Tag: process validation

How to Justify Process Ranges Using Scientific Data

How to Justify Process Ranges Using Scientific Data How to Justify Process Ranges Using Scientific Data Justifying process ranges is a critical component of validation in quality assurance in pharmaceutical and biologics manufacturing. It involves a systematic approach to determine…

Understanding Process Capability in Pharmaceutical Validation

Understanding Process Capability in Pharmaceutical Validation Understanding Process Capability in Pharmaceutical Validation Process capability is an essential consideration in pharmaceutical validation, especially when aligning with regulatory standards such as ISO 14644-3. This step-by-step guide aims to provide QA, QC, and…

Lifecycle Approach to Maintaining and Reassessing CPPs

Lifecycle Approach to Maintaining and Reassessing CPPs Lifecycle Approach to Maintaining and Reassessing CPPs The lifecycle approach to maintaining and reassessing Critical Process Parameters (CPPs) is not only essential for operational efficiency in pharmaceutical manufacturing processes but is also crucial…

Impact of Equipment Variability on Process Parameter Control

Impact of Equipment Variability on Process Parameter Control Impact of Equipment Variability on Process Parameter Control This tutorial provides a detailed overview of the impact of equipment variability on process parameter control within the pharmaceutical industry. It traces the validation…

Automated Systems for Monitoring Critical Process Controls

Automated Systems for Monitoring Critical Process Controls Automated Systems for Monitoring Critical Process Controls In the pharmaceutical and biologics industries, the validation of processes is critical to ensuring product quality and regulatory compliance. As technologies evolve, the need for automated…

Documenting and Verifying Process Parameters in Validation Protocols

Documenting and Verifying Process Parameters in Validation Protocols Documenting and Verifying Process Parameters in Validation Protocols Step 1: User Requirement Specification (URS) and Risk Assessment The validation lifecycle commences with the establishment of a User Requirement Specification (URS). This document…

Role of Design of Experiments (DoE) in Determining CPPs

Role of Design of Experiments (DoE) in Determining CPPs Role of Design of Experiments (DoE) in Determining CPPs Cleaning validation in the pharma industry is a critical aspect of ensuring product safety and efficacy. With the strict regulatory requirements outlined…

Case Study: CPP Control in Tablet Compression Process

Case Study: CPP Control in Tablet Compression Process Case Study: CPP Control in Tablet Compression Process This article serves as a practical guide for pharmaceutical professionals focusing on cleaning validation in the pharmaceutical industry, particularly in the context of a…

CPP Deviations: Root Cause Analysis and CAPA Strategies

CPP Deviations: Root Cause Analysis and CAPA Strategies CPP Deviations: Root Cause Analysis and CAPA Strategies Step 1: Understanding User Requirements Specification (URS) and Risk Assessment In the validation lifecycle, the first step involves the development of the User Requirements…

How to Establish Control Limits for Key Manufacturing Parameters

How to Establish Control Limits for Key Manufacturing Parameters How to Establish Control Limits for Key Manufacturing Parameters Establishing control limits for key manufacturing parameters is a crucial aspect of process validation in the pharmaceutical industry. This article provides a…