| 22-0430-D |
E |
Audit Unilab tahun 2022
Staging room for weighed non-precursor materials was congested. There was no passageway for personnel |
m |
PA |
Expanding Storage Area (CAPEX) |
DEDY AKHFA |
31 Dec 2024 |
Open |
Detail |
| 22-0432-D |
E |
Audit Unilab tahun 2022
Equipment tags for the Fitzmill and Mixer in the Granulation 4 Room were not available. |
m |
CA |
Put ID number in all production machine |
Mujino |
31 Mar 2023 |
Open |
Detail |
| 22-0433-D |
E |
Audit Unilab tahun 2022
Lapses in the qualification of computer systems were observed, as follows:
a. Performance Qualification Report for Chromeleon Version 7.2.10 MUa was not yet available at the time of audit.
b. The following were noted in the Computer System Validation Report for SAP:
i. Challenge test for the transaction involving rejected items (materials and products) was not conducted. In the report, it was done only for the items under quarantine;
ii. Material status, with corresponding color code (i.e., red for rejected, yellow for quarantine, and green for approved), is displayed through the handheld device. However, this functionality was not included as a test parameter during validation;
c. Binder software used to monitor the storage condition of stability chambers was not validated.
|
M |
PA |
Perform checking to all equipment and software in QC whether equipment has PQ report or not or validation report. |
Suci Rahmawati; Erlinda; Rachma Yuliana |
14 Mar 2023 |
Open |
Detail |
| 22-0433-D |
E |
Audit Unilab tahun 2022
Lapses in the qualification of computer systems were observed, as follows:
a. Performance Qualification Report for Chromeleon Version 7.2.10 MUa was not yet available at the time of audit.
b. The following were noted in the Computer System Validation Report for SAP:
i. Challenge test for the transaction involving rejected items (materials and products) was not conducted. In the report, it was done only for the items under quarantine;
ii. Material status, with corresponding color code (i.e., red for rejected, yellow for quarantine, and green for approved), is displayed through the handheld device. However, this functionality was not included as a test parameter during validation;
c. Binder software used to monitor the storage condition of stability chambers was not validated.
|
M |
PA |
Perform PQ to equipment and validation software based on checking result. |
Suci Rahmawati; Erlinda; Rachma Yuliana |
15 Jun 2023 |
Open |
Detail |
| 22-0435-D |
E |
Audit Unilab tahun 2022
Deficiencies in the supplier qualification program were noted, as follows:
Qualification records of some suppliers and forwarders were not readily available since the audit process is shared with PT. Darya-Varia Laboratoria; |
m |
PA |
Complete the qualification documents for API supplier before 2018 |
Kiki Zakiah |
31 Dec 2023 |
Waiting RFE Approval by Dept Head |
Detail |
| 22-0437-D |
E |
Audit Unilab tahun 2022
During virtual observation of the strip packaging of Enervon Active, batch number 22233103, the actual sealing temperature (back) of HMI/290 was at 114ºC, which was below the BPR-prescribed temperature of 120-125ºC |
M |
CA |
Perform packaging validation based on current packaging process which running on machine HMI/290 for Enervon group |
QA VALIDATION |
28 Feb 2023 |
Open |
Detail |
| 23-0332-D |
E |
Cross Audit DVL 2023
The scoop used for dispense materials was not dedicated, it is necessary to carry out a cleaning validation matrix and ensure cleaning validation |
m |
CA |
Conduct cleaning validation of weighing tools (scoop) |
QA VALIDATION |
31 Jul 2023 |
Open |
Detail |
| 23-0334-D |
E |
Cross Audit DVL 2023
Acceptance criteria of cleaning validation should be documented on protocol related to quantity batch needed |
m |
CA |
Revise SOP Cleaning Validation and cleaning validation protocol template to add the provision of cleaning validation should be carried out three times cleaning
|
QA VALIDATION |
10 Jun 2023 |
Open |
Detail |
| 23-0335-D |
E |
Cross Audit DVL 2023
In the cabinet for sample storage, temperature monitoring include in the instrument room monitoring which not include MIN and MAX themperature per day. |
M |
CA |
Revise SOP room monitoring (QA07-SOP-223/12) by adding instrument room as storage room
|
QA VALIDATION |
10 Jun 2023 |
Open |
Detail |
| 23-0336-D |
E |
Cross Audit DVL 2023
There are some defficiencies in the spreadsheet validation report :
Calculation verification using calculator, but calculator not yet calibrated
|
m |
CA |
Create and training SOP for calibration calculator. |
QA VALIDATION |
24 Jun 2023 |
Open |
Detail |
| 23-0336-A |
E |
Cross Audit DVL 2023
There are some defficiencies in the spreadsheet validation report :
Calculation verification using calculator, but calculator not yet calibrated
|
m |
CA |
Perform calibration calculator |
QA VALIDATION |
30 Jun 2023 |
Open |
Detail |
| 23-0336-D |
E |
Cross Audit DVL 2023
There are some defficiencies in the spreadsheet validation report :
Calculation verification using calculator, but calculator not yet calibrated
|
m |
PA |
Addendum excel spreadsheet validation for others spreadsheet in QA area |
QA VALIDATION |
30 Jun 2023 |
Open |
Detail |
| 23-0337-D |
E |
Cross Audit DVL 2023
Cleaning sampling tools was done in booth sampling by using container filled with purified water, this could be potential cross contamination by cleaning process.
