TUGAS CPOB

INSPEKSI DIRI DAN AUDIT MUTU

PT. OREVA

NAMA:

Kurniawati

(08121006001)

Rizki Arasyia

(08121006003)

Randi Hermawan

(08121006005)

Kosmalinda
Sefti Juwita

PROGRAM STUDI FARMASI

FAKULTAS MATEMATIKA DAN ILMU PENGETAHUAN ALAM
UNIVERSITAS SRIWIJAYA
2014/2015

Prosedur Tetap

Halaman 1 dari 4
No..

PT. OREVA
Departemen

INSPEKSI DIRI
Seksi

..

..

Disusun Oleh

Diperiksa Oleh

Disetujui Oleh

Tanggal

Tanggal..

Tanggal

Tanggal Berlaku.
..
Mengganti Nomor
.
Tanggal..

1. Tujuan
Inspeksi diri bertujuan untuk mengevaluasi seluruh sistem operasional perusahaan
dalam semua aspek yang dapat memengaruhi mutu produk. Inspeksi diri bukan hanya
untuk mencari kesalahan atau kelemahan yang ada tapi lebih utama untuk mencari cara
pencegahan dan mengatasi masalah secara efektif.
Protap ini bertujuan agar sistem inspeksi diri dapat:
mengevaluasi fasilitas produksi dan operasinya sudah sesuai dengan pedoman CPOB
dan menemukan kekurangan yang harus diperbaiki, dan
melaksanakan inspeksi diri secara teratur dan sistematis untuk mengevaluasi apakah
semua aspek dalam operasi produksi dan pengawasan mutu sudah memenuhi ketentuan
pedoman CPOB.
2. Ruang Lingkup
2.1 Protap ini berlaku pada saat penyiapan jadwal dan pelaksanaan Inspeksi Diri di Pabrik
.........
2.2 Inspeksi diri ini mencakup aspek-aspek sebagai berikut:
Personalia
- Produksi
Pengawasan Mutu - Keluhan dan Penarikan Kembali Produk
Dokumentasi
- Sanitasi dan Higiene
Bangunan
- Peralatan
3. Tanggung Jawab
3.1 Kepala Bagian Pemastian Mutu bersama dengan Tim Inspeksi Diri bertanggung jawab
merumuskan daftar periksa, mengkaji secara berkala dan menyesuaikan
3.2 Kepala Bagian Pemastian Mutu bertanggung jawab menyiapkan jadwal dan
menentukan Tim Inspeksi Diri
3.3 Tim Inspeksi Diri yang dipimpin oleh Kepala Tim bertanggung jawab untuk
pelaksanaan inspeksi diri.

Prosedur Tetap

Halaman 2 dari 4
No..

PT. OREVA
Departemen

INSPEKSI DIRI
Seksi

Disusun Oleh

..
Diperiksa Oleh

..
Disetujui Oleh

Tanggal

Tanggal..

Tanggal

Tanggal Berlaku.
..
Mengganti Nomor
.
Tanggal..

3.4 Kepala Tim bertanggung jawab menyiapkan laporan inspeksi diri dan rencana
perbaikan.
3.5 Pihak yang diinspeksi bertanggung jawab untuk menindak lanjuti dengan menyiapkan
rencana tindakan perbaikan dan pencegahan agar tidak terulang kembali, serta
menyelesaikan tindakan dalam kurun waktu yang sudah ditentukan.
4. Tim Inspeksi Diri :
Tim Inspeksi Diri harus terdiri dari personil yang berpengalaman minimal 3 tahun
mempunyai pengertian mendalam tentang CPOB, dilatih cara melaksanakan inspeksi diri
dan dikualifikasi.
Penanggung jawab : Kepala Bagian Pemastian Mutu
Anggota
: Manajer Pengawasan Mutu
Manajer Produksi
Staff senior Pemastian Mutu
Asisten Manajer Produksi
Inspeksi diri dilakukan minimal 2 orang dan maksimal 3 orang dari Tim Inspeksi Diri
5. Pembuatan Program
5.1 Pelaksanaan audit ditelusuri dari suatu program rencana audit tahunan yang
mengindikasikan bulan pelaksaan audit tiap bagian.
5.2 Audit dilaksanakan sesuai rencana, penyimpangan dicatat dan diberi alasan.
5.3 Audit mendadak dapat dilakukan, bila diperlukan, tanpa pemberitahuan.
6. Prosedur
6.1. Persiapan
6.1.1. Tentukan Tim yang akan melaksanakan inspeksi diri.
6.1.2. Siapkan daftar periksa.
Catatan : daftar periksa hanyalah sebagai panduan atau garis besar inspeksi diri,
kembangkan sesuai kondisi area yang diinspeksi.
6.1.3. Lakukan persiapan audit, pelajari
temuan dari inspeksi diri yang lalu serta tindak lanjutnya.
penyimpangan yang pernah didokumentasikan pada area yang akan diinspeksi.
kaji protap yang ada di area yang akan diaudit.
kaji dan sesuaikan checklist.
Prosedur Tetap

