ORIGINAL Confidential (Bilingual)

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STANDARD OPERATING
PT. CAPRIFARMINDO PROCEDURE Revision No.: 01
LABORATORIES
Subject : Penentuan Acceptance Next Review Date:
Range Yield / Determine of Document No.:
Acceptance Range Yield PRO-NS/SOP/CP/037
Location/ Department : : Produksi
Effective Date Prepared by, Reviewed by, Reviewed by, Reviewed by,

Production Solid Production Solid Production Liquid & Semisolid

Supervisor Manager I Manager II Production Manager I
Reviewed by, Reviewed by, Approved by,

Liquid Production Manager II Plant Manager QA Manager

DAFTAR ISI /TABLE OF CONTENTS

1. TUJUAN/PURPOSE 2
2. RUANG LINGKUP/SCOPE 2
3. DEFINISI/DEFINITION 2
4. PUSTAKA/REFERENCES 2
5. TANGGUNG JAWAB/RESPONSIBILITIES 2
6. PROSEDUR/PROCEDURES 2
7. FREKUENSI PENINJAUAN ULANG/REVIEW FREQUENCY 7
8. LAMPIRAN/APPENDICES 7
9. SEJARAH REVISI/REVISION HISTORY 8

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1. TUJUAN/PURPOSE

Prosedur ini digunakan sebagai panduan dalam menentukan acceptance range yield pada
tahapan proses mixing, compressing, filling, primary packaging dan secondary packaging
yang tercantum dalam dokumen batch record.
This procedure is used as a guide in determining the yield acceptance range at the stages of
the mixing, compressing, filling, primary and secondary packaging processes listed in the
batch record document.

2. RUANG LINGKUP/SCOPE
Prosedur ini berlaku untuk penentuan acceptance range yield dalam dokumen batch record
pada tahapan proses produksi seluruh produk solid, semisolid dan liquid yang diproduksi di
PT. Caprifarmindo Laboratories.
This procedure applies to determining the acceptance range yield in the batch record
document at the stages of the production process for all solid, semisolid and liquid products
produced at PT. Caprifarmindo Laboratories.

3. DEFINISI/DEFINITION
3.1. Acceptance range yield adalah rentang penerimaan yield yang dihasilkan setelah
melakukan suatu tahapan proses produksi sediaan obat. Acceptance range yield
tercantum dalam catatan pengolahan, catatan penyalutan, dan catatan pengemasan batch,
tepatnya pada tahapan proses rekonsiliasi.
Acceptance range yield is the yield acceptance range that is produced after carrying out
a stage of the production process for medicinal preparations. Acceptance range yields
are listed in processing records, coating records, and batch packaging records, precisely
at the reconciliation process stage.
3.2. Rekonsiliasi adalah perbandingan antara hasil aktual yang diperoleh dari suatu tahapan
proses produksi terhadap hasil aktual tahapan proses sebelumnya atau terhadap jumlah
teoritis.
Reconciliation is a comparison between the actual results obtained from a stage of the
production process against the actual results of the previous process stages or against
the theoretical amount.
3.3. Batas atas adalah batas nilai tertinggi dari standar yang ditetapkan.
The upper limit is the upper limit of the specified standard.
3.4. Batas bawah adalah batas nilai terendah dari standar yang ditetapkan
The lower limit is the lower limit of the set standard
3.5. Simbol sigma (σ) adalah suatu nilai yang menyatakan simpangan terhadap nilai tengah
(x̄ ).
The sigma symbol (σ) is a value that represents the deviation from the mean value (x̄ ).

4. PUSTAKA/REFERENCES

4.1. WHO Technical Report Series No.986, 2014, Annex 2.

WHO Technical Report Series No.986, 2014, Annex 2.
4.2. Six Sigma For Quality and Productivity Promotion, 2003, Asian Productivity
Organization, ISBN: 92-833-1722-X.
Six Sigma For Quality and Productivity Promotion, 2003, Asian Productivity
Organization, ISBN: 92-833-1722-X.
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5. TANGGUNG JAWAB/RESPONSIBILITIES

