HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE SUPP

ARV MANAGEMENT
PROMOTING QUALITY MEDICINES

Tim Fasilitator Perawatan, Dukungan dan Pengobatan HIV/ART

Kementerian Kesehatan Republik Indonesia
Direktorat Jenderal Pengendalian Penyakit dan Penyehatan Lingkungan
2014
HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE HIV
PROMOTING QUALITY MEDICINES PROCESS
- WHO PQ
- GMP Compliance
- BE (GLP, GCP)

SAMPLING &
TESTING

- GMP Compliance
- BE (GLP, GCP)

PHARMACIST ON ARV SITE

PROMOTING QUALITY ARV through:
- GOOD STORAGE
- EDUCATE NURSE,
PATIENT, WAREHOUSE
ON PQM
- VISUAL INSPECTION
HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE HIV
GOOD STORAGE

- Suhu penyimpanan Sesuai dengan

Petunjuk Penyimpanan pada kemasan
- Kelembaban
- Sistem FEFO
- Terlindung dari sinar matahari
langsung

di Materi ARV Management

(Management Logistik ARV)
HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE HIV
Visual Inspection of Labels

Visual inspection covers the

description of the packaging and
labels as well as the description of
dosage forms
 INSPEKSI VISUAL untuk Kemasan Produk Obat yang memenuhi Standard GMP
HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE HIV

The drugs strength

Company (important-primary
Trade name
logo to prescriber)

The
Dosage form
drugs Indicating
scientific The route of
name administration

The number
of units per
container

Storage Batch number

Condition Manufacturing
data

The
manufacturers Expiry date -
full address stability
HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE HIV
Visual Inspection of Tablets
HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE HIV

Visual Inspection of Tablets

Tablet diameter is unique to each individual

product. That provides a helpful means for
identification purposes.

Diameter of tablets presented in a circular shape

can vary between 5.0 and 15.0 mm.
Visual Inspection of Capsules
HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE HIV

Visual

Forms
Solid Dosage
Inspection of
HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE HIV

FISIK
FORM HASIL
PEMERIKSAAN
HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE HIV
Visual Inspection Labels
Visual Inspection Labels

Brand name : Quinine

Sulphate 300 mg
I.N.N. : Quinine Sulphate
Size : 1000 tablets
Lot No. : 20530
Reg. No. : 2A 2410/28
Mfg. date : 10.03.02
Exp. date : 10.03.06
Source : Brainy
Pharmaceutical
Visual Inspection Labels

Brand name: Chloramphenicol

I.N.N. : Chloramphenicol
Size : 1000 tablets
Lot No. : Unknown
Reg. No . : Unknown
Mfg. date : 09-01-03
Exp. date : 09-01-07
Manufacturer : Brainy Pharmaceutical
Visual Inspection Labels

Brand name :
Tetracycline 1%
I.N.N. : Tetracycline
Size : 1 tube/box
Lot No. : 15801
Mfg. date : 12.12.02
Exp. date : 12.04
Source: : Unknown
Visual Inspection Labels

Brand name : Dexamethasone

0.5 mg
I.N.N. : Dexamethasone
Size : 1000 tablets
Lot No. : 541
Reg. No. : 1A543/44
Mfg. date : 07.04.03
Exp. date : 07.04.08
Source : A Pharma. Laprao
Rd. Bangkok, Thailand
Visual Inspection Labels
Brand name : Spectrim
I.N.N. :
Sulfamethoxazole and
Trimethoprim
Size : 1000 tablets
Lot No. : 01879
Reg. No. : Unknown
Mfg. date : 30.06.2002
Exp. date : 30.06.2006
Visual Inspection Labels
Visual Inspection Uniformity of Size
HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE HIV
Visual Inspection Uniformity of Color
HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE HIV
Visual inspection summary

Inspection of packaging material

Strong Odor
Excessive moisture uptake (fusion or stickiness of
tablets and capsules)
Inspection of Labels
Presence of durable label
Label should provide all required information
Inspection of Dosage Forms
Signs of defects (blemishes, dirty marks or sports,
abrasion, cracks, fusion or swelling etc)
HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE HIV
EDUKASI WAREHOUSE/PERAWAT/PASIEN TTG PQM

WAREHOUSE PERAWAT PASIEN

- Good storage
- Visual
Inspection - Visual
Inspection
 COUNTERFEIT &
SUBSTANDARD MEDICINE

HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE SUPP
 THANK YOU

HIV ART CARE SUPPORT AND TREATMENT HIV ART CARE SUPPORT HIV ART CARE SUPP