Halaman 3 dari 4

No..
PT. OREVA
Departemen

INSPEKSI DIRI
Seksi

Disusun Oleh

..
Diperiksa Oleh

..
Disetujui Oleh

Tanggal

Tanggal..

Tanggal

Tanggal Berlaku.
..
Mengganti Nomor
.
Tanggal..

6.2. Pelaksanaan :
6.2.1. Lakukan pemeriksaan dan catat temuan di lapangan.
6.2.2. Evaluasi penerapan CPOB dan Protap.
6.2.3. Diskusikan, kaji dan satukan semua temuan.
6.3. Buat laporan temuan pada Formulir Laporan Temuan ....... termasuk rekomendasi
perbaikan, bila mungkin.
6.4. Sampaikan laporan, diskusikan usulan perbaikan dan tindak lanjut dengan Kepala
Bagian yang terkait, serta tentukan batas waktu perbaikan.
6.5. Siapkan daftar dan rencana perbaikan dalam Formulir......
7. Pelaporan
Laporkan temuan dan tindak lanjut perbaikan serta batas waktu pada Kepala Bagian
terkait dan Direktur Pabrik.
8. Tindak Lanjut
8.1 Kepala seksi area terkait bertanggung jawab untuk menindak lanjuti rencana
perbaikan.
8.2 Tindakan perbaikan didokumentasikan, disetujui oleh Kepala bagian terkait dan
dilaporkan pada Tim Inspeksi Diri dan / atau Bagian Pemastian Mutu.
8.3 Untuk perbaikan yang belum dilaporkan penyelesaiannya pada batas waktu yang
disetujui:
8.3.1 Bagian Pengawasan Mutu mengingatkan Bagian terkait.
8.3.2 Bagian terkait wajib memberi penjelasan keterlambatan.
8.3.3Bagian Pemastian Mutu mengevaluasi dampak dari keterlambatan dan
melaporkan pada kepala Pabrik.
9. Lampiran

Program Inspeksi Diri *

Daftar Periksa Inspeksi Diri
Formulir Laporan Temuan Inspeksi Diri *
Formulir Tindakan Korektif dan Tindakan Preventif (CAPA) *
*Dalam Contoh ini tidak dilengkapi

Prosedur Tetap

Halaman 4 dari 4

No..
PT. OREVA
Departemen

INSPEKSI DIRI
Seksi

Tanggal Berlaku.
..

Disusun Oleh

..
Diperiksa Oleh

..
Disetujui Oleh

Tanggal

Tanggal..

Tanggal

Mengganti Nomor
.
Tanggal..

10. Dokumen Rujukan

10.1 Pedoman CPOB
10.2 ...........
11. Riwayat
VERSI NO
1
xxxxx
2
yyyyy

TANGGAL

ALASAN
Baru
Tambahan

12. Distribusi
Asli : Kepala Bagian Pemastian Mutu
Kopi No. 1: Kepala Bagian Pengawasan Mutu
No. 2: Kepala Bagian Produksi
No. 3: Kepala Bagian Teknik
No. 4.: kepala Bagian Logistik
No. 5: Direktur Pabrik

DAFTAR PERIKSA INSPEKSI DIRI

Bagian : Teknik dan Sistem Penunjang Kritis
Halaman 1 dari 5
1. Tanggal Inspeksi :

2. Tim Inspeksi
1 ________________________________
2 ________________________________
3 ________________________________
3. Tujuan Inspeksi :

Tanda tangan :
____________________
____________________
____________________

Note : Tingkat Kekritisan: C: Kritis; M: Mayor; m: Minor

Tingkat
No.
Daftar Periksa
Observasi
kekritisan
1
2
PERSONIL DAN
PELATIHAN
1.

