Risk Assessment for Cleaning Validation Risk Assessment for Cleaning Validation in Pharma Cleaning validation is a critical GMP activity that proves equipment is consistently cleaned to a level that prevents cross-contamination, microbial growth, and carryover of residues. A structured risk…
Checklist for Cleaning Validation CLEANING VALIDATION CHECKLIST 🧾 1. Documentation & Planning 🏭 2. Equipment Selection 🧪 3. Sampling & Testing 📊 4. Execution of Cleaning Validation Runs 📈 5. Acceptance Criteria 📂 6. Review & Report 🔁 7. Revalidation…
Media fill, also known as aseptic process simulation (APS), is a critical validation activity in sterile pharmaceutical manufacturing. It involves simulating the aseptic filling process using a sterile microbial growth medium (e.g., Tryptic Soy Broth) to assess the capability of…
Flow Charts in Pharma – Overview & Key Examples Flow charts in the pharmaceutical industry are visual tools used to represent step-by-step processes, ensuring clarity, compliance, training, and audit readiness. They help standardize workflows across departments like Quality Assurance, Production,…
HR Policies in Pharma are tailored to ensure regulatory compliance, employee safety, and operational efficiency in a highly controlled and quality-driven environment. Here’s a comprehensive overview: ✅ Key HR Policies in the Pharmaceutical Industry 1. Recruitment & Selection Policy 2.…
1. Suggested Site Map (for FLUID BED DRYER section) Main Product Page Sub-pages / Sections (can be separate pages or sections on same page): 2. Homepage Hero Section – Main Product Page Title (H1):Fluid Bed Dryer (FBD) for Pharmaceutical &…
A Walk-In Stability Chamber is a large, temperature- and humidity-controlled environment used in pharmaceutical manufacturing to conduct stability studies on drug products, active pharmaceutical ingredients (APIs), and formulations. These chambers are crucial for evaluating how products behave under different environmental…
Design of Experiments (DoE) is a structured, statistical method used in the pharmaceutical industry to determine the relationship between multiple input variables (factors) and the resulting outputs (responses). It is a cornerstone of Quality by Design (QbD) and is widely…
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…