ASSIGNMENT

PROBLEM BASED LEARNING (PBL)

BUILDING AND FACILITY

GROUP 1 :
1. ZAHROH NUR LAILY 1808062161
1. NADYA AMALIA 1808062162
2. NOVIA ARIANI DEWI 1808062163
3. AKMAL MAULANA 1808062164
4. ASPRILLA RESTU S.W 1808062181
5. RISKA SYAFRITA NINGSIH 1808062188
6. MESRI WINDA 1808062190
7. IMA YUSHEILA C.D.D 1808062204
8. NURRAHMI 1808062210

CLASS : B
LECTURER : DEASY VANDA PERTIWI,M.Sc.,Apt

PHARMACIST PROGRAM XXXVII

FACULTY OF PHARMACY
AHMAD DAHLAN UNIVERSITY
YOGYAKARTA
2019

SCENARIO
Building and Facility
 Materials layout in finished product storage and material storage based on output
system (FEFO system), during the visiting in product storage discovered:
1. There is return product, 1 palet placed on quarantine area and labeled as return
product
2. Used to store finished product and suplement, bottle packaging materials, medical
device and retain sample
3. Temperature and humudity checked manually once in three days according the
operational standard (SOP)

POINT OF CPOB
Chapter 3 Building and Facilities - Storage Area
3.28 Area penyimpanan hendaklah memiliki kapasitas yang memadai untuk
menyimpan denganrapi dan teratur berbagai macam bahan dan produk seperti bahan
awal dan bahan pengemas, produk antara, produk ruahan dan produk jadi, produk
dalam status karantina, produk yang telah diluluskan, produk yang ditolak, produk
yang dikembalikan atau produk yang ditarik dari peredaran.

3.28 The storage area should have sufficient capasity to store materials neatly and
regulary. Materials stored in the storage area including : starting and packaging
materials, intermediet product, bulk products, rejecting product and returned product

3.29 Area penyimpanan hendaklah didesain atau disesuaikan untuk menjamin kondisi
penyimpanan yang baik; Secara khusus area tersebut hendaklah bersih, kering dan
mendapat pencahayaan yang cukup serta suhunya dipertahankan dalam batas yang
ditetapkan.

3.29 Storage area should be desaigned or adjusted to prove good storage conditions.
The area should be clean, dry, and get enough lightiing also the temperature should
be maintained.

3.30 Apabila kondisi penyimpanan khusus (misal suhu, kelembaban) dibutuhkan,

kondisi tersebut hendaklah disiapkan, dikendalikan, dipantau dan dicatat di mana
diperlukan.

3.30 Special storage (eg. Temperature, humidity), the conditions should be prepared,
controlled, monitored and recorded when needed.

3.32 Apabila status karantina dijamin dengan cara penyimpanan di area terpisah,
maka area tersebut hendaklah diberi penandaan yang jelas dan akses ke area tersebut
terbatas bagi personel yang berwenang. Sistem lain untuk menggantikan sistem
karantina barang secara fisik hendaklah memberi pengamanan yang setara.

3.32 If quarantine status is guaranteed by storage in the seperate area, the area
should be cleared labeled and access to the area is limited to authorized personnel.
Another system to replace quarantine system physically should be equal.

3.34 Area terpisah dan terkunci hendaklah disediakan untuk penyimpanan bahan dan
produk yang ditolak, atau yang ditarik kembali atau yang dikembalikan.

3.34 There's should be any different and locked area to store materials and product
that rejected or withdrawn or returned product.

Chapter 5 Production
Material and Dry Products
5.99 Cangkang kapsul hendaklah diperlakukan sebagai bahan awal. Cangkang kapsul
hendaklah disimpan dalam kondisi yang dapat mencegah kekeringan dan kerapuhan
atau efek lain yang disebabkan oleh kelembaban.
5.99 Capsule shell should be treated as starting materials. Store in a place that can
prevent to drought and friability or others effect caused by humidity

Starting materials and Packaging materials

5.199 Pemisahan secara fisik atau cara lain yang tervalidasi (misalnya cara elektronis)
hendaklah disediakan untuk penyimpanan bahan atau produk yang ditolak,
kedaluwarsa, ditarik dari peredaran atau kembalian. Bahan atau produk, dan area
penyimpanan tersebut hendaklah diberi identitas yang tepat.

5.199 Physical separation or other validated method ( eg electronic method) should

be provided to store materials or rejected products, expired, withdrawned or returned.
Materials or product, and storage area should be given right identity.

