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SCENARIO material, intermediate room for raw materials and room for intermediate

BUILDING AND FACILITY product, etc should be separated.

Materials layout in finished product storage and material storage Chapter 5 Production
based on output system (FEFO system), during the visiting in product Material and Dry Products
storage discovered: 5.99
1. There is return product, 1 pallet placed on quarantine area and labeled as Capsule shell should be treated as starting materials. Store in a place that
return product can prevent to drought and friability or others effect caused by humidity
2. Used to store finished product and supplements, bottle packaging Starting materials and Packaging materials
materials, medical device and retain sample 5.199
3. Temperature and humudity checked manually once in three days Physical separation or other validated method ( eg electronic method)
according the operational standard (SOP) should be provided to store materials or rejected products, expired,
withdrawned or returned. Materials or product, and storage area should be
given right identity.
POINT OF CPOB, PPOB,
Problem 1 Rejected, Recovered, Returned Materalias and Product
Chapter 3 Building and Facilities - Storage Area 5.167
3.28 rejected materials and product should be labeled clearly and store separately
The storage area should have sufficient capasity to store materials neatly in the “restricted area”. Materials or product should returned tosupplier if
and regulary. Materials stored in the storage area including : starting and necessary, reprocessed or destroyed. Every steps taken should be approved
packaging materials, intermediet product, bulk products, rejecting product by the head of Management Quality (Quality Assurance) and recorded.
and returned product Problem 3
3.32 3.29
If quarantine status is guaranteed by storage in the seperate area, the area Storage area should be desaigned or adjusted to prove good storage
should be cleared labeled and access to the area is limited to authorized conditions. The area should be clean, dry, and get enough lightiing also the
personnel. Another system to replace quarantine system physically should temperature should be maintained.
be equal. 3.30
3.34 Special storage (eg. Temperature, humidity), the conditions should be
There's should be any different and locked area to store materials and prepared, controlled, monitored and recorded when needed.
product that rejected or withdrawn or returned product. 5.194 :
3.35 Temperature monitoring data should be available for evaluation. The tools
High potential active ingredients and radioactive materials, narcotics, drugs used for monitoring should be checked at predetermined intervals and the
other dangerous, and substances or ingredients that contain high risk against results of the inspection should be recorded and stored. All monitoring
abuse, fire or explosion should be stored in an area that is guaranteed safety. records should be kept for a period of at least the same as the age of the
Narcotics and dangerous drugs others should be stored in a locked place. material or product in question plus 1 year, or in accordance with
Problem 2 government regulations. Temperature mapping should be able to show
PPOP for warehouse design temperature according to specification limits in all areas of the storage
The design of warehouse should be in accordance with PPOB facility. It is recommended that the temperature monitor be placed in the
(attachment of 3.29 for warehouse design). The room for packaging area most often showing temperature fluctuations.
Equipments 5. Do preventive action (PA) : Make SOP for storage accordance to
37. CPOB, Storage’s personnel training.
If The temperature of storage should be controlled, the enviroment should Problem 3 : Temperature and humidity not be checked regulary
be controlled, monitored and recorded with actions required bellows: 1. Storage’s supervisor make DVR to QA
 Thermometer or temperature recorder should be available, and 2. QA do investigation of the root problem
should be reguraly reviewed 3. The root problem is on the method, the standard operational (SOP) for
 If necessary, alarms and/or audio visual tools that indicates the storage didn’t accordance to CPOB
temperature of storage has failed should be installed. This system 4. Do corrective action (CA) : Checked temperature and humidity
should only allow the personel that given authority to do resetting, regulary
and checked regulary within a periode of time set 5. Do preventive action (PA) : Change the SOP for storage according to
 The ice should be be cleaned from refrigerator and freezer regulary CPOB
 If the cold storage facility is turned off, total cleaning should be 6. Makes Change control
done

DISCUSSION CONCLUSION
Based on this case there is found three problems, first is return This case is catagorized as mayor and critical case, corrective and
product placed in quarantine area,second problem is packaging materials, preventive action should be done. Several documents like fixed procedure
finished product, medical device and retained sample placed in the same for handling aberration (Protap penanganan penyimpangan), Aberration
area, the third problem is temperature and humidity not checked regulary. handling (Penanganan penyimpangan), and Change control (Pengendalian
We assumed that the root problem from this case is there is no standard Perubahan) are needed.
operation (SOP) for storage. The things that we need to do to resolve this
case are:
Problem 1 : Returned product placed in quarantine area References:
1. Storage’s supervisor make DVR to QA Anonym, 2018, Cara Pembuatan Obat yang Baik, Badan Pengawas Obat
2. QA do investigation of the root problem dan Makanan RI : Jakarta.
3. The root problem is on the method, there’s no standard operational Anonym, 2014, Petunjuk Operasional Penerapan Pedoman Cara
(SOP) for storage according to CPOB Pembuatan Obat yang Baik Jilid I, Badan Pengawas Obat dan
4. Do corrective action (CA) : Separate between quarantined product and Makanan RI : Jakarta.
returned product
5. Do preventive action (PA) : Make SOP for storage according to
CPOB, Storage’s personnel training.
Problem 2 : Packaging materials, finished prduct, medical devices and
retained sample placed in the same area
1. Storage’s supervisor make DVR to QA
2. QA do investigation of the root problem
3. The root problem is on the method, there’s no standard operational
(SOP) for storage accordance to CPOB
4. Do corrective action (CA) : Separate between Packaging materials,
finished prduct, medical devices and retained sample

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