In the Pharmaceutical Industry there is some possibility of contamination and cross-contamination of products due to inadequate washing of shared facilities. This can lead to severe hazards for the patient, therefore any contamination as well as cross-contamination cannot be afforded in (imagine, for ...

Cleaning Validation is typically performed according to a master validation plan (Cleaning Validation Plan) that will guide the cleaning validation approach and dedicated Cleaning Validation Protocols in which all the relevant cleaning procedures, equipment, areas, analytical methods, sampling plan and ...

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 ...

The installation qualification confirms that the specified equipment, including all parts, spares, service gauges, and other necessary materials, was delivered and installed in accordance with the planned schedule and in flawless condition. It serves as written proof that the apparatus was correctly ...

The following are the importance of equipment validation in pharmaceutical industries: • By minimizing rejects, reworks, and downtime, as well as by reducing the risk of regulatory non-compliance, equipment validation reduces costs. • Customer happiness is really high. • Testing and calibrations ...

Computer validation planning consists of a Computer Validation Plan (approach), specific activities required to carry out the plan, and a Computer Validation Report as documented assurance that all activities required to validate the computerized system have been successfully completed. A. Computer ...

Pharmaceutical manufacturing is a perfectly systematic process that primarily relies on quality control to produce quality products. The goal of quality control is to reduce batch failures and defects during manufacturing by taking steps at every manufacturing stage. Therefore, the sampling of the intermediate ...