Rejected, Recovered, Returned Materalias and Product

5.167 Bahan dan produk yang ditolak hendaklah diberi penandaan yang jelas dan
disimpan terpisah di “area terlarang” (restricted area). Bahan atau produk tersebut
hendaklah dikembalikan kepada pemasoknya atau, bila dianggap perlu, diolah ulang
atau dimusnahkan. Langkah apa pun yang diambil hendaklah lebih dulu disetujui oleh
kepala bagian Manajemen Mutu (Pemastian Mutu) dan dicatat.

5.167 rejected materials and product should be labeled clearly and store separately in
the “restricted area”. Materials or product should returned tosupplier if necessary,
reprocessed or destroyed. Every steps taken should be approved by the head of
Management Quality (Quality Assurance) and recorded.

Equipments
37. Apabila suhu penyimpanan terkendali dipersyaratkan, lingkungan hendaklah
dikendalikan, dipantau dan dicatat dengan tindakan sebagai berikut:
  Hendaklah tersedia alat pencatat suhu, dan catatannya hendaklah
dikaji secara teratur;
 Di mana diperlukan, hendaklah dipasang alarm dan/atau alat
peringatan audio-visual yang mengindikasikan bahwa sistem pengendali
suhu penyimpanan telah mengalami kegagalan. Sistem ini hendaklah
mengijinkan penyetelan ulang hanya kepada personel yang diberi
wewenang, dan dicek secara teratur dalam jangka waktu yang
ditetapkan;
 Lemari pendingin (refrigerator) dan lemari pembeku (freezer) hendaklah
dibebaskan dari es secara teratur dan dibersihkan; dan
 Apabila fasilitas penyimpanan dingin dimatikan, pembersihan total
hendaklah dilakukan.

37. If The temperature of storage should be controlled, the enviroment should be

controlled, monitored and recorded with actions required bellows:
 Thermometer or temperature recorder should be available, and should be
reguraly reviewed
 If necessary, alarms and/or audio visual tools that indicates the temperature
of storage has failed should be installed. This system should only allow the
personel that given authority to do resetting, and checked regulary within a
periode of time set
 The ice should be be cleaned from refrigerator and freezer regulary
 If the cold storage facility is turned off, total cleaning should be done

WAREHOUSE DESIGN
 DISCUSSION AND CONCLUSION
A. Discussion
Based on this case there is found three problems, first is return product placed in
quarantine area,second problem is packaging materials, finished product, medical
device and retained sample placed in the same area, the third problem is temperature
and humidity not checked regulary. We assumed that the root problem from this case
is there is no standard operation (SOP) for storage. The things that we need to do to
resolve this case are:
Problem 1 : Returned product placed in quarantine 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 according to CPOB
4. Do corrective action : Separate between quarantined product and returned product
5. Do preventive action : Make SOP for storage according to CPOB
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 : Separate between Packaging materials, finished prduct,
medical devices and retained sample
5. Do preventive action : Make SOP for storage accordance to CPOB
Problem 3 : Temperature and humidity not be checked regulary
1. Storage’s supervisor make DVR to QA
2. QA do investigation of the root problem
3. The root problem is on the method, the standard operational (SOP) for storage
didn’t accordance to CPOB
4. Do corrective action : Checked temperature and humidity regulary
5. Do preventive action : Change the SOP for storage according to CPOB
6. Makes Change control

B. Conclusion
This case is catagorized as mayor and critical case, corrective and preventive
action should be done. Several documents like Handling Deviation Protocol (Protap
penanganan penyimpangan), Deviation handling (Penanganan penyimpangan), and
Change control (Pengendalian Perubahan) are needed.
 Appendix 1.2k.2
Problem 1 & 2
Form I
REPORT OF DEVIATION AND ACTIONS THAT HAVE BEEN TAKEN
Deviation number 001
Product name /Process /Inspection 1. Return product stored in quarantine
/System /Equipment*) room
2. Separated storage area for packaging
material, finished product, medical
device and retained sample
Batch number
Dates of irregularities February 14th 2019
Detail of irregularities
1. There is mixed products in the warehouse/storage, the return product placed in the
quarantine area (problem 1)
2. There is no operation standard (SOP) that comply with CPOB regulations that cause
mixed product in warehouse (problem 1)
3. There is mixed products in the warehouse such as packaging material, finished product,
medical device and retained sample (problem 2)
4. There is no SOP that comply with GMP regulations that cause mixed product in
warehouse (problem 2)
Detail of temporary action taken :
1. Move the return product from quarantine area to restricted area (problem 1).
2. Separated all product with different area to minimize of cross contamination/mix-up
(problem 2)
Risk to drug’s quality, safety, and effectivity:
Critical: Major: Minor:
Problem 1 Problem 1
If the return product is placed  Storage of products that do
in a quarantine room and the not comply with the rules
personnel does not know that can cause mixing which can
the product is a return product, affect the quality of other
it can cause the product that products.
has to be destroyed to be tested Problem 2
again.  If all product mixed in same
room it can caused cross
contamination and affect to
quality of product.
 There is no SOP for
specification of storage room

