GxP Cellators

  A   Good Clinical Practice Quality Management System (GCP QMS)   is a structured framework that ensures sponsor companies maintain compliance with global regulatory standards throughout a clinical trial’s lifecycle. Regulatory bodies such as the   FDA (U.S. Food and Drug Administration) ,   ICH (International Council for Harmonisation) , and   EMA (European Medicines Agency)   emphasize the critical role of a robust QMS in safeguarding subject safety, data integrity, and ethical conduct in clinical research. Technical Writers | Quality Management System | Technical Writing GCP QMS Requirements for Sponsor Companies Sponsor companies bear the ultimate responsibility for the initiation, management, and financing of clinical trials. Their QMS must be capable of: Ensuring compliance  with ICH E6(R3), FDA 21 CFR Parts 312, 50, 54, and EMA guidelines Managing risk  and quality across the clinical development spectrum Overseeing vendors, CROs , an...

  Advanced Therapy Medicinal Products (ATMPs) are an emerging class of medicines based on genes, cells, or tissues that offer revolutionary treatment options, especially for diseases that are currently untreatable or poorly managed with conventional pharmaceuticals. What are ATMPs? Advanced Therapy Medicinal Products (ATMPs) are innovative biopharmaceuticals that utilize genes, cells, or engineered tissues to treat, prevent, or potentially cure a wide range of serious diseases. These therapies are particularly promising for conditions such as genetic disorders, cancers, autoimmune diseases, and tissue/organ damage, where conventional pharmaceuticals often fall short. Types of ATMPs: 1.     Gene Therapy Medicinal Products (GTMPs): Deliver functional genes to replace faulty ones or to provide new functions. Example: Zolgensma (for spinal muscular atrophy). Revolution in Cell and Gene Therapy | Cell Therapy | Cleanrooms 2.     Somatic Cell The...

  What is Media Fill? A Media Fill , also known as a Process Simulation , is a critical microbiological validation technique used in aseptic manufacturing . This test replaces the actual pharmaceutical product with a sterile nutrient-rich growth medium (commonly Tryptic Soy Broth) to simulate the entire aseptic production process. The purpose is to assess whether the manufacturing operations, including equipment, environment, and personnel practices, can consistently prevent microbial contamination. It is a fundamental requirement to ensure the sterility of parenteral drug products and to meet international regulatory standards. Vaccines | Vaccine Facility Qualifications | Vaccine Cleanrooms   Why is Media Fill Required? Media Fills are essential for: Demonstrating the sterility assurance of aseptic processing Confirming that procedures, personnel, equipment, and environment consistently prevent contamination Meeting global regulatory requirements for sterile pharmaceutical p...

What is GDP for pharmaceutical distribution? Good Distribution Practices (GDP) are international guidelines to ensure that medicines are consistently stored, transported, and handled under suitable conditions to ensure quality, safety, and efficacy. GDP focuses not only on warehouses and wholesalers but also heavily on transportation (trailers, shipping vessels, etc.). Transportation must preserve integrity , prevent contamination , maintain controlled conditions (especially temperature-sensitive products), and protect against theft or counterfeiting . Good Distribution Practices (GDP) Certification General Requirements for Trailers and Shipping Vessels (GDP-compliant Transport) To qualify shipping trailers and vessels under GDP: Temperature Control: Capability to maintain required conditions (e.g., 2–8°C for refrigerated, 15–25°C for room temperature). Calibration and Qualification: Temperature mapping (thermal qualification). Equipment calibration (temperature sensors, humidity ...