5.1. Supervisor Produksi/Production Supervisor

Bertanggung jawab untuk menentukan acceptance range yield produk sesuai dengan
prosedur.
Responsible for determining the acceptance range of product yields in accordance with
the procedure.
5.2. Manajer Produksi/ Production manager
Memastikan bahwa prosedur ini dilaksanakan dengan baik dan benar.
Ensure that this procedure is carried out properly and correctly.
6. PROSEDUR/PROCEDURES
6.1. Ketentuan penulisan nilai acceptance range yield pada batch record:
Provisions for writing the acceptance range yield value on the batch record:
6.1.1 Acceptance range yield terdiri dari batas atas dan batas bawah untuk masing-
masing yield produk tersebut berupa persentase (%).
Acceptance range yield consists of the upper and lower limits for each product
yield in the form of a percentage (%).
6.1.2 Penulisan acceptance range yield berlaku hanya 1 angka dibelakang koma.
Writing acceptance range yield applies only 1 digit behind the comma.
6.1.3 Hasil pembulatan acceptance range yield dilakukan terhadap 1 angka yang
terdapat dibelakang koma, jika hasil ≥5 maka pembulatan ke atas dan jika hasil
<5 maka pembulatan ke bawah.
The results of the acceptance range yield are rounded off to 1 number behind
the comma, if the result is ≥5 then it is rounded up and if the result is <5 then
it is rounded down.
Contoh/Example :
a. Apabila didapatkan hasil acceptance range yield 96,44% maka setara
dengan 96,4%
If the acceptance range yield is 96.44%, it is equivalent to 96,4%
b. Apabila didapatkan hasil acceptance range yield 95,96% maka setara
dengan 96,0%
If the acceptance range yield is 95.96%, it is equivalent to 96,0%
c. Apabila didapatkan hasil acceptance range yield 97,55% maka setara
dengan 97,6%
If the acceptance range yield is 97.55%, it is equivalent to 97,6%
d. Apabila didapatkan hasil acceptance range yield 100,04% maka setara
dengan 100,0%
If the acceptance range yield is 100.04%, it is equivalent to 100.0%

6.2. Produk solid terdiri dari sediaan tablet/kaplet uncoated, film coated caplet (FCC), tablet
effervescent dan kapsul.
Solid products consist of uncoated tablets/caplets, film coated caplets (FCC),
effervescent tablets and capsules.
6.2.1 Tablet/Kaplet Uncoated/Uncoated Tablets/Caplets
Pengemasan Pengemasan
Pencampuran/ Cetak
Primer/Primary Sekunder/
Mixing /Compressing
packaging Secondary packaging

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Acceptance range yield rekonsiliasi tahapan Acceptance range yield secondary

proses mixing, compressing, primary packaging packaging terhadap batch size teoritis:
dan secondary packaging: Acceptance range of secondary packaging
Acceptance range yield reconciliation of the yield to theoretical batch size:
stages of the mixing, compressing, primary and  Batas atas = 3 x σ atau maksimum
secondary packaging processes: 102,0% (dahulukan yang tercapai
 Batas atas = maksimum 102,0% terlebih dahulu)
Upper limit = maximum 102,0% Upper limit = 3 x σ or maximum
 Batas bawah ≥ 96,0% 102,0% (first achieved first)
Lower limit ≥ 96,0%  Batas bawah = 3 x σ atau ≥ 96,0%
(dahulukan yang tercapai terlebih
dahulu)
Lower limit = 3 x σ or ≥ 96,0% (first
achieved first)

6.2.2 Film Coated Caplet (FCC)

Pengemasan Pengemasan
Pencampuran Cetak Penyalutan/ Sekunder/
/Mixing Primer/Primary
/Compressing Coating Secondary
packaging
packaging

Acceptance range yield rekonsiliasi Acceptance range yield secondary packaging

tahapan proses mixing, compressing,
coating, primary packaging dan secondary
packaging:
Range of acceptance of the reconciliation
results of the stages of the mixing,
compressing, coating, primary and
secondary packaging processes
 Batas atas = maksimum 102,0%
Upper limit = maximum 102,0%
 Batas bawah ≥ 96,0%
Lower limit 96,0%
terhadap batch size teoritis:
Acceptance range of secondary packaging yield
to theoretical batch size:
 Batas atas = 3 x σ atau maksimum 102,0%
(dahulukan yang tercapai terlebih dahulu)
Upper limit = 3 x σ or maximum 102,0%
(first achieved first)
 Batas bawah = 3 x σ atau ≥ 96,0%
(dahulukan yang tercapai terlebih dahulu)
Lower limit = 3 x σ or ≥ 96,0% (first
achieved first)

