findings, updating the stability profile and shelf life of the product based on data analysis and evaluation, and reviewing and documenting the monitoring activities and outcomes.

添加您的观点

Santosh Jagtap

General Manager at ASolution Pharmaceuticals Pvt. Ltd.
举报内容
The product testing as per release specifications to be tested at the end interval of the proposed shelf life. Physical parameters at the last interval at least to be proven.

已翻译

赞

5 How to use stability indicating parameters for GMP improvement?

Using stability indicating parameters for GMP products is not only a compliance requirement, but also a great tool for continuous improvement. By measuring and monitoring these parameters, you can gain insights into the performance, quality, and reliability of your products and identify opportunities for improvement. For example, you can optimize your formulation, manufacturing process, and packaging to enhance the stability and shelf life of your products. Additionally, you can evaluate the impact of changes or modifications on the stability and shelf life of your products. Furthermore, implementing preventive and corrective actions can help to prevent or minimize degradation and quality issues. Finally, these efforts can reduce waste, rework, and recalls due to stability and quality failures while increasing customer satisfaction and trust by delivering consistent and high-quality products.

添加您的观点