Process Charactertization is different than proving your process works. But proving you understand WHY it works. And there is a disciplined, statistical way to do this that most teams ignore. I have reviewed Process Characterization (PC) protocols & found a pattern. – Run Design of Experiments (DoE) without clear objectives.– Test parameters that “feel” critical…
Effective recall management enables organizations to ensure swift and effective removal of potentially harmful or non-compliant products, protecting public health and ensuring regulatory compliance. Regulatory Requirements Types of Recalls Recall Classifications Recall Process Identify and Evaluate Decision to Recall Notification Execution Documentation Effectiveness Check Closeout Recall Committee Members and Roles Read also: Resource Person: Alaaeldin…
Regulatory Requirements Adhering to FDA and EU GMP mandate robust complaint management process and reporting of serious quality defects Types of Market Complaint Classification of Market Complaint 1. Critical Market Complaint Complaints that pose a serious threat to patient safety or regulatory compliance. Example: 2. Major Market Complaint Complaints that could affect product efficacy or…
Process Capability & Performance Indicators (Pp, Ppk, Cp, Cpk) are specification indicators relative to process dispersion and process centering. Process capability is a statistical measurement of a process’s ability to produce parts within specified limits consistently, to meet the design specification for a service or a product. Process capability is expressed as 6σ,…
Have you ever wondered how pharmaceutical companies ensure the consistency and quality of their tablet formulations? In this post, we’ll explore how stratified sampling can be used to establish a strong correlation between these two important factors. Let’s dive in! By establishing a correlation between blend assay results and tablet content,…
As a life science sector audit and inspection are common terms in pharmaceutical industry. Here we going to mention a list of criteria of maintaining audit and inspection readiness at all times in pharma industry. 1. Clear Communication Channel Manufacturing and quality teams should establish clear communication channels. Regular meetings and discussions enable both…
