Self-inspection in the pharmaceutical industry is a critical aspect of Good Manufacturing Practices (GMP) compliance. It involves an internal audit conducted by a pharmaceutical company to evaluate its processes, facilities, and systems to ensure they meet regulatory requirements and internal…
An Environment Monitoring System (EMS) in pharmaceuticals ensures that critical areas comply with the regulatory requirements for cleanliness, temperature, humidity, pressure, and microbial contamination. It is essential for maintaining product quality, ensuring patient safety, and meeting Good Manufacturing Practice (GMP)…
Analytical Research & Development (Analytical R&D) in pharma is the function that develops, validates, and transfers test methods needed to characterize materials and ensure drug products meet quality requirements throughout development and commercialization. It bridges discovery, formulation/process development, manufacturing, QC,…
Computer System Validation (CSV) of QC Instruments in Pharma is a structured process used to ensure that computer-based systems (like analytical instruments with software) perform reliably and accurately, complying with regulatory standards such as 21 CFR Part 11, Annex 11,…
A Project Validation Plan (PVP) for Quality Control (QC) facilities outlines the structured approach to ensure that the QC facilities comply with regulatory standards, operate as intended, and meet the requirements for testing pharmaceutical products. A Project Validation Plan (PVP)…
Contamination and Cross-Contamination in Pharmaceuticals are critical concerns in maintaining product quality, safety, and regulatory compliance. Here’s a clear breakdown of both concepts, causes, risks, and control strategies: 1. Definitions Contamination Unintended introduction of impurities (chemical, microbial, physical, or foreign…
Pharmaceutical formulation and development involve transforming active pharmaceutical ingredients (API’s) into safe, effective, and patient-friendly medications. This process encompasses several key stages: 1. Pre-formulation Studies 2. Formulation Design 3. Process Development and Optimization 4. Quality by Design (QbD) 5. Regulatory…
A multi mill (also called a multi-mill, communiting mill, or multimill) is a high-speed size-reduction and granulation machine widely used in pharma to reduce lumps, de-agglomerate, and produce uniform granules/powders before blending, compression, capsule filling, or coating. It works by…
A vibro sifter (vibro separator / gyratory sifter) is a GMP equipment used in pharma to screen, grade, and de-lump powders or granules by passing material through one or more mesh screens using controlled vibration. Its main purpose is to…
AHU Qualification in Pharma – Step-by-Step Guide AHU Qualification in Pharma are the heart of HVAC systems in pharmaceutical facilities. They control temperature, humidity, air cleanliness, and pressure differentials – all critical for maintaining classified area conditions as per GMP.…