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Manufacturing processes must be clearly defined and controlled. All critical processes are validated [8] to ensure consistency and compliance with specifications. Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated [9] as necessary.
Process qualification is the qualification of manufacturing and production processes to confirm they are able to operate at a certain standard during sustained commercial manufacturing. Data covering critical process parameters must be recorded and analyzed to ensure critical quality attributes can be guaranteed throughout production. [ 1 ]
Advanced product quality planning (APQP) is a framework of procedures and techniques used to develop products in industry, particularly in the automotive industry. It differs from Six Sigma in that the goal of Six Sigma is to reduce variation but has similarities to Design for Six Sigma (DFSS).
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.
The PPAP process is designed to demonstrate that a supplier has developed their design and production process to meet the client's requirements, minimizing the risk of failure by effective use of APQP. Requests for part approval must therefore be supported in official PPAP format and with documented results when needed.
Quality management software can be integrated with manufacturing execution systems (MES). A MES is a complete, dynamic software system for monitoring, tracking, documenting, and controlling the manufacturing process from raw materials to final products. [14] When combined with QMS, these systems: ensure compliance; enable quality programs ...
Six Sigma (6σ) is a set of techniques and tools for process improvement.It was introduced by American engineer Bill Smith while working at Motorola in 1986. [1] [2]Six Sigma strategies seek to improve manufacturing quality by identifying and removing the causes of defects and minimizing variability in manufacturing and business processes.
A "c" or "C" is sometimes added to the front of the initialism. The preceding "c" stands for "current." For example, cGMP is an abbreviation for "current good manufacturing practice". The term GxP is frequently used to refer in a general way to a collection of quality guidelines. [1]