Note:
The process must be stopped until further action is established and approved
Are there any batches or other products that Yes No
are affected?
Explain if yes
Other materials or products can be contaminated / reduce the quality of other products.

Reporter
Name : Zahroh Nur Laily Signature : Date : February 14th 2019
Head of Section (from Relevant Departments / Units)
Name : Nurrahmi Signature : Date : February 14th 2019
Evaluation of reports, actions and risks:
A check must be made first whether there is a deviation, then after the report received and
followed up by moving the return product from quarantine room to restricted area.
Head of QA Section
Name : Akmal Maulana Signature : Date : February 14th 2019
Types of deviation : Risk level :
√ Batchs √ Critical
Nonbatchs √ Major
Minor
Notes
 Form II
DEVIATION INVESTIGATION
Deviation number 001
Date February 14th 2019
Investigation
What happened :
1. There is a return product that placed in the quarantine area.
2. There are many kind of product in the same area
What is distorted:
1. Storage’s arrangement is not in accordance with existing regulations, there is mixed product
in the warehouse.
Who was involved:
1. Storage’s supervisor
2. Head of the warehouse section
Why do these deviations arise:
1. There is no SOP regarding the product’s storage that are in accordance with GMP
2. Storage’s arrangement is not in accordance with existing regulations, there is mixed product
in the warehouse.

Conclusion of deviation’s problem:

1. Method (absence of SOP)

Proposed Corrective Action and Preventive Action (CAPA) to be carried out

Action Person in charge Time Sign and date
1. Moving the return Storage Manager Right after February 14th 2019
product from audit
quarantine room to
restricted area.
2. Separated product in
different area

3. Make storage’s QA Manager Right after February 14th 2019

SOP according to audit
CPOB

Supported Document : Needed

Not Required
Examined by/Date: February 14th 2019 Approved by:
Head of Storage Section Head of QualityAssurance

Nurrahmi Akmal Maulana

Form III
AUTHORIZTION OF HANDLING CORRECTIVE ACTION AND DEVIATION
Diviation number 001
Date February 14th 2019
Corrective action :
1. Moving the return product from quarantine room to restricted area (problem 1).
2. Separated product in different area base on the kind of product with CPOB and POPP
(attachment of 3.29 for warehouse design) (problem 2).
Person in charge : Finish date

Nurrahmi February 14th 2019

Storage Supervisor
Preventive action :
Make storage’s SOP according to CPOB

Conclusion: There is a deviation in the return product, the product is placed in the quarantine
area and the product mixed up in same area . The corrective action is moving the return product from
the quarantine room to a restricted area and separated in deifferent area. The preventive action
by making a SOP for storage in accordance with CPOB.

Deviations have been followed up by the Warehouse Dept. and corrective and preventive actions
have been completed.

Yogyakarta, February 14th 2019

 Checked by Approved by

Nurrahmi Akmal Maulana

Head of Storage Section Head of Quality Assurance Section
Problem 3

Form I
REPORT OF DEVIATION AND ACTIONS THAT HAVE BEEN TAKEN
Deviation number 002
Product name /Process /Inspection /System /Equipment*) Change of SOP for
storage area (temperature
and humidity)
Batch number
Dates of irregularities February 14th 2019
Detail of irregularities that occur
1. The temperature and humidity not be checked regulary
2. There is SOP that not suitable with GMP regulations

Detail of temporary action taken :

1. Checked temperature and humidity regulary
2. Change the SOP according to CPOB

Risk to drug’s quality, safety, and effectivity:

Critical: Major: Minor:
The temperature and humidity is critical
parameter for storage, if there are not
checked regulary it will affect in
stability and quality of the product
Note:
The process must be stopped until further action is established and approved