|
m |
CA |
Revise SOP Inspection & Sampling Raw Material to add procedure to cleaning sampling tools in dispensing area and procedure to transfer clean tools from dispensing area to sampling room area |
Leni Herlina; Sentia Agestina |
30 Jun 2023 |
Open |
Detail |
| 23-0337-D |
E |
Cross Audit DVL 2023
Cleaning sampling tools was done in booth sampling by using container filled with purified water, this could be potential cross contamination by cleaning process.
|
m |
CA |
Socialize SOP after revision |
Leni Herlina; Sentia Agestina |
30 Jun 2023 |
Open |
Detail |
| 22-0437-D |
E |
Audit Unilab tahun 2022
During virtual observation of the strip packaging of Enervon Active, batch number 22233103, the actual sealing temperature (back) of HMI/290 was at 114ºC, which was below the BPR-prescribed temperature of 120-125ºC |
M |
CA |
Revise packaging batch record product Enervon Active |
HENNY DWI MARYANI; ANTENG JATMIKO; EKO PRIYONO; SUSI MIRASARI; M Syauqi Abdullah
|
31 Mar 2023 |
Open |
Detail |
| 23-0333-D |
E |
Cross Audit DVL 2023
Clean hold time of production machine is 3 days. however, there is no study clean holding time on each machine. Clean hold time study only perform in one selected machine and only 1 batch. As per SOP Cleaning validation, cleaning validation should be carried out 3 batches. |
m |
CA |
Revise SOP Cleaning Validation and cleaning validation protocol template to add the provision of cleaning validation should be carried out three times cleaning |
QA VALIDATION |
10 Jun 2023 |
Open |
Detail |
| 23-0333-D |
E |
Cross Audit DVL 2023
Clean hold time of production machine is 3 days. however, there is no study clean holding time on each machine. Clean hold time study only perform in one selected machine and only 1 batch. As per SOP Cleaning validation, cleaning validation should be carried out 3 batches. |
m |
CA |
Training the revised SOP to related personnel |
QA VALIDATION |
10 Jun 2023 |
Open |
Detail |
| 22-0437-D |
E |
Audit Unilab tahun 2022
During virtual observation of the strip packaging of Enervon Active, batch number 22233103, the actual sealing temperature (back) of HMI/290 was at 114ºC, which was below the BPR-prescribed temperature of 120-125ºC |
M |
CA |
Training packaging batch record product Enervon Active after revised |
HENNY DWI MARYANI; ANTENG JATMIKO; EKO PRIYONO; SUSI MIRASARI; M Syauqi Abdullah
|
10 Apr 2023 |
Open |
Detail |
| 22-0441-D |
E |
Audit BPOM 2021
Belum memiliki buku kompendial terbaru misal Farmakope Indonesia VI dan buku standar terkini lainnya misal USP, BP, dll untuk memastikan pemutakhiran spesifikasi
Sebagai contoh beberapa spesifikasi raw material belum sesuai ketentuan terkini. |
m |
CA |
Update buku kompendial terbaru |
Suci Rahmawati; Erlinda; Rachma Yuliana |
30 Sep 2022 |
Open |
Detail |
| 22-0442-D |
E |
Audit BPOM 2021
Belum memiliki buku kompendial terbaru misal Farmakope Indonesia VI dan buku standar terkini lainnya misal USP, BP, dll untuk memastikan pemutakhiran spesifikasi
Sebagai contoh beberapa spesifikasi raw material belum sesuai ketentuan terkini:
|
m |
CA |
Implementasi revisi spesifikasi raw material |
Suci Rahmawati; Erlinda; Rachma Yuliana |
30 Apr 2023 |
Open |
Detail |
| 22-0443-D |
E |
Audit bPOM 2021
Baku pembanding tidak tersedia untuk alkohol (#004-0043-9), Maleic acid, Diamine analog, Chlorpheniramine related compound B, Chlorpheniramine related compound C, Chlorpheniramine, Pheniramine, Chlorpheniramine nitrile |
m |
CA |
Menyediakan beberapa baku pembanding yang dipersyaratkan sesuai buku kompendial terbaru |
Suci Rahmawati; Erlinda; Rachma Yuliana |
31 Mar 2023 |
Open |
Detail |
| 22-0444-D |
E |
Audit BPOM 2021
Baku pembanding tidak tersedia untuk alkohol (#004-0043-9), Maleic acid, Diamine analog, Chlorpheniramine related compound B, Chlorpheniramine related compound C, Chlorpheniramine, Pheniramine, Chlorpheniramine nitrile |