6.2.3 Tablet Effervescent/ Effervescent Tablets

Pengemasan Pengemasan
Pencampuran/ Cetak
Primer/Primary Sekunder/
Mixing /Compressing
packaging Secondary packaging
Acceptance range yield rekonsiliasi Acceptance range yield secondary packaging
tahapan proses mixing, compressing, terhadap batch size teoritis:
coating, primary packaging dan secondary Acceptance range of secondary packaging yield
packaging: to theoretical batch size:
Range of acceptance of the reconciliation  Batas atas = 3 x σ atau maksimum 102,0%
results of the stages of the mixing, (dahulukan yang tercapai terlebih dahulu)
compressing, coating, primary and Upper limit = 3 x σ or maximum 102,0%
secondary packaging processes (first achieved first)
 Batas atas = maksimum 102,0%  Batas bawah = 3 x σ atau ≥ 96,0%
Upper limit = maximum 102,0% (dahulukan
\\Cimareme\Release\Capri\PRO\NS\SOP\PRO-NS.SOP.CP.037 – Penentuan Acceptance yang
Range Yield tercapai terlebih dahulu)
- R01.doc
 Batas bawah ≥ 96,0% Lower limit = 3 x σ or ≥ 96,0% (first
Lower limit ≥ 96,0% achieved first)
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6.2.4 Kapsul/ Capsule

Pengemasan Pengemasan
Pencampuran/ Pengisian Primer/Primary Sekunder/
Mixing /Filling packaging Secondary packaging

Acceptance range yield rekonsiliasi Acceptance range yield secondary

tahapan proses mixing, filling capsule, packaging terhadap batch size teoritis:
primary packaging dan secondary Acceptance range of secondary packaging
packaging: yield to theoretical batch size:
Acceptance range yield reconciliation of  Batas atas = 3 x σ atau maksimum
the stages of the mixing process, filling 103,0% (dahulukan yang tercapai
capsule, primary packaging and secondary terlebih dahulu)
packaging: Upper limit = 3 x σ or maximum
 Batas atas = maksimum 105,0% 103,0% (first achieved first)
Upper limit = maximum 105,0%  Batas bawah = 3 x σ atau ≥ 96,0%
 Batas bawah ≥ 96,0% (dahulukan yang tercapai terlebih
Lower limit ≥ 96,0% dahulu)
Lower limit = 3 x σ or ≥ 96,0% (first
achieved first)

6.3. Produk semisolid terdiri dari sediaan cream, emulgel, gel, ointment, oral pasta
suppositoria dan ovula.

6.3.1 Krim / Cream

Acceptance range yield secondary packaging
Pengemasan
Pencampuran Pengisianterhadap batch size teoritis:
Sekunder/
/Mixing /Filling Acceptance range of secondary packaging
Acceptance range yield rekonsiliasi Secondary
yield to theoretical batch packaging
size:
tahapan proses mixing, filling dan  Batas atas = 3 x σ atau maksimum
secondary packaging: 102,0% (dahulukan yang tercapai terlebih
Acceptance range yield reconciliation of dahulu)
the stages of the mixing, filling and Upper limit = 3 x σ or maximum 102,0%
secondary packaging process: (first achieved first)
 Batas atas = maksimum 102,0%  Batas bawah = 3 x σ atau ≥ 96,0%
Upper limit = maximum 102,0%
\\Cimareme\Release\Capri\PRO\NS\SOP\PRO-NS.SOP.CP.037 (dahulukan
– Penentuan Acceptance yang
Range Yield tercapai terlebih dahulu)
- R01.doc

 Batas bawah ≥ 96,0% Lower limit = 3 x σ or ≥ 96,0% (first

Lower limit ≥ 96,0% achieved first)
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6.3.2 Emulgel dan gel