Apakah ada pelatihan

karyawan terutama
mengenai CPOB dan
Protap

2.

Apakah ada Job description

untuk semua karyawan di
area ini

3.

Apa ada catatan pelatihan

bagi semua karyawan

4.

Apa ada program pelatihan

tahunan

5.

Apakah karyawan tampak

rapi, dan bersih termasuk
seragam dan sepatu

6.

Bagaimana pengetahuan
karyawan tentang Protap
yang ada

7.

PROTAP
Apakah ada protap
ditempat yang diperlukan

Komentar/Temuan

Beri tanda silang pada kotak yang sesuai , yakni :

1 = ya; 2 = tidak

Bagian : Teknik dan Sistem Penunjang Kritis

Halaman 2 dari 5
Tingkat
kekritisan

No.
8.

9.

10.

11.

12.

Daftar Periksa
Apakah protap dikaji dan
direvisi secara berkala
KEBERSIHAN DAN
SANITASI
Apakah karyawan tampak
bersih, rapi, mengenakan
seragam dan alat pelindung
dengan benar
Bagaimana kebersihan
area, dan pengisian
checklist pembersihan
untuk:
-bengkel
-gudang
-kantor
-ruang disel
-ruang boiler
PEMELIHARAAN
Apakah ada program,
jadwal dan catatan
pemeliharaan mesin
Apakah pemeliharaan
mesin selalu sesuai jadwal,
bagaimana melaporkan dan
menangani penundaan

13.

Apakah ada protap dan

spesifikasi pemeliharaan
berkala dari tiap mesin

14.

Apakah Protap
pengoperasian dan
pembersihan mesin
diletakkan pada mesin
terkait

Observasi
1
2

Komentar/Temuan

Bagian : Teknik dan Sistem Penunjang Kritis

Halaman 3 dari 5
Tingkat
kekritisan

No.

Daftar Periksa

15.

SISTEM TATA UDARA

Apakah Sistem Tata Udara

Observasi
1
2

Komentar/Temuan

sudah terkualifikasi dan

dilakukan kualifikasi
berkala
16.

17.

Bagaimana Protap
pemeliharaan Sistem Tata
Udara
Bagaimana program
pemantauan, perawatan,
pembersihan dan
penggantian filter

18

Apakah perawatan filter

udara dicatat

19.

Bagaimana pemantauan
berkala kebocoran
maupun hambatan filter

20.

21.

Bagaimana program
kalibrasi magnahelic pada
unit-unit penanganan
udara
SPA
Apakah program
pemantauan SPA
dilakukan secara
konsisten

22.
Bagaimana pencatat hasil
pemantauan pada buku
log SPA
23.
Apakah dilakukan
pengkajian terhadap hasil
pemantauan

Bagian : Teknik dan Sistem Penunjang Kritis

Halaman 4 dari 5

Tingkat
kekritisan

No.

Daftar Periksa

24.

Bagaimana program
pemeliharaan dan sanitasi
SPA

25.

Apakah program
pemeliharaan dan sanitasi
SPA dilaksanakan

26.

Bagaimana penanganan
perubahan pada SPA

27.
28.

Observasi
1
2

SISTEM UDARA
BERTEKANAN YANG
KONTAK DENGAN
PRODUK
Apakah sistem sudah
terkualifikasi
Apakah dilakukan
pemantauan mutu udara
bertekanan secara berkala
terutama pada titik
penggunaan

29.

Apakah dilakukan
pengkajian hasil
pemantauan

30.

Apakah semua deviasi

selalu dilaporkan sesuai
Protap

31.

Bagaimana pemeliharaan
Sistem Udara Bertekanan

PENGOLAHAN
LIMBAH
Bagaimana Protap
pengolahan limbah

32.

Komentar/Temuan

Bagian : Teknik dan Sistem Penunjang Kritis

Halaman 5 dari 5
Tingkat
kekritisan

No.

Daftar Periksa

Observasi
1

33.

Apakah dilakukan
pemantauan berkala
terhadap BOD dan COD
limbah cair

34.

Bagaimana pemeliharaan
sistem pengolahan limbah
cair

35.

