Non-Conformance in Pharma – Overview Non-conformance in the pharmaceutical industry refers to any deviation from approved specifications, procedures, or regulatory requirements that may impact product quality, safety, efficacy, or compliance. ❗ What Is a Non-Conformance? A non-conformance (NC) is any…
Introduction: Microbiology instruments play a critical role in ensuring product quality and patient safety in pharmaceutical manufacturing. Risk assessment of these instruments is essential to identify potential failures, contamination sources, and compliance gaps that could impact test reliability or data…
In the pharmaceutical industry, layouts play a critical role in ensuring compliance with GMP, product quality, operational efficiency, and contamination control. Different areas of a pharmaceutical facility require different types of layouts depending on the type of manufacturing (sterile vs.…
A Risk Assessment for QC instruments in the pharmaceutical industry is critical to ensure accurate, reliable, and compliant data. The purpose of this assessment is to identify, assess, and mitigate potential risks associated with the use, maintenance, and performance of…
A Rapid Mixer Granulator (RMG), also called a High-Shear Mixer Granulator, is a core granulation machine used in solid oral dosage manufacturing to convert powders into uniform, free-flowing granules suitable for compression or capsule filling. It achieves rapid, controlled granulation…
In the pharmaceutical industry, “deviation in pharma” refers to any departure from approved processes, procedures, specifications, or expected outcomes. These deviations can occur during manufacturing, testing, packaging, or storage of pharmaceutical products. Managing deviations is critical to ensure product quality,…
Types of Market Complaints Complaint Handling Process in Pharma Regulatory Expectations Complaint Trending and Analysis Best Practices Q1: What is a market complaint?A: A market complaint is any written, verbal, or electronic communication from a customer, patient, or healthcare provider…
“Incidents in Pharma” can refer to a wide range of unplanned events or deviations that occur during pharmaceutical manufacturing, testing, storage, or distribution. These incidents can affect product quality, patient safety, regulatory compliance, and operational efficiency. Common Types of Incidents…
Change Control in pharma is a structured, documented process used to manage any planned change that may impact product quality, patient safety, regulatory compliance or validated status of facilities, utilities, equipment, documents and computerized systems. A robust change control system…
In pharma, artworks are the controlled master designs for all printed packaging components—cartons, labels, foils, leaflets, shippers, inserts, booklets, and sometimes on-pack overprint layouts. They translate the approved product information (name, strength, composition, warnings, storage, manufacturer details, batch/expiry fields, barcodes/2D…