m |
CA |
Implementasi revisi spesifikasi raw material |
Suci Rahmawati; Erlinda; Rachma Yuliana |
30 Apr 2023 |
Open |
Detail |
| 22-0446-D |
E |
Audit BPOM 2021
Belum memiliki sistem identifikasi bakteri aerob, anaerob dan jamur
|
m |
CA |
Pemesanan/order reagen, alat yang dibutuhkan |
Suci Rahmawati; Erlinda; Rachma Yuliana |
30 Apr 2023 |
Open |
Detail |
| 22-0447-D |
E |
Audit BPOM 2021
Belum memiliki sistem identifikasi bakteri aerob, anaerob dan jamur |
m |
CA |
Melakukan uji identifikasi bakteri aerob, anaerob dan jamur jika hasil analisa sampel material dan finish good tidak memenuhi spesifikasi |
Suci Rahmawati; Erlinda; Rachma Yuliana |
31 May 2023 |
Open |
Detail |
| 24-0057-D |
E |
P&G Finding - QC & PD CAPA Remediation:
Please ensure that the correct handling of bulk product is followed. Especially since LOD is our issue. Yesterday we saw NB TOO and Dolo NB bulk product stored with 1 silica gel, while I understand the std supposed to be 3. NB Forte product follow correct procedure by placing 3 silica gel bags. |
m |
PA |
Improved metode training/sosialisasi BPR dilakukan di shift 1, 2 dan 3 |
SHAFA NABILAH; Kevin Dio Naldo
|
29 Feb 2024 |
Open |
Detail |
| 24-0069-D |
E |
P&G Finding - QC & PD CAPA Remediation:
Ladder for inkjet printing HM500 is placed above foil. Contamination risk |
m |
PA |
Create PoR for improve lay out HM500
|
Mujino |
29 Feb 2024 |
Open |
Detail |
| 24-0076-C |
I |
Assessment 2024
Material Receiving - Truck Inspection
RP-SOP-21/03 Penanganan Bahan Baku di Warehouse
RP-SOP-22/01 Penanganan Bahan Baku pada sistem SAP
Checlist Penerimaan Bahan Baku / Bahan Kemas
|
m |
CA |
Revisi SOP Penanganan Bahan Baku di Warehouse RP-SOP-21/xx untuk mengganti lampiran checklist bahan baku/bahan kemas pada lampiran |
Maria Euphrasia |
30 Mar 2024 |
Open |
Detail |
| 24-0076-C |
I |
Assessment 2024
Material Receiving - Truck Inspection
RP-SOP-21/03 Penanganan Bahan Baku di Warehouse
RP-SOP-22/01 Penanganan Bahan Baku pada sistem SAP
Checlist Penerimaan Bahan Baku / Bahan Kemas
|
m |
PA |
Training SOP Setelah revisi |
Maria Euphrasia |
30 Mar 2024 |
Open |
Detail |
| 24-0077-C |
I |
Assessment 2024
Material Receiving-Material Cleaning
RP-SOP-21/03 Penanganan Bahan Baku di Warehouse
RP-SOP-22/01 Penanganan Bahan Baku pada sistem SAP
GAPS - SOP point 1.14 does not mention clearly method for cleaning container of the material
|
m |
CA |
Revisi SOP Penanganan Bahan Baku di Warehouse RP-SOP-21/xx terkait detail deskripsi cara pembersihan bahan baku sebelum masuk ke Gudang. |
Maria Euphrasia |
30 Mar 2024 |
Open |
Detail |
| 24-0077-C |
I |
Assessment 2024
Material Receiving-Material Cleaning
RP-SOP-21/03 Penanganan Bahan Baku di Warehouse
RP-SOP-22/01 Penanganan Bahan Baku pada sistem SAP
GAPS - SOP point 1.14 does not mention clearly method for cleaning container of the material
|
m |
PA |
Training SOP Setelah revisi |
Maria Euphrasia |
30 Mar 2024 |
Open |
Detail |
| 24-0070-D |
E |
P&G Finding - QC & PD CAPA Remediation:
Ladder for inkjet printing HM500 is placed above foil. Contamination risk |
m |
PA |
Re-lay inkjet printer rack and create new access for inkjet printer |
Mujino |
29 Mar 2024 |
Open |
Detail |
| 24-0071-D |
E |
P&G Finding - QC & PD CAPA Remediation:
Below observation taken from trial Neurobion TOO EB6 (24-0007) Lot 2 & Lot 3 Final Mixing, Tableting, and Film Coating (22 Jan - 2 Feb 24) :
Found plastic pieces inside 2nd coating suspension tank wall. Contamination risk and could potentially block the spray system if plastic pieces got sucked into spraying system. Need to ensure how to prevent this.
|
m |
PA |
Coating solution setelah dibuat didiamkan selama 10 jam dalam SS container yang tertutup rapat menggunakan tutup SS.