Bagaimana sistem
pengelolahan limbah

36.

Bagaimana sistem
pengelolahan limbah B3

Komentar lain :.......................................................................

.......................................................................
.......................................................................
.......................................................................

Komentar/Temuan

Questionnaire for Manufacturer of Starting Material

PT OREVA FARMA
Questionnaire for Manufacturer of Starting Material
Name of material :
Piroxicam Active Agent
Name of manufacturer
Taixing Yiming Biological Products Co., Ltd. China

Person responsible for filling and completing this questionnaire

Name
Mr. Tang Jun
Function
Sales Manager

Signature

Tang Jun
Location and Date
Dajing Village, Gensi Township, Taixing, Jiangsu, China (Mainland) No.5 Tongjiang
Road China fax 86-523-87639636
Nov, 17th 2015

A. General Information

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

11.

12.
13.
14.

Questionnaire For Supplier of Raw Material

What is the name of active
agent to be audited?
What is the name and address
of supplier company?
Telephone, fax number, and
email of supplier company.
Name of person that regard to
quality
Does your company have
website that provides an
overview of your activities?
If so, please specify.
Number of employees at your
company.
Are there any companies
located in your area of
production?
If so, please specify the
company. What kind of
activities they do?
How to order and buy the
materials?
How about delivery of this
material?
Is your company a pure
production plant or are there
any activities, such as research
and development?
If so, please specify.
Is there any information about
your company that auditors
could use for preparation
before auditing?
How about if the material
doesnt arrive on time?
How about packaging of
delivery material?

B. Quality System
1.

2.

3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.

14.

15.

Does your company follow

GMP?
If so, please specify.
Please provide us information
about latest inspection by local
Authority (authority, date and
outcome).
Does your company get any
certificate
from
local
Authority?
Does your company maintain
Quality Management System?
Name of person authorised to
release material to be sold.
Does your company have your
own laboratory or use any
contract laboratories?
How do you do your own self
inspection? Is it by yourself or
any consultant?
If so, please specify the
consultant you work with.
Please provide us with an
example of certificate of
analysis.
Does your company have your
own self inspection schedule?
If so, please specify.
How do you handle any recall
product?
How do you handle of any
complaints?
How do you handle any out of
stock product to be ordered?
Do your employees be trained
regularly?
If so, please provide us with
the schedule and is it welldocumented?
How to control the process of
this industry?

C. Product-related Information
How about route of
manufacturing?
Please
1. describe how do you
produce the material to be
audited?
Does your company have
2. establish your own impurity
profile of material?
Do you use any organic
3. solvent
in
material
manufacturing?
If so, please mention it and
how do you ensure that
4. there
is
no
any
contamination because of its
use?
What kind of acceptance
5.
criteria do you use?
If its multi-function one,
how could you ensure that
6. there
is
no
any
contamination because of its
use?
What kind of equipment do
you use to produce the
7. material to be audited? Is it
a dedicated equipment or
multi-function one?
If its multi-function one,
how many times you clean
8.
it? Has the cleaning
procedur been validated?
Please describe us your
stability test of material to
9.
be audited.
When do you do the re-test?
Where do you store the
material to be audited?
Do you use your own
10.
storage or use any contract
storage?
If so, please specify.

11.

Please provide us with

Material Safety Data Sheet
of material to be audited.

D. GMP-related Information
Please decribe how you
1.
handle the raw material.
Have critical process of
manufacturing been defined
2.
and validated?
If so, please specify.
Please describe how you
3.
maintain and calibrate the
instruments you used.
How many times you
4.
calibrate the instruments?
Who
calibrate
the
instruments? Is it your own
5.
technical staff? Or do you
ask any external technical
staff?
If you ask any external
6.
technicall
staff,
please
specify it.
Is there any schedule of
instruments calibrating? Is
7.
the procedure and outcome
well-documented?
What kind of room do you
8.
use to produce the material
to be audited?
How woould you define the
air and environment quality
9.
where the material to be
audited are exposed?
Please describe how you
10.
pack the end product.
Please describe how you
11.
label the end product.
How do you ensure that
there is no contamination
12.
from room of production to
the material to be audited?
13.
What acceptance criteria do
you use to ensure there is no
contamination from this
area/s? (regarding to the 12th

question)

Questionnaire for Manufacturer of Starting Material

PT OREVA FARMA
Questionnaire for Manufacturer of Starting Material
Name of material :
PVP K-30 Excipient
Name of manufacturer
Pharcem Specialty Chemical Products Co., Ltd. New York

Person responsible for filling and completing this questionnaire

Name
Mr. Jonathan Auerbach
Function
Sales Manager

Signature

Jonathan
Location and Date
415 Huguenot Street, New Rochelle, New York, 10801
Phone: (914) 654-6800, Fax: (914) 654-6899
Nov, 16th 2015

A. General Information

1.

