Compliance

Product Recall Management in Pharmaceutical Industry

Product Recall Management in Pharmaceutical Industry

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…

Market Complaint Management in Pharmaceutical Industry

Market Complaint Management in Pharmaceutical Industry

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 and Performance Indicators (Pp, Ppk, Cp, Cpk)

Process Capability and Performance Indicators (Pp, Ppk, Cp, Cpk)

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,…

Correlating Blend Assay and Tablet Content with Stratified Sampling in Pharma
|

Correlating Blend Assay and Tablet Content with Stratified Sampling in Pharma

    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,…

Audit and Inspection Readiness in Pharmaceutical Industry
|

Audit and Inspection Readiness in Pharmaceutical Industry

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…