Note : Perlu dibuktikan jika didiamkan dalam kondisi tertutup rapat tetap bisa menghilangkan foam |
Mardi; Befri Sidiki; Sopian Hadi
|
08 Mar 2024 |
Open |
Detail |
| 24-0078-C |
I |
Assessment 2024
Material Receiving-Receiving Record
RP-SOP-21/03 Penanganan Bahan Baku di Warehouse
RP-SOP-22/01 Penanganan Bahan Baku pada sistem SAP
GAPS - There is an email to inform that who will use 3 users access in each shift. However there is no prove that this arrangement has been followed rigorously. QRA is not established to access risk of this arrengament |
m |
CA |
Pembuatan QRA untuk pemakaian bersama user di warehouse |
Maria Euphrasia |
30 Apr 2024 |
Open |
Detail |
| 24-0071-D |
E |
P&G Finding - QC & PD CAPA Remediation:
Below observation taken from trial Neurobion TOO EB6 (24-0007) Lot 2 & Lot 3 Final Mixing, Tableting, and Film Coating (22 Jan - 2 Feb 24) :
During lightning stirrer set up, found particles fall from shaft into suspension. Contamination risk. Need to ensure how to prevent this. Need to have a good Cleanining, Inspection, and Lubrication for the stirrer. |
m |
PA |
Revisi SOP Pembersihan Lightnin Stirrer dan Form Verifikasi Kebersihan Lightnin Stirrer dan Sosialisasi setelah revisi SOP |
MARDI; IWAN NURIHWANI; SOPANDI; Befri Hadi Sidiki; Novensius Dillen; Rahmat Hastomo
|
08 Mar 2024 |
Open |
Detail |
| 24-0079-C |
I |
Assessment 2024
Material Storing - Location Assignment
RP-SOP-21/03 Penanganan Bahan Baku di Warehouse
RP-SOP-22/01 Penanganan Bahan Baku pada sistem SAP
GAPS - Repeated Obeservation : Material location in SAP is different with actual. |
m |
PA |
Refreshment ke Personil untuk regular menyesuaikan lokasi aktual dengan sistem SAP |
Maria Euphrasia |
08 Mar 2024 |
Open |
Detail |
| 22-0452-D |
E |
Audit BPOM 2021
Growth promotion test tidak mencakup uji identifikasi bakteri spesifik |
m |
PA |
Melakukan pembelian software microbial ID system |
Suci Rahmawati; Erlinda; Rachma Yuliana |
31 Jul 2023 |
Open |
Detail |
| 22-0459-D |
E |
Audit BPOM 2021
Terdapat perbedaan tekanan yang tidak sesuai syarat (tidak mencapai 10 Pa), misal ruang tabletting 7 R065, ruang antara barang untuk bahan kemas, ruang stripping 2 R. |
m |
PA |
Melakukan studi interval pembersihan return grill.
|
MARDI; SETIO HARMONO; Ricko Aditya; Arga Wahyu Hidayat |
30 Apr 2022 |
Open |
Detail |
| 24-0102-C |
I |
CAPA of QC internal audit in 2023 is not yet established until 19 Jan 2024 |
M |
CA |
1. Improve method to provide observation result by conduct meeting with auditors after self inspection |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
14 Mar 2024 |
Open |
Detail |
| 24-0118-C |
I |
Column of risk factor or residual risk has risk reduction title |
m |
CA |
1. Revise form Risk Register QA-F-427/01 to revise risk reduction column and training after revise |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
14 Mar 2024 |
Open |
Detail |
| 24-0119-C |
I |
Risk Register for FG Release is not using standard format (no document number & typo error in risk reduction tittle |
m |
CA |
1. Refreshment training template Risk Register QA-F-427 to all related personnel |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
14 Mar 2024 |
Open |
Detail |
| 24-0120-C |
I |
Reconciliation only done until product distribution to APL branches instead of outlet such as apotek, Indomaret/alfamart. Etc |
m |
CA |
1. Revise SOP QA5-SOP-242/05 by adding the detail to perform reconciliation until outlet such as apotek, indomaret/alfamart. Etc on for mock up recall activity product |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
30 Apr 2024 |
Open |
Detail |
| 24-0120-C |
I |
Reconciliation only done until product distribution to APL branches instead of outlet such as apotek, Indomaret/alfamart. Etc |
m |
CA |
2. Training procedure after revised |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
30 Apr 2024 |
Open |
Detail |
| 24-0121-C |
I |
Complaint report format did not contain following item as reminder what point to be checked during investigation
- Batch Record Evaluation
- Repeated Complaint
- Personnel Training evaluation
- Preventive Maintenance Evaluation
- etc (refer to CTRP Complaint Report) |
M |
CA |
1. Revise attachment 8.1 SOP QA3-SOP-293/04 (investigation report template) by adding system that need to be evaluated for complaint investigation |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
30 Apr 2024 |
Open |
Detail |
| 24-0121-C |
I |
Complaint report format did not contain following item as reminder what point to be checked during investigation
- Batch Record Evaluation
- Repeated Complaint
- Personnel Training evaluation
- Preventive Maintenance Evaluation
- etc (refer to CTRP Complaint Report)
|
M |
CA |
2. Training procedure after revised |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
30 Apr 2024 |
Open |
Detail |
| 24-0122-C |
I |
SOP mentions that complete should be responsed within 24 hours however, there is no procedure on how to give the response |
m |
CA |
