Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.

ISO 9001:2015 specifies requirements for a quality management system when an organization:

• needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
• aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

ll the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

Six Sigma focuses on reducing process variation and enhancing process control, whereas lean drives out waste (non-value added processes and procedures) and promotes work standardization and flow. The distinction between Six Sigma and lean has blurred, with the term "lean Six Sigma" being used more and more often because process improvement requires aspects of both approaches to attain positive results.

Lean Six Sigma is a fact-based, data-driven philosophy of improvement that values defect prevention over defect detection. It drives customer satisfaction and bottom-line results by reducing variation, waste, and cycle time, while promoting the use of work standardization and flow, thereby creating a competitive advantage. It applies anywhere variation and waste exist, and every employee should be involved.