CAPA/GMP/21/0008 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
14 Dec 2021 |
CAPA Close |
Detail |
24-0101-C |
I |
CAPA Closing of Data Integrity Assessment in May & June 2023 is less than 20% |
M |
CA |
2. Reactivate CAPA system |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
29 Feb 2024 |
CAPA Close |
Detail |
24-0102-C |
I |
CAPA of QC internal audit in 2023 is not yet established until 19 Jan 2024 |
M |
CA |
2. Refreshment training SOP Inspeksi Diri to auditors to submit observation result after audit |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
31 Mar 2024 |
CAPA Close |
Detail |
24-0104-C |
I |
In Risk Register Report No RR/PD/001/01, some severity number can be reduced by implementing action which actually no impact on severity if this action still fail. Example in weighing process with failure mode wrong weight quantity and action is implement check & second check, the severity is reduced from 3 to 2. Actually this action can reduce the probability & detectability, while the severity remain the same if it is still fail |
m |
CA |
1. Refreshment training SOP QA1-SOP-268/07 to all related personnel related to risk priority number |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
31 Mar 2024 |
CAPA Close |
Detail |
24-0106-C |
I |
Risk Register is not yet done for coating process in production |
m |
CA |
1. Refreshment training SOP QA1-SOP-268/07 to all personnel related to initiation and assessment of RR |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
31 Mar 2024 |
CAPA Close |
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 |
1. Refreshment training SOP QA1-SOP-268/07 to all related personnel related to initiation and assessment of RR |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
31 Mar 2024 |
CAPA Close |
Detail |
24-0101-C |
I |
CAPA Closing of Data Integrity Assessment in May & June 2023 is less than 20% |
M |
CA |
1. Refreshment training SOP Manajemen CAPA to all related personnel to submit evidence CAPA to QA Compliance |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
31 Mar 2024 |
CAPA Close |
Detail |
24-0102-C |
I |
CAPA of QC internal audit in 2023 is not yet established until 19 Jan 2024 |
M |
CA |
3. Refreshment training SOP Inspeksi Diri to QA Compliance to prepare CAPA audit report |
HANI AFIFAH, QA Compliance, Firda Aulia Rahman |
31 Mar 2024 |
CAPA Close |
Detail |
22-0433-D |
E |
Audit Unilab tahun 2022
Binder software used to monitor the storage condition of stability chambers was not validated. |
M |
CA |
Provide Performance Qualification Report Binder Software |
Familia Maya Sari, Suci Rahmawati |
30 Apr 2023 |
CAPA Close |
Detail |
22-0440-D |
E |
Audit Unilab tahun 2022
Lapses in the handling of stability chamber malfunction were noted, based on DR-4-22-0094:
Relative humidity readings outside the specification of 75 ± 5% were noted on April 15, 2022, but deviation was raised only on April 25, 2022;
|
M |
CA |
Conduct QRA related to stability sample which have been exposed due to broken chamber |
Familia Maya Sari, Suci Rahmawati |
14 Dec 2022 |
CAPA Close |
Detail |
22-0440-D |
E |
Lapses in the handling of stability chamber malfunction were noted, based on DR-4-22-0094:
The reliability of the stability samples which have been exposed to fluctuations in %RH for 14 days was not justified.
|
M |
CA |
Revise SOP Pengoperasian Climatic Chamber dan Penanganan Sampel Uji Stabilitas dalam Climatic Chamber (QC5-SOP-209/xx) by adding conduct assessment on stability sample which have been exposed. |
Familia Maya Sari, Suci Rahmawati |
13 Jan 2023 |
CAPA Close |
Detail |
22-0440-D |
E |
Audit Unilab tahun 2022
Lapses in the handling of stability chamber malfunction were noted, based on DR-4-22-0094:
The reliability of the stability samples which have been exposed to fluctuations in %RH for 14 days was not justified.
|
M |
PA |
Socialization SOP "QC5-SOP-209/xx" after revised. |
Familia Maya Sari, Suci Rahmawati |
20 Jan 2023 |
CAPA Close |
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 |
Conduct cleaning sampling tools in the cleaning tools room in Dispensing Area |
Leni Herlina; Sentia Agestina |
01 Jun 2023 |
CAPA Close |
Detail |
CAPA/GMP/21/0012 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
Leni Herlina; Sentia Agestina |
14 Dec 2021 |
CAPA Close |
Detail |
22-0439-D |
E |
Audit Unilab tahun 2022
Cleaning of sampling tools was carried out in the same room where the LAF is located. Meanwhile, liquid pumps are washed in the sink located at the gowning area |
M |
CA |
Follow-up question:
Kindly provide photo of the washing area for further evaluation. How do you ensure that washing of the tools do not pose any risk of contamination or cross-contamination?
|
Leni Herlina; Sentia Agestina |
31 May 2023 |
CAPA Close |
Detail |
CAPA/GMP/21/0011 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
SENTIA AGESTINA |
14 Dec 2021 |
CAPA Close |
Detail |
CAPA/GMP/21/0013 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
Maria Euphrasia |
14 Dec 2021 |
CAPA Close |
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 |
CA |
Menyesuaikan lokasi aktual sesuai dengan SAP |
Maria Euphrasia |
12 Feb 2024 |
CAPA Close |
Detail |
22-0438-D |
E |
Audit Unilab tahun 2022
There was no designated area for rejected flammable materials. |
m |
CA |
Follow-up questions:
•Where is this rejected area located exactly?