1. Revise SOP QA3-SOP-293/04 by adding the detail how to give the response to source of complaint |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
30 Apr 2024 |
Open |
Detail |
| 24-0122-C |
I |
SOP mentions that complete should be responsed within 24 hours however, there is no procedure on how to give the response |
m |
CA |
2. Training procedure after revised |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
30 Apr 2024 |
Open |
Detail |
| 24-0123-C |
I |
Root cause analysis is not done properly (example QDR No 4-23-0508 (Neozep Forte tablet cracking). There is no clear connection between defect and root cause and not all aspect is reviewed such as man & method. It is recommended to use RCA tools during investigation such as fishbone, why-why analysis etc |
M |
CA |
1. Revise form QDR (QA-F-185/xx) by adding the detail aspect investigation detail |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
25 Apr 2024 |
Open |
Detail |
| 24-0123-C |
I |
Root cause analysis is not done properly (example QDR No 4-23-0508 (Neozep Forte tablet cracking). There is no clear connection between defect and root cause and not all aspect is reviewed such as man & method. It is recommended to use RCA tools during investigation such as fishbone, why-why analysis etc |
M |
CA |
2. Training procedure after revised |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
30 Apr 2024 |
Open |
Detail |
| 24-0038-C |
I |
Assessment 2024
CoA of Knive Guide Strip Sangobion QC No AW120219M is not reviewed as per SOP requirement
|
M |
PA |
Revisi SOP Penerimaan bahan pengemas |
Muhammad Ferdiansyah; Sentia Agestina |
31 Mar 2024 |
Open |
Detail |
| 24-0041-C |
I |
Assessment 2024
Most of defect has no visual standard (target, acceptable, marginal and unacceptable defect) to be used by inspector & operator. |
m |
PA |
Continue for provide visual defect standard using formal document |
SENTIA AGESTINA |
01 Feb 2024 |
Open |
Detail |
| 24-0043-C |
I |
Assessment 2024
There is no procedure how to take and store intermediate sample for microbial testing |
m |
CA |
Revise procedur Inspeksi Pengemasan Primer (QC4-SOP-179/07) with additional plastic as sampling container for microbial limit test (and other P&G sample) |
SENTIA AGESTINA |
31 Mar 2024 |
Open |
Detail |
| 24-0098-C |
I |
The SOP state that monitoring should be done monthly and cover BPOM, PICS & WHO regulation. However, for PCIS and WHO is not checked on monthly basis. |
m |
CA |
1. Revise Form QA-F-447/01 by adding tools to ensure all source of guideline has been assessed |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
14 Apr 2024 |
Open |
Detail |
| 24-0098-C |
I |
The SOP state that monitoring should be done monthly and cover BPOM, PICS & WHO regulation. However, for PCIS and WHO is not checked on monthly basis. |
m |
CA |
2. Training form after revised |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
14 Apr 2024 |
Open |
Detail |
| 24-0105-C |
I |
Some failure mode is not registered in Risk Register Report No RR/PD/001/01. Example, there is no equipment failure mode which can lead to box without coding |
m |
CA |
2. Revise RR/PD/001/01 by adding equipment failure mode which can lead to box without coding |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
14 Apr 2024 |
Open |
Detail |
| 24-0106-C |
I |
Risk Register is not yet done for coating process in production |
m |
CA |
2. Revise RR/PD/001/01 by adding equipment by adding all process |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
14 Apr 2024 |
Open |
Detail |
| 24-0035-C |
I |
Assessment 2024
Next compressing process has been run on 21 Dec 2023 before Semi Finished Good recommendation disposition (Neozep Tab MO no 233116) is given by QC supervisor on 22 Dec 2023. Testing has been done on 14 Dec 2023 |
m |
PA |
Revise procedur In Process Control & Disposisi Semi Finished Good (QC4-SOP-182/08) with additional procedure 2nd review by other QCI for product that in line running in 2nd, 3rd, holiday. |
SENTIA AGESTINA |
31 Mar 2024 |
Open |
Detail |
| 24-0036-C |
I |
Assessment 2024
There are visual defect standard for black spot on capsule & etc however it does not use formal document. Procedure to prepare visual defect standard is not yet available
|
m |
CA |
Revise SOP In Process Control and provide new form as formal document for visual defect standard for capsule
|
SENTIA AGESTINA |
31 Mar 2024 |
Open |
Detail |
| 24-0037-C |
I |
Assessment 2024
There are visual defect standard for black spot on capsule & etc however it does not use formal document. Procedure to prepare visual defect standard is not yet available |
M |
PA |
Revise SOP In Process Control and provide new form as formal document for visual defect standard for others defects |
SENTIA AGESTINA |
31 Mar 2024 |
Open |
Detail |
| 24-0039-A |
I |
Assessment 2024
Personal training Record of Dhimas A.P is not yet updated with training other than Quality Mindset & Data Integrity |
m |
PA |
Memeriksa apakah training record personel lainnya lengkap |
Muhammad Ferdiansyah; Sentia Agestina |
29 Feb 2024 |
Open |
Detail |