Are there any batches or other products that are affected? Yes No

Explain if yes
if the temperature and humidity not checked regulary it will affect in stability and quality of the
product

Reporter
Name : Zahroh Nur Laily Signature Date: February 14th
: 2019
Head of Section (from Relevant Departments / Units)
Name : Nurrahmi Signature Date: February 14th
: 2019
Evaluation of reports, actions and risks:
A check must be made first whether there is a deviation, then after the report received and
followed up by make change of SOP according to CPOB
Head of QA Section
Name : Akmal Maulana Signature Date: February 13th
: 2019
Types of deviation : Risk level :
Batchs √ Critical
√ Nonbatchs Major
Minor
Note
 Form II
DEVIATION INVESTIGATION
Deviation number 002
Date February 14th 2019
Investigation
What happened :
There is mixed products in the warehouse, finished product and supplements, bottle packaging
materials, medical device and retain sample stored in the same place.

What is distorted:
Storage’s arrangement is not in accordance with existing regulations, there is mixed product in
the warehouse.

Who was involved:

1. Storage’s supervisor
2. Head of the warehouse section

Why do these deviations arise:

1. There is no SOP regarding product storage in accordance with CPOB and product layout
does not match POPP

Conclusion of deviation’s problem:

1. Method (absence of SOP)

Proposed Corrective Action and Preventive Action (CAPA) to be carried out

Action Person in charge Time Sign and date

1. Separate the finished Storage Manager Directly after February 14th 2019
product and supplements, audit
bottle packaging materials,
medical device and retain
sample

2. Make storage’s SOP QA Manager Directly after February 14th 2019

according to CPOB audit
3. Make warehouse layout Storage Manager Directly after February 14th 2019
and then arranging the audit
finished product and
 supplements, bottle
packaging materials,
medical device and retain
sample barang menurut
PPOP

Supported Document : Needed

Not Required
Examined by/Date: February 14th 2019 Approved by:
Head of Storage Section Head of Quality Assurance

Nurrahmi Akmal Maulana

 Form III
AUTHORIZTION OF HANDLING CORRECTIVE ACTION AND DEVIATION
Diviation number 002
Date February 14th 2019
Corrective action :
Checked temperature and humidity regulary

Person in charge : Finish date

Nurrahmi February 14th 2019

Storage Supervisor
Preventive action :
Make change of SOP according to CPOB

Conclusion: There is a deviation in the warehouse, to prevent the deviation in the future, make
change of SOP according to CPOB

Deviations have been followed up by the Warehouse Dept. and corrective and preventive actions have
been completed.

Yogyakarta, February 14th 2019

Checked by Approved by

Nurrahmi
Akmal Maulana
Head of Storage Section
Head of Quality Assurance Section
 Appendix 1.2I
FORM I
CHANGE CONTROL FORM
Deviation Number 002
Nama Produk /Proses /Pemeriksaan Change of SOP storage area (temperature and
/Sistem /Alat /Dokumen) humidity)
Suggesion by Head of Storage Section
KIND OF DEVIATION
Process/Method √ Document
Material/Product Stability
√ Facility/tool Device
Description/ detail description : Do change of SOP setting/monitoring temperature storage area.

Reason of change : Monitoring temperature and humidity is a critical point who can affect
stability drug material so it affect quality of drug.
Estimate of cost : Attached
When the change will be doing : 28th February 2019
Suggesion by:
Nama : Nurrahmi Signature : Date : 14th February 2019
(supervisior of storage)
Head of Quality Assurance Section :

Nama : Akmal Maulana Signature : Tanggal : 14th February 2019

Assessment

Assassement (TT) : Date : Conception

Head of Quality Control 16th Februariy 2019 Suggesion accepted

Section
Head of Production Section
Head of Technique Section
Head of Development Section
Head of Logistic Section
Suggesion accepted/ decline *) by :
Head of Quality Assurance
Section:
16th Februariy 2019
th
16 Februariy 2019
16th Februariy 2019
16th Februariy 2019
Signature :
Suggesion accepted
Suggesion accepted
Suggesion accepted
Suggesion accepted
Date :
18th February 2019
 FORM II
CHECKLIST OF PREPARATION FOR CHANGE
Number of Change Control : 002
*)
Name/Product/Process/Inspection/System/Equipment : SOP changes in storage
space (temperature and
humidity)
Changes can be directly carried out without waiting for permission from the POM
because:
√ Notification will be submitted along with document changes
concerned by the Registration Department in stages