Pencampuran Pengemasan
Pengisian
/Mixing Sekunder/
/Filling
Secondary packaging

Acceptance range yield rekonsiliasi Acceptance range yield secondary packaging

tahapan proses mixing, filling dan terhadap batch size teoritis:
secondary packaging: Acceptance range of secondary packaging
Acceptance range yield reconciliation of yield to theoretical batch size:
the stages of the mixing, filling and  Batas atas = 3 x σ atau maksimum
secondary packaging process: 102,0% (dahulukan yang tercapai terlebih
 Batas atas = maksimum 102,0% dahulu)
Upper limit = maximum 102.0% Upper limit = 3 x σ or maximum 102,0%
 Batas bawah ≥ 96,0% (first achieved first)
Lower limit ≥ 96,0%  Batas bawah = 3 x σ atau ≥ 95,0%
(dahulukan yang tercapai terlebih dahulu)
Lower limit = 3 x σ or ≥ 95,0% (first
achieved first)

6.3.3 Ointment

Pencampuran Pengemasan
Pengisian
/Mixing Sekunder/
/Filling
Secondary packaging
Acceptance range yield secondary packaging
terhadap batch size teoritis:
Acceptance range of secondary packaging
Acceptance range yield rekonsiliasi yield to theoretical batch size:
tahapan proses mixing, filling dan  Batas atas = 3 x σ atau maksimum
secondary packaging: 102,0% (dahulukan yang tercapai terlebih
Acceptance range yield reconciliation of dahulu)
the stages of the mixing, filling and Upper limit = 3 x σ or maximum 102,0%
secondary packaging process: (first achieved first)
 Batas atas = maksimum 102,0%  Batas bawah = 3 x σ atau ≥ 95,0%
Upper limit = maximum 102,0%
\\Cimareme\Release\Capri\PRO\NS\SOP\PRO-NS.SOP.CP.037 (dahulukan
– Penentuan Acceptance yang
Range Yield tercapai terlebih dahulu)
- R01.doc

 Batas bawah ≥ 96,0% Lower limit = 3 x σ or ≥ 95,0% (first

Lower limit ≥ 96,0% achieved first)
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6.3.4 Oral pasta

Pencampuran Pengemasan
Pengisian
/Mixing Sekunder/
/Filling
Secondary packaging

Acceptance range yield rekonsiliasi Acceptance range yield secondary packaging

tahapan proses mixing, filling dan terhadap batch size teoritis:
secondary packaging: Acceptance range of secondary packaging
Acceptance range yield reconciliation of yield to theoretical batch size:
the stages of the mixing, filling and  Batas atas = 3 x σ atau maksimum
secondary packaging process: 102,0% (dahulukan yang tercapai terlebih
 Batas atas = maksimum 102,0% dahulu)
Upper limit = maximum 102.0% Upper limit = 3 x σ or maximum 102,0%
 Batas bawah ≥ 96,0% (first achieved first)
Lower limit ≥ 96,0%  Batas bawah = 3 x σ atau ≥ 92,0%
(dahulukan yang tercapai terlebih dahulu)
Lower limit = 3 x σ or ≥ 92,0% (first
achieved first)

6.3.5 Suppositoria dan ovula /

Pencampuran/ Pengisian Pendinginan/ Penyegelan/

Mixing /Filling Cooling Sealing

Acceptance range yield secondary

Pengemasan packaging
Sekunder/
terhadap batch size teoritis: Secondary packaging
Acceptance range of secondary packaging
Acceptance range yield rekonsiliasi yield to theoretical batch size:
tahapan proses mixing, filling dan  Batas atas = 3 x σ atau maksimum
secondary packaging: 102,0% (dahulukan yang tercapai terlebih
Acceptance range yield reconciliation of dahulu)
the stages of the mixing, filling and Upper limit = 3 x σ or maximum 102,0%
secondary packaging process: (first achieved first)
 Batas atas = maksimum 102,0%  Batas bawah = 3 x σ atau ≥ 92,0%
Upper limit = maximum 102,0%
\\Cimareme\Release\Capri\PRO\NS\SOP\PRO-NS.SOP.CP.037 (dahulukan
– Penentuan Acceptance Range Yieldyang tercapai terlebih dahulu)
- R01.doc

 Batas bawah ≥ 96,0% Lower limit = 3 x σ or ≥ 92,0% (first

Lower limit ≥ 96,0% achieved first)
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6.4. Produk liquid terdiri dari syrup, suspensi, emulsi, oral solution preparation dan dry
syrup
Liquid products consist of syrups, suspensions, emulsions, oral solution preparations and
dry syrups
6.4.1 Sirup/Syrup

