IN-PROCESS CONTROLS IN THE MANUFACTURING PROCESS DESIGN AND DEVELOPMENT OF OPHTHALMIC APPLICATIONS

Facilities and processes involved in pharmaceutical production affects the quality of the product. manufacturing processes should meet the requirements of Good Manufacturing Practices, especially with regard to cross-contamination. Raw material and equ inspections as well as in-process controls are an integral part of process control. The development of a drug product is a lengthy process involving drug discovery, laboratory testing, animal studies, clinical trials and regulatory registration. Many regulatory agencies across the world require that the drug product should be tested for its identity, strength, quality, purity and stability before it can be released for distribution and use. For this reason, pharmaceutical validation and process controls are important in spite of the problems that may be encountered while performing the same. The following information is intended to provide very broad guidelines concerning the main steps to be followed during production of ophthalmic preparations, indi those that are the most important. Throughout manufacturing, certain procedures should be validated and monitored by carrying out appropriate in process controls