Self Inspection and Quality Audits
Self Inspection and Quality Audits
Self Inspection and Quality Audits
PRINCIPLE
The purpose of self inspection is to evaluate the
manufacturers compliance with Good Manufacturing Practices on all aspocts of production and quality control.
The self inspection program should be designed to
detect any short-coming towards the implemantation of Good Manifacturing Practices an to recommend the necessary corrective actions.
provide a minimum and uniform standard of requirements. These may include questionnaires on Good Manufacturing Practices requipments covering at least the following items:
Personnel Premises including personnel facilities Maintenance of buildings and equipment Storage of starting materials, packaging materials and
finished products
Quality control
Documentation Sanitation and hygiene
steps taken
Follow up action
The company management should be evaluate
Quality Audits
It may be useful to supplement self inspections
with a quality audit. A quality audit consists of an examination and assessment of all or part of a quality management system with specific purpose of improving it. A quality audit isussually conducted by outside or independent specialist or a team designated bythe management for this purpose. Such audits may also be extended to suppliers and contractors
Assurance) should have responsibility together with other relevant departments for approving suppliers who can reliably supply starting and packaging materials that meet estabilshed specifications.
approved suppliers list or specification, they should be avaluated. If an audits is required, it should determine the suppliers ability to conform with GMP standards.
All estabilshed suppliers should be evaluated
regulary
Referance
BPOM. 2006. Pedoman CPOB. Jakarta: BPOM
Inspectorate: Good Manufacturing Practices (GMP) Guidelines 2009 Edition, Version 2 . 2009., Canada Quality assurance of pharmaceuticals: A compendium of guidelines and related materials, Volume 2, 2nd updated edition. WHO 2007