ARV

MANAGEMENT
P R O M O T I N G T H E Q U A L I T Y O F M E D I C I N E S

PRESENTED BY:
YENNY TJU
WHY DO WE NEED QUALITY ASSURANCE
Because counterfeit and substandard drugs
are widely produced and available and are :
- A constant threat to global health,
especially for people living in countries with
limited regulatory capacity and resources
- PuFng the public at risk from unsafe and
ineecIve medicines
- Causing resistant problem for ATM
medicines such as TB/ARV
- Regulator as countries receive GF fund : QA
medicines mandatory since 2009, QA lab
diagnosIc mandatory since 2011
 INTRODUCTION TO QUALITY
ASSURANCE (QA) SYSTEM
- Quality Assurance is dierent with Quality Control
- Quality Assurance is not just laboratory tesIng
- Laboratory tesIng alone can NEVER provide an
eecIve QA system
- Four category for QA : Procurement, LogisIc,
storage and DistribuIon
 STEPS to Assure Product Quality

Assured drug quality

DocumentaGon, TesGng, monitoring and evaluaGon
Pre-markeIng Technical Regulatory Post-markeIng
quality elements framework authorizaIon
assessment (quality (central surveilance (for
(markeIng specicaIons, administraIon,r quality tesIng
authorizaIon, basic test, GMP, egistraIon , and adverse
licensing, and GLP, GDP inspecIon and events)
registraIon) gov lab Services

GMP=Good Manufacturing Prac1ces; GDP= Distribu1on ; GLP = Laboratory

 QUALITY ASSURANCE COST

Procedures Cost EecGveness

Verify documents $1 30%
Visual InspecIon $2 40%
Sampling $5

Screening test (Mini Lab) $20 80%

Basic Lab Test $1,000 98%

Full Assay Pharmacopeia $10,000 99,9%

 Cara menentukan produk yang akan difokus
Menentukan produk-produk untuk fokus kontrol
kualitas dengan
- Kombinasi VEN (Vital-Essensial-Non Essen1al) dan ABC
pareto (20%: 80%)
- NTI (narrow TherapeuIc Window), cth: Efavirenz
- Produk yang bermasalah dengan Bioavailability
- Modied-release preparaIon
- Stability problem : misal sediaan sirup parasetamol akan lebih
prioritas daripada tablet parasetamol karena sedian dalam bentuk sirup lebih
kurang stabil dari tablet.

 Percentage of batches to send for
quality tesGng
No Product Category %
A Drugs supplied from a WHO prequalied source 5

B Drugs supplied from a SRA(Solicitors RegulaIon 5

Authority) approved source
C Source and products with GMP cerIcates but not 10
prequalifed WHO
D Sources without GMP cerIcates 50

E ACT (Adenylate Cyclase Toxin) and other temperature 10-50

sensiIve products
F First line anI HIV, TB and malaria Drugs 10

G Products with past and documented quality issues 100

H First IntroducIon in the country of desInaIon 50

 Number of units or size of sample per
pharmaceutical form

Nr Pharmaceutical form Units

1 Tablets, capsules, oral powder 100
2 Powder for injection 40
3 Ampoules and small volume vials 40
4 Eye drops, creams 10
5 IV solutions 5
6 Syrup, suspension or oral solution 10
7 Sterility tests and endotoxins 10
DOCUMENT THAT NEEDED FOR QA
 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
 GOOD STORAGE
- Suhu penyimpanan Sesuai dengan
Petunjuk Penyimpanan pada kemasan
- Kelembaban
- Sistem FEFO
- Terlindung dari sinar matahari
langsung

di Materi ARV Management

(Management LogisGk ARV)
 Visual InspecGon of Labels

Visual inspecGon covers the

descripGon of the packaging and
labels as well as the descripGon of
dosage forms
 INSPEKSI VISUAL untuk Kemasan Produk Obat yang memenuhi Standard GMP

The drugs strength

Company (important-primary
Trade name
logo to prescriber)

The
Dosage form
drugs IndicaGng
scienGc The route of
name administraGon

The number
of units per
container

Storage Batch number

CondiGon Manufacturing
data

The
manufacturers Expiry date -
full address stability
Visual InspecGon of Tablets
VISUAL INSPECTION OF TABLETS

Tablet diameter is unique to each individual

product. That provides a helpful means for
idenIcaIon purposes.

Diameter of tablets presented in a circular shape
can vary between 5.0 and 15.0 mm.

VISUAL INSPECTION OF CAPSULES

VISUAL
INSPECTION
OF SOLID
DOSAGE
FORMS


FORM HASIL
PEMERIKSAAN
FISIK
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
VISUAL INSPECTION UNIFORMITY
OF COLOR
 VISUAL INSPECTION SUMMARY
InspecIon of packaging material
Strong Odor
Excessive moisture uptake (fusion or sIckiness of tablets and
capsules)
InspecIon of Labels
Presence of durable label
Label should provide all required informaIon
InspecIon of Dosage Forms
Signs of defects (blemishes, dirty marks or sports, abrasion,
cracks, fusion or swelling etc)
 EDUKASI WAREHOUSE/ PERAWAT/
PASIEN

Warehouse Perawat Pasien

Good Storage Visual Visual

GDP inspecIon inspecIon
TERIMA KASIH