Search results
Results from the WOW.Com Content Network
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
[2] [3] The goal of it is provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the automotive industry supply chain and assembly process. The standard was developed by International Automotive Task Force (IATF). It harmonises the country-specific regulations of quality management systems. [4]
Process performance qualification protocol is a component of process validation: process qualification.This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
Value-stream mapping has supporting methods that are often used in lean environments to analyze and design flows at the system level (across multiple processes).. Although value-stream mapping is often associated with manufacturing, it is also used in logistics, supply chain, service related industries, healthcare, [5] [6] software development, [7] [8] product development, [9] project ...
A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. It is a key document in the GMP ( Good manufacturing practice ) regulated pharmaceutical industry as it drives a structured approach to validation ...
Business process mapping, also known as process charting, has become much more prevalent and understood in the business world in recent years. Process maps can be used in every section of life or business. The Major Steps of Process Improvement using Process Mapping Process identification - identify objectives, scope, players and work areas.
A process flow diagram (PFD) is a diagram commonly used in chemical and process engineering to indicate the general flow of plant processes and equipment. The PFD displays the relationship between major equipment of a plant facility and does not show minor details such as piping details and designations.
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).