PENYIMPANAN OBAT

Oleh: Asset At Taqwa

Tujuan Pembelajaran
• Memahami cara penyimpanan obat yang
baik di industri farmasi
Apakah Anda masih ingat materi tentang Produksi dan
Rantai Pasokan?
Incoming Dispensing Manufacturing Packaging Shipment

Storage after Storage after Storage after Storage after

process process process process
Location Location
Warehouse Location Location
Production
Production Production
Type Type
- Raw material Type Type
- Packed material
- Packaging material Dispensed material Bulk material
- FGs
- Bulk/ Intermediate
- Consumable Location
- Etc. Location
Warehouse Warehouse

Material Status Type

- Quarantine Type
Returned material - Returned material
- Released from production
- Rejected from production
- FGs
Good Storage Practices
That part of quality assurance that ensures that the quality of
pharmaceutical products is maintained by means of adequate control
throughout the storage thereof

- Storage in Warehouse
- Storage in Production

Istilah CPOB
Cara Penyimpanan yang Baik
General Purpose
To prevent mix up, contamination & cross-contamination

To protect the materials in controlled storage condition (i.e.

temperature, RH, etc.)

To ease the inventory control & material handling

To protect goods from pest

  All materials and FGs must be labeled properly and
separated physically
 Rejected materials/ FGs, returned FGs, controlled
substances (i.e. narcotics, precursors) must be stored
General Rule separately in locked storage area
 Printed materials must be stored in restricted storage
area, labels for FGs must be stored in locked storage
area
 It contains below information:
- Name of material or goods
- Batch or lot number
- Quantity of material or goods
Label for
- Storage conditional, if required
Identification
- Manufacturing date and expiry date, if required
- Status of material/ goods (quarantine/ released/ reject/
work in process, etc.)
Hundreds, thousands, or even millions of materials & FGs are stored in
warehouse at the same time
Incoming Dispensing Manufacturing Packaging Shipment

Storage after Storage after Storage after Storage after

process process process process
Location Location
Location
Warehouse Warehouse
Warehouse
Type Type
Type
- Raw material - Returned material
Returned material
- Packaging material from production
from production
- Bulk/ Intermediate - FGs
- Consumable
- Etc.

Material Status
- Quarantine
- Released
- Rejected
Storage in Warehouse

Lighting

Unique ID in
each bin

Labeled material

Space for
Locked cage
material
handling
- Temperature and RH is monitored, depends on material characteristic
- Cleaning procedure is in place
- Pest control is in place
 The determination of
inventory quantity by
actual count. Physical
inventories can be taken
on a continuous,
periodic, or annual basis

Imagine the way how

we count materials, if a
Inventory Control million exists
Incoming Dispensing Manufacturing Packaging Shipment

Storage after Storage after Storage after Storage after

process process process process

Location
Location Location
Production
Production Production
Type
Type Type
- Packed material
Dispensed material Bulk material
- FGs
Storage in Production
Lighting

Labeled material

- Cleaning procedure
is in place
- Pest control is in
place

Space for material handling

Storage in Production
Viable
Temperature - Settling Plate
- Contact Plate
- Air Sampler
Relative Humidity
Non Viable
- Particle Count
Viable & Non Viable
Differential Pressure
Differential Pressure - Air Flow
- Air Change Rate
Type of Room
- Production process room
- Equipment storage room
- Bulk storage room
Differential Pressure
 Yield
The amount of goods or
Input Process Output acceptable material
available after the
completion of a process

Reconciliation
The process of counting
yield, material usage,
rejected material, and
%variance
Yield and Reconciliation