| 24-0040-A |
I |
Assessment 2024
There is no operational & Cleaning procedure of Digimatic Caliper & Micrometer |
M |
CA |
Pembuatan SOP pengoperasian Alat testing |
Leni Herlina; Sentia Agestina |
31 Mar 2024 |
Open |
Detail |
| 22-0453-D |
E |
Audit BPOM 2021
Growth promotion test tidak mencakup uji identifikasi bakteri spesifik |
m |
PA |
Pembelian microscop Euromex |
Suci Rahmawati; Erlinda; Rachma Yuliana |
31 Jul 2023 |
Open |
Detail |
| 22-0454-D |
E |
Audit BPOM 2021
Growth promotion test tidak mencakup uji identifikasi bakteri spesifik |
m |
PA |
Pembelian reagen |
Suci Rahmawati; Erlinda; Rachma Yuliana |
31 Jul 2023 |
Open |
Detail |
| 22-0455-D |
E |
Audit BPOM 2021
Growth promotion test tidak mencakup uji identifikasi bakteri spesifik |
m |
PA |
Pembelian media |
Suci Rahmawati; Erlinda; Rachma Yuliana |
31 Jul 2023 |
Open |
Detail |
| 24-0099-C |
I |
Importing countries regulation change review (such as Phillipines, Malaysia, Singapore etc) are not part of the SOP |
M |
CA |
1. Revise SOP QA6-SOP-328/01 by adding provision to conduct monitoring regulation assessment for export countries (ask requested by export countries |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
14 Apr 2024 |
Open |
Detail |
| 24-0099-C |
I |
Importing countries regulation change review (such as Phillipines, Malaysia, Singapore etc) are not part of the SOP |
M |
CA |
2. Training SOP after revised |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
14 Apr 2024 |
Open |
Detail |
| 24-0103-C |
I |
Internal audit, customer satisfaction, risk & opportunity, resource adequacy, external parties evaluation, and action from previous management review are not part of 2023 review (2022 data) |
m |
CA |
2. Training SOP after revised |
ENDAH SRI UTAMI |
31 Mar 2024 |
Open |
Detail |
| 23-0331-D |
E |
Cross Audit DVL 2023
There is a 70% alcohol spray in the dispensary area, with an expiration date of 3 months. However, based on the study report determining the expiry date of the 70% alcohol solution after Doc. No. was made. QA-EDR-ALK/01 (Date 8 Dec 2021) and Procedure for making 70% dilute alcohol (QC3-SOP-48/03, 21 Oct 2022) are stated to have an expiration date of 7 days after being made. |
M |
PA |
Revise SOP related to expiry date cleaning solution, if required based on result poin 1 |
MAESAROH; Maria Euphrasia |
15 Jul 2023 |
Open |
Detail |
| 23-0332-D |
E |
Cross Audit DVL 2023
The scoop used for dispense materials was not dedicated, it is necessary to carry out a cleaning validation matrix and ensure cleaning validation |
m |
CA |
Prepare cleaning validation protocol including matrix of raw material for cleaning validation of weighing tools (scoop)
|
QA VALIDATION |
30 Jun 2023 |
Open |
Detail |
| 23-0334-D |
E |
Cross Audit DVL 2023
Acceptance criteria of cleaning validation should be documented on protocol related to quantity batch needed |
m |
CA |
Training the revised SOP to related personnel |
QA VALIDATION |
10 Jun 2023 |
Open |
Detail |
| 23-0335-D |
E |
Cross Audit DVL 2023
In the cabinet for sample storage, temperature monitoring include in the instrument room monitoring which not include MIN and MAX themperature per day. |
C |
CA |
Training SOP after revised |
QA VALIDATION |
08 Jul 2023 |
Open |
Detail |
| 24-0042-C |
I |
Assessment 2024
Inspector write zigzag mark instead 0 on the record when defect is not found. In documentation SOP zigzag mark is written for empty cell. |
m |
PA |
Check & revise to other inspection report |
SENTIA AGESTINA |
31 Mar 2024 |
Open |
Detail |
| 24-0058-D |
E |
P&G Finding - QC & PD CAPA Remediation:
As per heads up to the team yesterday, the humidity in the room is really concerning. Although we understand that fluctuation will be happened during operation run, but the level of humidity reached is way too high vs std ≤70%. Actual reading at that time was 76% and 72.7% (correction factor -4). And there was a record of max humidity in the device reached until 82.9%. I would like to understand the control of humidity in storage area. |
m |
PA |
Installing a heater and flow sensor on the HVAC line to room R.046 |
ACHMAD KURNIAWAN |
29 Mar 2024 |
Open |
Detail |
| 24-0060-D |
E |
P&G Finding - QC & PD CAPA Remediation:
Insect (fly) still found in visitor locker area on 14th Dec’23. |
m |
PA |
Resocialization to employee regarding opening and closing the glass door |
MILDA NETTY, Muhammad Aulia Amri |
29 Feb 2024 |
Waiting RFE Approval by Dept Head |
Detail |
| 24-0064-D |
E |
P&G Finding - QC & PD CAPA Remediation:
What is the correct labelling information?
Some part are kept blank in the label: inspected by, date, verification by leader (this one just written directly by team when we were asking yesterday if this part should be filled in or not). I supposed inspection and verification activity need to be happened and acknowledge before sending this bulk to WIP storage? If yes, why it is not confirmed in label information? |
m |
PA |
Training ulang label identification tag ke semua personnel di semua area produksi.
