Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOChapter 2: Quality systemPrincipleThe Quality system - in the form of organisational structure, procedures, processes andresources needed to implement the quality policy - should be described in a quality manual.The quality manual should cover relevant EN ISO 9001 and GMP requirements, describe thedocumentation hierarchy and indicate how the quality system is managed.The need for quality planning is an important feature of the QMS. It requires that adequateconsideration is given to an activity before implementation, thereby reducing the risk and costof failure.2.1 Quality manual2.1.1 The quality manual is the master quality document and, as such, should provide anoutline of, and directory to, the quality system. It should cover relevant ISO 9001and GMP quality management requirements2.1.2 The quality manual should be positioned at the head of the documentation hierarchy,and be supported by other document groups such as policies, Guidelines, procedures(such as Standard Operating Procedures) etc.2.1.3 The quality manual should be used as a basis for auditing the performance of theQMS.2.1.4 The quality manual should be written in a clear, concise and user-friendly style sinceit will be read, and needs to be understood, by all grades of staff. It should also beopen to inspection by external auditors and (possibly) by customers.2.2 Quality system procedures2.2.1 The quality system should ensure that all quality related activities are documentedand carried out in a systematic and approved manner.2.2.2 Duplication of content between documented procedures (e.g. operating proceduresversus training modules) should be avoided in order to minimise the risk ofdocumentation overload.2.2.3 Procedures should, where appropriate, address control of the horizontal (crossfunctional)communication interfaces as well as vertical communication in theorganisation.14