Questionnaire For Supplier of Raw Material

What is the name of excipient
material to be audited?

2.

What is the name of the company

that produces the excipient?

3.

Address, contact person, and

websites that can be contacted in
the order process

4.

How do excipient materials

delivery?

5.

Who is responsible for ordering or

purchasing of excipient materials?

6.

How long it took the delivery of

raw materials excipients ordered?

7.

How monitoring delivery excipient

materials are ordered?

8.

What if the excipient materials

purchased does not arrive on time?

9.

Does the company make the list

excipient materials are sold?

10.

Does the industry is only supplying

excipient materials or other
activities?

11.

How packaging of excipient

materials are purchased?

12.

What parameters are given on the

certificate of analysis of raw
materials excipients?

13.

How does the company in

maintaining the stability of raw
materials excipients upon delivery
to the consumer?

14.

How do consumers claim excipient

raw materials damaged upon
delivery?

B. Quality System
1.

2.

3.
4.
6.
7.
8.
9.
10.
11.
12.
13.

14.

15.

Does your company follow

GMP?
If so, please specify.
Please provide us information
about latest inspection by local
Authority (authority, date and
outcome).
Does your company get any
certificate
from
local
Authority?
Does your company maintain
Quality Management System?
Does your company have your
own laboratory or use any
contract laboratories?
How do you do your own self
inspection? Is it by yourself or
any consultant?
If so, please specify the
consultant you work with.
Please provide us with an
example of certificate of
analysis.
Does your company have your
own self inspection schedule?
If so, please specify.
How do you handle any recall
product?
How do you handle of any
complaints?
How do you handle any out of
stock product to be ordered?
Do your employees be trained
regularly?
If so, please provide us with
the schedule and is it welldocumented?
How to control the process of
this industry?

C. Product-related Information
How about route of manufacturing?
1. Please describe how do you produce
the material to be audited?
Does your company have establish
2.
your own impurity profile of material?
Do you use any organic solvent in
3.
material manufacturing?
If so, please mention it and how do
4. you ensure that there is no any
contamination because of its use?
If its multi-function one, how could
5. you ensure that there is no any
contamination because of its use?
What kind of equipment do you use to
produce the material to be audited? Is
6.
it a dedicated equipment or multifunction one?
If its multi-function one, how many
7. times you clean it? Has the cleaning
procedur been validated?
Please describe us your stability test of
8. material to be audited.
When do you do the re-test?
Where do you store the material to be
audited?
9. Do you use your own storage or use
any contract storage?
If so, please specify.
Please provide us with Material Safety
10.
Data Sheet of material to be audited.
Are you prepare sampling guidelines
11.
for the excipient(s)?
Can you clarify monograph
requirements or product specifications
12.
is sufficient to establish consistency in
the quality of the excipient?
Do you control over the following
13.
aspects of excipient quality?
What are the recommendations for
14. stability testing data of modified
release dosage forms?
15. How do you control your excipient(s)

consistency?
D. GMP-related Information
Please decribe how you
1.
handle the raw material.
Have critical process of
manufacturing been defined
2.
and validated?
If so, please specify.
Please describe how you
3.
maintain and calibrate the
instruments you used.
How many times you
4.
calibrate the instruments?
Who
calibrate
the
instruments? Is it your own
5.
technical staff? Or do you
ask any external technical
staff?
If you ask any external
6.
technicall
staff,
please
specify it.
Is there any schedule of
instruments calibrating? Is
7.
the procedure and outcome
well-documented?
What kind of room do you
8.
use to produce the material
to be audited?
How woould you define the
air and environment quality
9.
where the material to be
audited are exposed?
Please describe how you
10.
pack the end product.
Please describe how you
11.
label the end product.
How do you ensure that
there is no contamination
from room of production to
the material to be audited?
12.
And what
acceptance
criteria do you use to ensure
there is no contamination
from this area/s?

