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In biopharmaceutical manufacturing, not all processes and equipment carry the same risk. Yet, traditional validation approaches often treat them equally, leading to unnecessary effort, cost, and documentation. Risk-Based Validation (RBV) addresses this by focusing resources on areas that matter most for product quality and patient safety.
In the pharmaceutical industry, cleaning validation isn’t just a regulatory requirement—it’s a critical part of ensuring patient safety, product integrity, and GMP compliance.
Both Design Review (DR) and Design Qualification (DQ) are early lifecycle verification activities in the C&Q process. They support leveraging later in Installation Qualification (IQ) and Operational Qualification (OQ) by ensuring the foundation (i.e., the design) is solid and compliant.
Heating, Ventilation, and Air Conditioning (HVAC) systems are critical components in pharmaceutical manufacturing environments. These systems directly influence product quality, regulatory compliance, and environmental control, especially in cleanrooms and classified areas. Adhering to Current Good Manufacturing Practices (cGMP), as outlined by regulatory authorities such as the FDA, EMA, and WHO, is essential to ensure that HVAC systems are properly designed, validated, and maintained to prevent contamination and ensure product safety.
Automated parts washers are essential in pharmaceutical manufacturing for cleaning equipment parts with consistency and reduced variability compared to manual cleaning. This improves the ease of validation and ensures critical cleaning parameters (temperature, time, agent concentration, etc.) are consistently applied.
Controlled Temperature Units i.e. Fridges, Freezers, Incubators or Coldroom are most commonly used in pharmaceutical or biopharmaceutical industries to store medicinal products, intermediates or raw materials as per the recommended storage conditions and also for the manufacturing process. Highly regulated industries require to qualify and validate these units to verify their capability of storing products or running process that do not compromise products quality or shelf life. The purpose of this article is to summarize the general industry practices and regulatory requirements/guidelines for the qualification or validation activities performed that ensure that CTUs can be used routinely to meet the user requirements and to maintain product integrity and quality.
The Biowelder® TC is an automated device for making sterile connections between thermoplastic elastomer (TPE) tubing elements. This proven technology uses unique rotating tube holders to connect dry- or liquid-filled TPE tubing and ensures total containment of process fluids by reconnecting discarded tube ends. The TPE tubing are typically used for safe fluid transfer during pharmaceutical manufacturing process. These tubings are weldable and sealable which simplifies operations without the need for extra connectors.
At Pharma Troubleshooting, I am dedicated to providing accurate and reliable information to our readers. Here I bring my years of experiences in the pharmaceutical industry, biopharmaceutical industry ensuring that you get the best learning experiences with me. I have 11 years of working experiences in pharmaceutical, biopharmaceuticals or medical device companies with some renowned pharma giants i.e. Novartis, Regeneron, Johnson & Johnson, Beckman Coulter etc. in areas of Equipment & Facility Qualification and Validation, Cleaning Validation & Process Validation.
I want share my learnings and expertise to compile as a notebook and hope it might help you as a reader to learn and grow.