Page 13 - PPTL.QM.001 Iss 01 - ISO 9001 Quality Manual - Full [Unsigned]

QUALITY MANUAL

PHILLIPS PHARMACEUTICALS (TANZANIA) LIMITED

DOCUMENT NUMBER ISSUE NUMBER SUPERSEDES EFFECTIVE DATE

PPTL/QM/001 02 01 14.12.2018

6.3 PLANNING OF CHANGES

When PPTL determines the need for changes to the QMS, the changes shall be carried out in a planned manner. The

following consideration shall be made:

• The purpose of the changes and their potential consequences.

• The integrity of the Quality Management System.

• The availability of resources.

• The allocation or reallocation of responsibilities and authorities.

PPTL has established a Change Control Procedure, PPTL/SOP/QA/007 to ensure that all major changes related to the

maintenance of the PPTL QMS and Good Distribution Practice are reviewed, approved and communicated

appropriately before implementation.

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