It controls Temperature, Humidity and Air quality inside a building. HVAC technology aims to provide thermal comfort and acceptable indoor air quality. HVAC system design is a sub discipline of mechanical engineering, based on the principles of thermodynamics, fluid mechanics, and heat transfer. The ...

1. What is an Active Pharmaceutical Ingredient? An active Pharmaceutical Ingredient (API) is any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such ...

Definition of OOS and OOT Out of specification (OOS) is defined as a result that falls outside the predetermined specifications or established acceptance criteria set by the manufacturer and/or the laboratory. In simple terms, the result of a stability test conducted by a Quality Analyst (QA) should ...

1. Master Batch Record (MBR): This is a comprehensive document that provides detailed instructions for the manufacturing of a specific product. It includes information on raw materials, equipment, processing steps, and quality control tests. 2. Batch Manufacturing Record (BMR): This record is created ...

1. Identification: Your first step should be to get a clear picture of what happened. Before packaging, deviations can occur during the sampling and testing of raw materials and/or the finished product. When your products fail to meet industry standards, you may receive customer complaints or notifications. All ...

A deviation is any departure from approved processes, procedures, instructions, specifications, or established standards. In the pharmaceutical industry, deviations can occur during drug product development, manufacturing, labeling, packing, sampling, testing, storage, distribution, and other processes. The ...

1. Ventus Pharma Address – SCO No. 8, 2nd Floor, Swastik Vihar, MDC Sector – 5, Panchkula, Haryana Contact No. – +91 9216504338 Email Id. – girjesh@ventuspharma.com 2. Sun Pharmaceutical Industries Address: Goregaon, Mumbai, India 3. Divi’s Laboratories Headquarters: Hyderabad, India 4. ...

The main purpose of Cleaning Validation is to prove the effectiveness and consistency of cleaning in a given pharmaceutical production and packaging equipment, to prevent cross-contamination and adulteration of drug products with other active ingredients (APIs) or microbiological contamination. The goal ...

• Quality. • Customer—patient satisfaction. • It has been built into the product. • Assurance of quality. • Time bound. • Process optimization. • Reduction of quality cost. • Nominal mix-ups, and bottle necks. • Minimal batch failures leads to improved efficiency and productivity. • ...

Test parameters during validation and its frequency are given below: a) Test for oil mists – Every 6 months once b) Test for moisture content – Every 6 months once c) Particulate count (Non-viable) – Every 6 months once d) Sterility test (Aseptic area locations) – Every 6 months ...