NOTE : Training area compounding DONE |
MARDI; SETIO HARMONO; Ricko Aditya; Arga Wahyu Hidayat |
23 Feb 2024 |
Open |
Detail |
| 24-0080-C |
I |
Assessment 2024
Stock Accuracy Monitoring-RP-SOP-09/04 Stok Take
GAPS - Stock take is not executed as per RP-SOP-09/4. Raw data of this stock take is not available. Discrepancy report has no document number and the format is different with RP-F-24/XX |
m |
CA |
2. Memperbaiki format form RP-F-24/xx menyesuaikan dengan lampiran SOP |
Maria Euphrasia |
28 Feb 2024 |
Open |
Detail |
| 24-0072-D |
E |
P&G Finding - QC & PD CAPA Remediation:
Below observation taken from trial Neurobion TOO EB6 (24-0007) Lot 2 & Lot 3 Final Mixing, Tableting, and Film Coating (22 Jan - 2 Feb 24) :
There was “fault pressure pneumatic seal end guards” alarm during the run. Suddenly inlet air volume dropped and then spray rate increased up to 200 gr/min, need to do trouble shooting. Need to understand rotocause on this and how to prevent this. |
m |
PA |
Melakukan penggantian infletable seal dengan yang baru |
Mujino |
31 May 2024 |
Open |
Detail |
| 24-0073-D |
E |
P&G Finding - QC & PD CAPA Remediation:
Below observation taken from trial Neurobion TOO EB6 (24-0007) Lot 2 & Lot 3 Final Mixing, Tableting, and Film Coating (22 Jan - 2 Feb 24) :
There was “fault pressure pneumatic seal end guards” alarm during the run. Suddenly inlet air volume dropped and then spray rate increased up to 200 gr/min, need to do trouble shooting. Need to understand rotocause on this and how to prevent this. |
m |
PA |
Menetapkan periode penggantian berkala pada infletable seal mnejadi setahun sekali, dan dimasukkan di form PMT/revisi form PMT |
Mujino |
29 Feb 2024 |
Open |
Detail |
| 24-0074-D |
E |
P&G Finding - QC & PD CAPA Remediation:
Below observation taken from trial Neurobion TOO EB6 (24-0007) Lot 2 & Lot 3 Final Mixing, Tableting, and Film Coating (22 Jan - 2 Feb 24) :
There was “fault pressure pneumatic seal end guards” alarm during the run. Suddenly inlet air volume dropped and then spray rate increased up to 200 gr/min, need to do trouble shooting. Need to understand rotocause on this and how to prevent this. |
m |
PA |
Training form PMT setelah revisi |
Mujino |
08 Mar 2024 |
Open |
Detail |
| 24-0081-C |
I |
Assessment 2024
Temperature & RH Control & Monitoring - QA7-SOP-223/12 Monitoring Ruangan
GAPS - Maximum temperature / RH data is only downloaded monthly. This risk that any OOS before or after T/RH daily checking cannot be detected immediately. There is no downloaded data of RM-WH for Oct & Dec 2023. RH is OOS on 25 Nov 23 starting 19.00 up to 26 Nov 23 07.00 and no QDR issued for this event |
m |
CA |
1. Penggunaan thermohygro & data logger untuk meminimalkan risiko agar data oos cepat diketahui (melalui min/max dalam 24 jam di thermohygrometer. |
Maria Euphrasia |
04 Mar 2024 |
Open |
Detail |
| 24-0088-D |
E |
P&G Finding - QC & PD CAPA Remediation:
MTU provide sample quantity to QC not as per-plan for EB Neurobion TOO 240007 (27Jan24) |
m |
PA |
Revise SOP Pilot scale trial to add requirement sampling plan & Sosialisasi setelah revisi SOP |
SHAFA NABILAH; Kevin Dio Naldo
|
15 Mar 2024 |
Open |
Detail |
| 24-0089-D |
E |
P&G Finding - QC & PD CAPA Remediation:
MTU provide sample quantity to QC not as per-plan for EB Neurobion TOO 240007 (27Jan24) |
m |
PA |
Prepare sampling plan for next EB
|
SHAFA NABILAH; Kevin Dio Naldo
|
15 Mar 2024 |
Open |
Detail |
| 24-0100-C |
I |
Checklist Internal Audit does not yet contain requirement of computerized system and data integrity |
m |
CA |
1. Revise checklist internal audit by adding requirement of computerized system and data integrity |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
14 Apr 2024 |
Open |
Detail |
| 24-0100-C |
I |
Checklist Internal Audit does not yet contain requirement of computerized system and data integrity |
m |
CA |
2. Training checklist audit after revised |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
14 Apr 2024 |
Open |
Detail |
| 24-0103-C |
I |
Internal audit, customer satisfaction, risk & opportunity, resource adequacy, external parties evaluation, and action from previous management review are not part of 2023 review (2022 data) |
m |
CA |
1. Revise SOP Management review by adding provision |
ENDAH SRI UTAMI |
31 Mar 2024 |
Open |
Detail |
| 23-0335-D |
E |
Cross Audit DVL 2023
RH specification in the weighing room is NMT 80%. Based on balance supplier, recommendation RH spec for weighing room are 40% - 60%,since the high RH can impact to hygroscopic materils |
M |
CA |
Prepare data history monitoring temperature & RH for weighing room |
Suci Rahmawati; Erlinda; Rachma Yuliana |
01 May 2023 |
Open |
Detail |
| 23-0335-D |
E |
Cross Audit DVL 2023
RH specification in the weighing room is NMT 80%. Based on balance supplier, recommendation RH spec for weighing room are 40% - 60%,since the high RH can impact to hygroscopic materils |
M |
CA |
Discuss with Engineer/technician from equipment supplier, related to specific temperature & RH requirement for weighing room |
Suci Rahmawati; Erlinda; Rachma Yuliana |
30 Jun 2024 |
Open |
Detail |
| 23-0335-D |
E |
Cross Audit DVL 2023
There is no record for verification KF on 30 Mar 2023 |
m |
CA |
Check others instrument procedure which requires verification whether already stated procedure to record verification result |
Suci Rahmawati; Erlinda; Rachma Yuliana |
17 Jun 2023 |
Open |
Detail |
| 23-0335-D |
E |
Cross Audit DVL 2023
There is no record for verification KF on 30 Mar 2023 |
m |
CA |
Revise SOP based on checking result point d1 if required. |
Suci Rahmawati; Erlinda; Rachma Yuliana |
15 Jul 2023 |
Open |
Detail |
| 24-0066-D |
E |
P&G Finding - QC & PD CAPA Remediation:
What is the correct labelling information?