Pencampuran Pengemasan
Pengisian
/Mixing Sekunder/
/Filling
Secondary packaging

Acceptance range yield rekonsiliasi Acceptance range yield secondary packaging

tahapan proses mixing, filling dan terhadap batch size teoritis:
secondary packaging: Acceptance range of secondary packaging
Acceptance range yield reconciliation of yield to theoretical batch size:
the stages of the mixing, filling and  Batas atas = 3 x σ atau maksimum
secondary packaging process: 102,0% (dahulukan yang tercapai terlebih
 Batas atas = maksimum 102,0% dahulu)
Upper limit = maximum 102,0% Upper limit = 3 x σ or maximum 102,0%
 Batas bawah ≥ 96,0% (first achieved first)
Lower limit ≥ 96,0%  Batas bawah = 3 x σ atau ≥ 96,0%
(dahulukan yang tercapai terlebih dahulu)
Lower limit = 3 x σ or ≥ 96,0% (first
achieved first)

6.4.2 Suspensi / Suspensi

Pencampuran Pengemasan
Pengisian
Acceptance range yield secondary
/Mixing Sekunder/packaging
/Filling
terhadap batch size teoritis:
Secondary packaging
Acceptance range of secondary packaging
Acceptance range yield rekonsiliasi yield to theoretical batch size:
tahapan proses mixing, filling dan  Batas atas = 3 x σ atau maksimum
secondary packaging: 102,0% (dahulukan yang tercapai terlebih
Acceptance range yield reconciliation of dahulu)
the stages of the mixing, filling and Upper limit = 3 x σ or maximum 102,0%
secondary packaging process: (first achieved first)
 Batas atas = maksimum 102,0%  Batas bawah = 3 x σ atau ≥ 96,0%
Upper limit = maximum 102,0% – Penentuan Acceptance
\\Cimareme\Release\Capri\PRO\NS\SOP\PRO-NS.SOP.CP.037 (dahulukan
Range Yieldyang tercapai terlebih dahulu)
- R01.doc

 Batas bawah ≥ 96,0% Lower limit = 3 x σ or ≥ 96,0% (first

Lower limit ≥ 96,0% achieved first)
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6.4.3 Emulsi / Emulsi

Pencampuran Pengemasan
Pengisian
/Mixing Sekunder/
/Filling
Secondary packaging

Acceptance range yield rekonsiliasi Acceptance range yield secondary packaging

tahapan proses mixing, filling dan terhadap batch size teoritis:
secondary packaging: Acceptance range of secondary packaging
Acceptance range yield reconciliation of yield to theoretical batch size:
the stages of the mixing, filling and  Batas atas = 3 x σ atau maksimum
secondary packaging process: 102,0% (dahulukan yang tercapai terlebih
 Batas atas = maksimum 102,0% dahulu)
Upper limit = maximum 102,0% Upper limit = 3 x σ or maximum 102,0%
 Batas bawah ≥ 96,0% (first achieved first)
Lower limit ≥ 96,0%  Batas bawah = 3 x σ atau ≥ 96,0%
(dahulukan yang tercapai terlebih dahulu)
Lower limit = 3 x σ or ≥ 96,0% (first
achieved first)

6.4.4 Oral Solution Preparation (OSP)

Pencampuran Pengemasan
Pengisian
/Mixing Sekunder/
/Filling
Secondary packaging

Acceptance range yield secondary packaging

terhadap batch size teoritis:
Acceptance range of secondary packaging
Acceptance range yield rekonsiliasi yield to theoretical batch size:
tahapan proses mixing, filling dan  Batas atas = 3 x σ atau maksimum
secondary packaging: 102,0% (dahulukan yang tercapai terlebih
Acceptance range yield reconciliation of dahulu)
the stages of the mixing, filling and Upper limit = 3 x σ or maximum 102,0%
secondary packaging process: (first achieved first)
 Batas atas = maksimum 102,0%  Batas bawah = 3 x σ atau ≥ 96,0%
Upper limit = maximum 102.0%
\\Cimareme\Release\Capri\PRO\NS\SOP\PRO-NS.SOP.CP.037 (dahulukan
– Penentuan Acceptance Rangeyang tercapai terlebih dahulu)
Yield - R01.doc

 Batas bawah ≥ 96,0% Lower limit = 3 x σ or ≥ 96,0% (first

Lower limit ≥ 96,0% achieved first)
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6.4.5 Sirup Kering / Dry syrup

