Validation
Smoke Study in Clean Rooms of Pharmaceuticals Clean rooms play a pivotal role in the pharmaceutical industry, providing controlled environments where critical processes are conducted to ensure product quality, safety, and efficacy. A smoke study is a fundamental test performed in clean rooms to evaluate the effectiveness of airflow patterns, ventilation, and containment systems. The … Read more
HPLC Method Validation: Ensuring Accuracy and Reliability in Pharmaceutical Analysis High-Performance Liquid Chromatography (HPLC) is a widely used analytical technique in the pharmaceutical industry for the analysis of drugs, impurities, and related substances. To ensure the accuracy and reliability of HPLC results, HPLC Method Validation is essential. This blog post provides a comprehensive overview of … Read more
Validation in Pharmaceuticals: Ensuring Quality, Safety, and Compliance Validation in Pharmaceuticals plays a critical role in the pharmaceutical industry by ensuring that processes, systems, and equipment consistently meet predefined requirements. It is a systematic approach to confirm and document that pharmaceutical products and processes meet the desired quality, safety, and efficacy standards. This blog post … Read more
Manufacture of the finished Dosage Form – QbD: New EMA Guideline The European Medicines Agency (EMA) published its new guideline on Manufacture of the finished dosage form on August 14, 2017. The guideline replaces the “Note for Guidance on Manufacture of the Finished Dosage Form” (dated April 1996) and will enter into effect on February 14, 2018. … Read more
VALIDATION OF FREEZE DRYER “In freeze-drying, water is removed from the frozen state by sublimation, i.e., direct change of water from solid into vapor without conversion to a liquid phase”. Used for drying of a no. of products. Especially, Blood plasma and its fractionated products. Bacterial and viral cultures. Human tissues. Antibiotics and plant extracts. … Read more
Process Validation Programme OBJECTIVE : To lay down the procedure for the process validation of products to ensure that a specific process will consistently produce the product meeting its pre-determined specifications and quality attributes. RESPONSIBILITY : Research Development to prepare and execute the validation protocol and to prepare a final report on Process Validation. Production to execute the … Read more