Establishing acceptance criteria during method validation

Establishing acceptance criteria during method validation:
A method validation is necessary when a new method has been established and is supposed to use routinely for the intended purpose. There are requlatory requirements and guidelines to be applied to take criticali points into account during method validation. i The ICH Q2(R1) is one of them. This guideline "Validation of analytical procedures: text and methodology", published by the ICH, offers help with respect to number of parameters to be considered during validation, but more often not on the acceptance criteria. This article is aimed to provide quidance on the acceptance criteria which are accepted by most of the regulators.



Comments

Post a Comment

Popular posts from this blog

Understanding Quantitative, Qualitative, and Limit Tests in Pharmaceutical Quality Control

In pharmaceuticals, quantitative, qualitative, and limit tests refer to different approaches for analyzing drugs and their components: 1 . Quantitative Test: This determines the exact amount or concentration of a specific substance in a pharmaceutical product. It provides precise measurements, such as the amount of active pharmaceutical ingredient (API) or impurities present. For example, assays like High-Performance Liquid Chromatography (HPLC) are used to quantify substances. 2. Qualitative Test: This identifies the presence or absence of a particular substance but does not measure its amount. These tests confirm the identity of the compound, ensuring that the correct API is present. Techniques such as Infrared (IR) spectroscopy or Thin Layer Chromatography (TLC) can be used for qualitative analysis. 3. Limit Test: This is a type of semi-quantitative test used to check whether the concentration of a substance (like impurities) in a sample is within prescribed limits. It doesn’t prov...
Read more

USFDA Inspection Types

The FDA and States assisting the FDA under contract or cooperative agreements, in general, perform three types of inspections: surveillance, compliance follow up, and for-cause. Surveillance inspections are conducted to assess a facility’s or farm’s compliance with a regulation or to focus on an emerging trend in food safety. Surveillance inspections fall into two categories, routine and targeted. Routine inspections of facilities and farms are conducted to assess regulatory compliance. The FDA Food Safety Modernization Act mandates an inspection frequency of at least once every three years for domestic high-risk facilities and at least once every five years for non-high-risk facilities. In addition, the Food and Drug Omnibus Reform Act of 2022 mandated annual inspections of infant formula manufacturers in accordance with a risk-based approach. If necessary, inspections can be conducted more frequently. The FDA seeks to achieve comparable coverage of imported foods using an array of re...
Read more

Handling of Market Complaints and Their Importance in the Pharmaceutical Industry

In the pharmaceutical industry, market complaints serve as a critical feedback mechanism that helps maintain the safety, quality, and efficacy of products. Efficient handling of these complaints not only protects patient health but also strengthens the company's reputation and regulatory compliance. This blog post is to explore the importance of market complaints and best practices for managing them effectively. The Importance of Market Complaints Ensuring Patient Safety The primary objective of pharmaceutical companies is to provide safe and effective products to patients. Market complaints, especially those related to adverse drug reactions or product defects, can indicate potential risks. Immediate investigation and corrective action help prevent further harm to patients. Maintaining Product Quality Market complaints can reveal issues with the product’s quality, such as impurities, packaging defects, or labeling errors. Addressing these complaints promptly ensures that quality i...
Read more