Tag: GMP compliance

Deviations During IQ/OQ/PQ: How to Handle Them

Deviations During IQ/OQ/PQ: How to Handle Them Deviations During IQ/OQ/PQ: How to Handle Them The validation lifecycle in the pharmaceutical industry is a critical component ensuring that products meet specified requirements for quality and compliance. During installation qualification (IQ), operational…

Visual Inspection Acceptance Criteria in Cleaning Validation

Visual Inspection Acceptance Criteria in Cleaning Validation Visual Inspection Acceptance Criteria in Cleaning Validation In the pharmaceutical and biologics industries, ensuring that products are not only safe but also free from contamination is essential. This is where cleaning validation plays…

What to Include in a Deviation Log for Qualification Activities

What to Include in a Deviation Log for Qualification Activities What to Include in a Deviation Log for Qualification Activities In the pharmaceutical industry, maintaining compliance with regulatory requirements is paramount for ensuring the quality, efficacy, and safety of products.…

Swab and Rinse Sampling Strategy for Non-Product Contact Areas

Swab and Rinse Sampling Strategy for Non-Product Contact Areas Swab and Rinse Sampling Strategy for Non-Product Contact Areas Cleanliness in pharmaceutical manufacturing is paramount to ensure product quality and patient safety. Implementing effective swab and rinse sampling strategies for non-product…

Writing an Equipment Qualification Protocol: Structure & Format

Writing an Equipment Qualification Protocol: Structure & Format Writing an Equipment Qualification Protocol: Structure & Format The validation of pharmaceutical equipment is crucial to ensure that it meets the requirements for safety, efficacy, and quality. This article presents a step-by-step…

Cleaning Validation Failures Due to Poor Sampling Technique

Cleaning Validation Failures Due to Poor Sampling Technique Cleaning Validation Failures Due to Poor Sampling Technique In the pharmaceutical industry, ensuring the efficacy and safety of products is paramount. Cleaning validation is a critical component in this assurance, particularly in…

Sample Utility Qualification Protocol Template

Sample Utility Qualification Protocol Template Sample Utility Qualification Protocol Template This article serves as a comprehensive guide on the sterilisation validation process in pharmaceutical settings, aligned with regulatory expectations from entities such as the FDA, EMA, and WHO. It outlines…

Establishing Acceptance Criteria for Swab and Rinse Testing

Establishing Acceptance Criteria for Swab and Rinse Testing Establishing Acceptance Criteria for Swab and Rinse Testing In the pharmaceutical and biologics manufacturing industries, ensuring the efficacy of cleaning processes is paramount to maintain product integrity and compliance with regulatory expectations.…

Using SCADA Data for Utility Equipment Validation

Using SCADA Data for Utility Equipment Validation Using SCADA Data for Utility Equipment Validation In the pharmaceutical industry, achieving a seamless and compliant sterilization validation process is critical. With increasing regulatory demands and advanced technologies, such as SCADA (Supervisory Control…

How to Validate Rinse Sampling for CIP-Validated Equipment

How to Validate Rinse Sampling for CIP-Validated Equipment How to Validate Rinse Sampling for CIP-Validated Equipment Cleaning validation in pharmaceutical manufacturing is a critical component of ensuring product quality and safety. This article will provide a comprehensive, step-by-step tutorial on…