Questionnaire for Manufacturer of Starting Material

PT OREVA FARMA
Questionnaire for Manufacturer of Starting Material
Name of material :
Propylene Gylycol Excipient
Name of manufacturer
ANNOVA Pharmaceutical Co., Ltd. London

Person responsible for filling and completing this questionnaire

Name
Mr. Marco Christian
Function
Sales Manager

Signature

MarcChristi
Location and Date
ANNOVA Pharmaceutical, St Pittersburg Street Number 20, London Phone: 028121231,
Fax: 03214143
Nov, 15th 2015

AUDIT QUESTIONNAIRE FOR

SUPPLIER MANUFACTURE
MATERIAL
1.
2.
3.
4.
5.
6.

Supplier Name
Address
Telp./fax
Supplied Product
Audit time
Discussion participants
Name
Position Supplier
Supplier Company
7. Name of responsibilier
Production
Purchase
Quality Assurance

: PT Annova Pharmaceutical
: St Pittersburg Street Number 20, London
: 028121231/03214143
: Propylene Gylycol
: November, 15, 2015
: Rizki Arasyia, B.Pharm, Apt.
: Layo Beauty Street
: PT. Otsunika Inc.
: Propylene glycol
: Cash
: Randi Hermawan, S.Farm., Apt

8. How long the company has entered

into a cooperative relationship with
propylene glycol suppliers?
9. How about the company stresses to
suppliers of propylene glycol that
the quality is very important factor?
10. Is the production process the
company's ability to meet the
requirements of the production of
propylene glycol?
11. Whether as a supplier company has
clearing quality guidelines to
produce the quality propylene
glycol?
12. Whether the Company has a
documents of working procedure
remaining clear?
13. Whether the company has to follow
the requirements of ISO 9001 and
GMP as a guidelines to establishing
a quality system supplier?
14. Is a supplier company receives
complaints
comprehensive
information contracting company?
15. Whether the quality of the quality
of propylene glycol related to the

complaints handled contracting

company as a top priority?
16. Whether the company is a supplier
giving a guarantee of the product
sold the company contracting
authority?
17. Are our company provides the
customers a special price as
propylene glycol material?
18. How long your company has been
focused as a change inmaterial
supplier of propylene glycol?
19. Whether during the manufacturing
process of propylene glycol were
given a clear identity?
20. Is
propylene
glycol-making
materials in accordance with the
schedule?
21. How about your companies
contribution to prevent propylene
glycol began to organize the
storage
of
materials,
room
temperature, pressure and airflow,
explain?
22. Is the raw material of propylene
glycol examined by the quality
control section and other parts that
are authorized to ensure the quality
of quality?
23. Does your company provide
documentation as a proof that the
materials we purchase propylene
glycol has met the test of the
quality requirements?
24. Is the environmental conditions of
production
are
eligible
for
propylene glycol kinds of products
are made?
25. Whether supervision in the
production process of propylene
glycol and controlled testing
procedures?
26. Is
available
specifications,
sampling pattern, and defect
classification of the materials that

we used ?
27. If a material being processed is
rejected, whether explained the
reasons for the rejection?
28. If the stated corrective action to
prevent a recurrence of the same
problem if the material being
processed is rejected?
29. How about the color standards for
the materials of propylene glycol?
30. Does the company have a clear
quality guidelines for propylene
glycol quailities of produce?
31. Would you please provide us with a
brief description of the route of
manufacture?
32. How to identified propylene
glycol ?
33. Has the impurity profile of the
propylene glycol been established?
34. Would you please explain us about
the toxicological information of
this material?
35. How to transport propylene glycol?
36. How to stability of the material
during shipment?
37. Please the describe how to handling
and storage of propylene glycol ?
Please justify your re-test expiry
dates?
38. Is the propylene glycol stored at the
facilities to be audited?
39. Have the cleaning procedures
equipment been validated and what
acceptance criteria is used?
40. Are microbiological aspects of
specifications relevant?
41. Do you have a recall procedure in
place?
42. Do you have a procedure for
handling of complaints?
43. Would you please provide a
material safety data sheet?
44. Please describe how you control
the status of raw materials and the

location of production
45. Could you define the air and the
environments quality where the
materials are exposed?