No change notification required

Changes require POM Agency permission first

Changes cannot be made before POM Agency approval is received.
Notification of changes will be reported by:

(Nurrahmi)
(14 Februari 2019)
Changes have been approved by the date POM Agency:
Documents that need to be revised / prepared in connection with the plan
changes that will be made:
Document type No Need Need No. Doc. / Date.
Processing / Packaging √
Procedure
Main √ 001/14 February
2019
Specification √ 002/14 February
2019
Analysis Method √
Validation of Analysis Methods √
Process Validation √ 003/14 February
2019
Stability observation √ 004/14 February
2019
Qualification Reports √
Other systems affected by change:
 FORM III
AUTHORIZATION ENFORCEMENT CHANGES
Deviation number : 002
Detail deviation action taken:
Change of SOP in storage area ( controlling temperature and humidity which affect in
stability ang quality of product)according to CPOB.
Detail of temporary action taken by : Head of Storage Section
Name Signature Date

14th February 2019

Nurrahmi
Other related department :
Name Signature Date

Zahroh Nur Laily 18th February 2019

Conclusion :
Signed below stated that all aspects relating to a change of the applicable procedure accordingly
met and stated that all necessary paperwork has been completed is prepared and all the systems
that are affected by the changes have been adjusted and all have met the criteria that apply

Yogyakarta, 18 Februari 2019

Checked by : Approved by :

Nurrahmi Akmal Maulana

Head of Storage Section Head of Quality Assurance Section
 PROTOCOL OF PRODUCT STORAGE

PT. Protocol Page 1 of 2

INTERNATIONAL PRODUCT STORAGE
FARMA No 002 Applied date
Warehouse Departement Storage Section February 14th 2019

Arranged by : Checked by : Approved by :

Zahroh Nur Laily Akmal Maulana
Nurrahmi
(Head of Quality Assurance)
(SPV Penyimpanan) (Head of Warehouse) Date
Date Date Date
Februari 14th 2019
Februari 14th 2019 Februari 14th 2019 Februari 14th 2019

General
Storage area should have sufficient capasity to store materials neatly and regulary
The materials include i.e. starting and packaging materials, intermediet product and
bulk product, rejected product and returned product
Storage are should be designed or adjusted to prove good storage conditions. Maintain
the cleanness, humidity, lighting, and temperature
Quarantine area should be prepared in different area and have to be locked to store
materials and products which are rejected or withdrawn or returned product
Storage operations should be adequately segragated from other operations

Starting and packaging materials

Materials or products should be appropriately identified
Check the identity, condition of container and approval of Quality Control Unit, if its
not comply with the requirements, the container should be delivered to the quarantine
area
Separate the starting materials to packaging materials in different line
Materials should be stored in orderly manner, each materials should be arranged in a
row based on FEFO system
Materials should be stored off the floor and sufficiently spaced
Highly active materials and radioactive materials, narcotics, other dangerous drugs, and
substances presenting special risk of abuse, fire or explosion should be stored in safe
and secure areas, separated from the others materials
Narcotics and other dangerous drugs should be stored under lock
Printed packaging materials should be stored under lock in a restrictive storage area
Temperature and humidity monitors should be located in areas that are most likely to
show fluctuation
 PT. Protocol Page 2 of 2
INTERNATIONAL PRODUCT STORAGE
FARMA No 002 Applied date
Warehouse Departement Storage Section February 14th 2019

Arranged by : Checked by : Approved by :

Zahroh Nur Laily Akmal Maulana
Nurrahmi
(Head of Quality Assurance)
(Storage SPV) (Head of Warehouse) Date
Date Date Date
Februari 14th 2019
Februari 14th 2019 Februari 14th 2019 Februari 14th 2019

Intermediate product, bulk product, and finished product

Each product should be a system describing the details of the batch and lot numbering
Each batch of the products (intermediate, bulk or finished products) stored in
storage areas should have an inventory card
All of the products should be properly labelled
Each prodcut should be separate based on caterogy (intermediate/bulk/finished) in
different line
All of the products should be kept under appropriate conditions
If the identity or condition of intermediate or bulk product does not comly with the
requirements of identity or condition, that should be retained in the quarantine for
Quality Control inspection and disposition
Temperature and humidity monitors should be located in areas that are most likely to
show fluctuation

Rejected, Recovered, Returned Material and Product

All materials and products returned to storage areas should be properly documented and
reconciled
Rejected materials and products should be properly labelled
Store the materials and products separately in the restricted area