Sie sind auf Seite 1von 12

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.

Items For Self Inspection


List for self inspection should be estabilshed to

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

Equipment Production and in-process controls

Quality control
Documentation Sanitation and hygiene

Validation and revalidation programmes


Calibration of instruments or measurement systems Recall procedures Management of complaints Control of labels and Result of previous self inspection and any corrective

steps taken

Team Of Self Inspection


Management should appoint a team of self inspection consisting of at least three members. The members of the team may be appointed from inside or outside the company. Each members should be independent in performing the inspection and evaluation.

Coverage and Frequency of Self Inspection


Self inspection may be conducted by part of unit depending on the company requirements, however, a complete self inspection should be conducted at least once a year. The frequency should be stated in the procedure for self inspection

Self Inspection Report


A report shoul be made at the completion of self

inspections. The report should include:


Self inspections results Evaluation and conclusions and Recommended corrective actions

Follow up action
The company management should be evaluate

both the self inspection report and the corrective actions.

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

Suppliers Audits and Approval


The head Quality Management (Quality

Assurance) should have responsibility together with other relevant departments for approving suppliers who can reliably supply starting and packaging materials that meet estabilshed specifications.

A list of approved suppliers of starting and

packaging materials should be estabilshed and reviewed.


Before suppliers are approved and included in the

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

Health Products and Food Branch

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