Inspeksi Diri dan Audit Mutu

T N Saifullah S
Laboratorium Teknologi Farmasi
Fakultas Farmasi UGM
 Principle (1)
• Purpose of self-inspection is to evaluate whether a
company’s operations remain compliant with GMP

• Assists in ensuring quality improvement

• The programme should

 Cover all aspects of production and quality control
 Be designed to detect shortcomings in the implementation
of GMP
 Recommend corrective actions
 Set a timetable for corrective action to be completed
 Principle (2)
• Performed routinely
• Also on special occasions such as
Recalls
Repeated rejections
When a GMP inspection is announced by the
national drug regulatory authority
 Principle (3)
• Self-inspection team should consist of personnel
who:
 Can evaluate the situation objectively
 Have no conflict of interest, have no revenge in mind
 Should have experience as observers of a self-
inspection team before becoming a team member
 Can be lead self-inspector with experience as team
member

• Procedure should be documented

• Effective follow-up programme
1. Self-inspection - informal
(daily) Immediate correction

2. Self-inspection - formal
(quarterly) Improve systems

3. QA - Internal Confirm compliance

(half-yearly)
 Items for Self-Inspection (1)

• Written instructions provide minimum and uniform

standard

• Covering all aspects of GMP:

o Personnel
o Premises including personnel facilities
o Maintenance of buildings and equipment
o Storage of starting materials and finished products
o Equipment
o Production and in-process controls
o Quality control
 Items for Self-Inspection (2)

o Documentation
o Sanitation and hygiene
o Validation and revalidation programmes
o Calibration of instruments or measurement systems
o Recall procedures
o Complaints management
o Labels control
o Results of previous self-inspections and
any corrective steps taken
 The Self-Inspection Team

• Team appointed by management, with:

 Authority
 Sufficient experience
 May be from inside or outside the company
 Experts in their own field
 Familiar with GMP

• Frequency should be at least once a year

 May depend on company requirements
 Size of the company and activities
 Carrying Out a Self-Inspection
• Report prepared at completion of inspection, including:
 Results
 Evaluation
 Conclusions
 Recommended corrective measures

• Follow-up action
 Effective follow-up programme
 Company management to evaluate both
the report and corrective actions
Inspeksi diri = Audit Internal
• Inspeksi diri dan/atau audit mutu yang secara
berkala mengevaluasi efektivitas dan
penerapan sistem Pemastian Mutu

• Hendaklah tersedia prosedur manajemen

untuk manajemen yang sedang berlangsung
dan pengkajian aktivitas serta efektivitas
prosedur tersebut yang diverifikasi pada saat
inspeksi diri.
 BAB 8
INSPEKSI DIRI, AUDIT MUTU DAN AUDIT & PERSETUJUAN
PEMASOK
CPBAOB= Cara Pembuatan Bahan Aktif Obat yang Baik