Some part are kept blank in the label: inspected by, date, verification by leader (this one just written directly by team when we were asking yesterday if this part should be filled in or not). I supposed inspection and verification activity need to be happened and acknowledge before sending this bulk to WIP storage? If yes, why it is not confirmed in label information? |
m |
PA |
- Training ulang label identification tag ke semua personnel di semua area produksi.
NOTE : Training area compounding DONE |
Mardi; Befri Sidiki; Sopian Hadi
|
23 Feb 2024 |
Open |
Detail |
| 24-0067-D |
E |
P&G Finding - QC & PD CAPA Remediation:
What is the correct labelling information?After taking out the qty from bulk drum, what is the correct approach for labelling information? Label should be changed to a new one or just update the information in previous label? In below pict, there is a mark of 14.74 (with blue ballpoint) which I supposed is the remaining net qty inside drum. However, there is no clear information as there is no unit (kg), gross weight not updated, and no information when this qty is taken and who took it. |
m |
PA |
Membuat prosedur penanganan granule intermediate, termasuk pencatatan jika ada pemakaian dan Training SOP |
MARDI; IWAN NURIHWANI; SOPANDI; Befri Hadi Sidiki; Novensius Dillen; Rahmat Hastomo
|
31 Mar 2024 |
Open |
Detail |
| 24-0068-D |
E |
P&G Finding - QC & PD CAPA Remediation:
There is a green sticker “tested ok” on B12 1% PV6 for Thai export. While the actual status of bulk is still under quarantine. According to information from the team, this might be a status for drum packaging itself. However, what should be the right approach for this green sticker? Should it be removed to prevent dispute information on release status of bulk? |
m |
PA |
Revisi SOP Cara Membersihkan dan Menentukan Layak Pakai Wadah Produk Anatra dan Ruahan (PD-SOP-44/07) menambahkan ketentuan memastikan "kriteria bersih" termasuk bebas dari label sebelumnya dan Training SOP setelah revisi |
MARDI; IWAN NURIHWANI; SOPANDI; Befri Hadi Sidiki; Novensius Dillen; Rahmat Hastomo
|
22 Mar 2024 |
Open |
Detail |
| 22-0451-D |
E |
Audit BPOM 2021
Ruang lingkup belum mencakup semua alat hanya HPLC yang menggunakan Chromeleon. Tidak mencakup High Pressure Liquid Chromatography spreadsheet (assay Alaxan, New Enzyplex Forte, Decolgen Forte dll), alat Atomic Absortion Spectrometry, dll |
m |
PA |
Upgrade instrument yang belum terinstal audit traill |
Suci Rahmawati; Erlinda; Rachma Yuliana |
31 Jul 2023 |
Open |
Detail |
| 22-0456-D |
E |
Audit BPOM 2021
Protap Validasi Pembersihan No. QA7-SOP-251/05 tanggal 2 Juli 2021 belum mempertimbangkan parameter PDE untuk menetapkan batasan residu produk |
m |
PA |
Membeli data PDE ke pihak ketiga |
QA VALIDATION |
31 Aug 2023 |
Open |
Detail |
| 22-0457-D |
E |
Audit BPOM 2021
Protap Validasi Pembersihan No. QA7-SOP-251/05 tanggal 2 Juli 2021 belum mempertimbangkan parameter PDE untuk menetapkan batasan residu produk |
m |
PA |
Revisi SOP Validasi Pembersihan (QA7-SOP-251/05) untuk menambahkan parameter PDE untuk menetapkan batasan residu produk |
QA VALIDATION |
30 Sep 2023 |
Open |
Detail |
| 22-0458-D |
E |
Audit BPOM 2021
Protap Validasi Pembersihan No. QA7-SOP-251/05 tanggal 2 Juli 2021 belum mempertimbangkan parameter PDE untuk menetapkan batasan residu produk |
m |
PA |
Melakukan Validasi Pembersihan menggunakan parameter PDE |
QA VALIDATION |
29 Feb 2024 |
Open |
Detail |
| 22-0460-D |
E |
Audit BPOM 2021
Terdapat proses yang masih manual yaitu proses pre blending Corn Starch dan Povidone K-30 menggunakan plastic bag |
m |
PA |
Melakukan revisi BPR dengan memuat ukuran plastic bag yang detail dan waktu mixing manual agar menjadi terstandarisasi untuk setiap aktivitas pre-blending dari Povidone K-30 dan Corn Starch, dan sudah diimplementasikan pada pembuatan BPR produk baru. |
MARDI; IWAN NURIHWANI; SOPANDI; Befri Hadi Sidiki; Novensius Dillen; Rahmat Hastomo
|
31 Dec 2022 |
Open |
Detail |
| 22-0461-D |
E |
Audit BPOM 2021
Belum tersedia prosedur yang mengatur penempatan dehumidifier portable di ruangan produksi pada saat digunakan, mengingat posisi dehumidifier portable dapat mempengaruhi nilai RH |
m |
PA |
Buat penandaan untuk penempatan dehumidifier berdasarkan hasil validasi
|
MARDI; SETIO HARMONO; Ricko Aditya; Arga Wahyu Hidayat |
30 Sep 2022 |
Open |
Detail |
| 24-0165-D |
E |
CAPA Vendor Audit Tigaka |
m |
CA |
CAPA Vendor Audit Tigaka - Refer to audit report |
Kiki Zakiah |
07 Jun 2024 |
Open |
Detail |