Pencampuran Pengemasan
Pengisian
/Mixing Sekunder/
/Filling
Secondary packaging

Acceptance range yield rekonsiliasi Acceptance range yield secondary packaging

tahapan proses mixing, filling dan terhadap batch size teoritis:
secondary packaging: Acceptance range of secondary packaging
Acceptance range yield reconciliation of yield to theoretical batch size:
the stages of the mixing, filling and  Batas atas = 3 x σ atau maksimum
secondary packaging process: 102,0% (dahulukan yang tercapai terlebih
 Batas atas = maksimum 102,0% dahulu)
Upper limit = maximum 102.0% Upper limit = 3 x σ or maximum 102,0%
 Batas bawah ≥ 96,0% (first achieved first)
Lower limit ≥ 96,0%  Batas bawah = 3 x σ atau ≥ 96,0%
(dahulukan yang tercapai terlebih dahulu)
Lower limit = 3 x σ or ≥ 96,0% (first
achieved first)
Note : 3 x σ didapatkan dari hasil trend data pada masing – masing produk dengan batch
size yang sama, dimana range antara batas bawah dan batas atas dari garis tengah (x̄ )
adalah 3 x σ.
Note: 3 x σ is obtained from the trend data results for each product with the same batch
size, where the range between the lower limit and the upper limit of the center line (x̄ ) is
3 x σ.
6.5. Penentuan acceptance range yield pada batch record produk baru untuk seluruh sediaan
yaitu sebagai berikut:
Determination of acceptance range yield on new product batch records for all
preparations are as follows:
6.5.1 Pengambilan data berdasarkan produk yang sama dengan batch size yang
sama
Data collection based on the same product with the same batch size
6.5.2 Acceptance range yield rekonsiliasi tahapan proses:
Acceptance range yield reconciliation process stages:
Batas atas = 102,0%
Upper limit = 102,0%
Batas bawah ≥ 96,0%
Lower limit 96,0%
6.5.3 Acceptance range yield rekonsiliasi secondary packaging terhadap batch
\\Cimareme\Release\Capri\PRO\NS\SOP\PRO-NS.SOP.CP.037 – Penentuan Acceptance Range Yield - R01.doc
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size teoritis yaitu:

Acceptance range yield reconciliation of secondary packaging to the
theoretical batch size, namely:
Batas atas = 102,0%
Upper limit = 102,0%
Batas bawah ≥ 96,0%
Lower limit 96,0%
6.5.4 Acceptance range yield untuk produk baru akan berubah setelah terdapat
trend data 20-30 batch atau sesuai dengan justifikasi/studi mengenai
penentuan Acceptance range yield.
Acceptance range yield for new products will change after there is a trend of
20-30 batches of data or according to justification/study regarding the
determination of Acceptance range yield.

7. FREKUENSI PENINJAUAN ULANG/REVIEW FREQUENCY

Prosedur ini perlu ditinjau ulang 3 tahun setelah tanggal efektif atau jika ada perubahan.
This procedure needs to be reviewed 3 years after the effective date or if there is a change.

8. LAMPIRAN/APPENDICES
8.1 Standard Yield Produksi Solid (PRO-NS/LIS/MB/004).
Standard Yield Solid Production (PRO-NS/LIS/MB/004).
8.2 Standard Yield Produksi Semisolid & Liquid I (PRO-NS/LIS/MB/002).
Standard Yield for Semisolid & Liquid Production I (PRO-NS/LIS/MB/002).
8.3 Standard Yield Produksi Liquid II (PRO-NS/LIS/CP/006).
Standard Yield for Liquid Production II (PRO-NS/LIS/CP/006).

9. SEJARAH REVISI/REVISION HISTORY

No. Revisi/ Tanggal/ Penyusun/

Deskripsi/ Description
No Revision Date Originator
01 September 2018/
00 Dokumen Baru/ New Document Iqbal Aya S.
01 September 2018
06 Januari 2021 / Merubah SOP menjadi Bilingual
01 Changed SOP to Bilingual N. Intan Fratiwi
06 January 2021

\\Cimareme\Release\Capri\PRO\NS\SOP\PRO-NS.SOP.CP.037 – Penentuan Acceptance Range Yield - R01.doc