•What are the control measures to ensure security and fire safety?
|
Maria Euphrasia |
31 May 2023 |
CAPA Close |
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 |
1. Refreshment SOP Stock Take untuk semua personil warehouse |
Maria Euphrasia |
28 Feb 2024 |
CAPA Close |
Detail |
22-0438-D |
E |
Audit Unilab tahun 2022
There was no designated area for rejected flammable materials. |
m |
CA |
Initiate change control related to additional rejected area for flammable |
Maria Euphrasia |
21 Mar 2023 |
CAPA Close |
Detail |
CAPA/GMP/21/0005 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
Rian Andriana |
14 Dec 2021 |
CAPA Close |
Detail |
CAPA/GMP/21/0002 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
Luthfi Khaerul Munandar |
14 Dec 2021 |
CAPA Close |
Detail |
CAPA/GMP/21/0017 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
ACHMAD KURNIAWAN |
14 Dec 2021 |
CAPA Close |
Detail |
22-0438-D |
E |
Audit Unilab tahun 2022
There was no designated area for rejected flammable materials.
|
m |
CA |
Revise layout of warehouse area |
ACHMAD KURNIAWAN |
31 Mar 2023 |
CAPA Close |
Detail |
CAPA/GMP/21/0003 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
Mujino |
14 Dec 2021 |
CAPA Close |
Detail |
CAPA/GMP/21/0001 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021 |
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance |
MAESAROH; Maria Euphrasia |
14 Dec 2021 |
CAPA Close |
Detail |
23-0327-D |
E |
Cross Audit DVL 2023
Fire extinguishers in the Material Receiving Buffer area are blocked by pallets. |
m |
CA |
Refreshment SOP (HS-SOP-19/02) do not store/put material near fire extinguisher |
MAESAROH; Maria Euphrasia |
20 May 2023 |
CAPA Close |
Detail |
23-0327-D |
E |
Cross Audit DVL 2023
Fire extinguishers in the Material Receiving Buffer area are blocked by pallets. |
m |
CA |
put up a prohibition sign in front of the fire extinguisher |
MAESAROH; Maria Euphrasia |
20 May 2023 |
CAPA Close |
Detail |
23-0340-D |
E |
Cross Audit DVL 2023
In weighing booth number 1, the design table is a porous table, dust was trapped and difficult to clean. |
m |
CA |
Training SOP after revised |
MAESAROH; Maria Euphrasia |
30 Jun 2023 |
CAPA Close |
Detail |
23-0340-D |
E |
Cross Audit DVL 2023
In weighing booth number 1, the design table is a porous table, dust was trapped and difficult to clean. |
m |
CA |
Revision of the Weighing SOP related to improve the method of cleaning dirt that is difficult to clean on the weighing table |
MAESAROH; Maria Euphrasia |
30 Jun 2023 |
CAPA Close |
Detail |
23-0340-D |
E |
Cross Audit DVL 2023
In weighing booth number 1, the design table is a porous table, dust was trapped and difficult to clean. |
m |
PA |
Check all equipment/area that dfficult to cleaning process |
MAESAROH; Maria Euphrasia |
30 Jun 2023 |
CAPA Close |
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 |
Perform study of expiry date cleaning solution, if required based on checking poin 1 |
MAESAROH; Maria Euphrasia |
30 Jun 2023 |
CAPA Close |
Detail |
24-0056-D |
E |
P&G Finding - QC & PD CAPA Remediation:
Please help to seal back intermediate B12 right after use. Especially since this intermediate is a sensitive material. |
m |
PA |
Revisi SOP Penimbangan dengan memasukkan prosedur handling khusus untuk Intermediate B12 dan material lain yang perlu handling khusus dan Sosialisasi SOP setelah revisi |
MAESAROH; Maria Euphrasia |
22 Mar 2024 |
CAPA Close |
Detail |
23-0328-D |
E |
Cross Audit DVL 2023
The identity label (label ID SAP) on the white wax material (1R22-0094) is in broken condition |
m |
CA |
Revise SOP "handling material in warehouse"by adding material handling method to define the detail of checking label and material condition if any activities has been done on material. |
MAESAROH; Maria Euphrasia |
10 Jun 2023 |
CAPA Close |
Detail |
23-0328-D |
E |
Cross Audit DVL 2023
The identity label (label ID SAP) on the white wax material (1R22-0094) is in broken condition |
m |
CA |
Training SOP after revised |
MAESAROH; Maria Euphrasia |
17 Feb 2024 |
CAPA Close |
Detail |
23-0328-D |
E |
Cross Audit DVL 2023
The identity label (label ID SAP) on the white wax material (1R22-0094) is in broken condition |
m |
PA |
Check SOP Handling material in dispensing, related to handling material, wheter already state handling method to define the detail of checking label and material condition if any activities has been done on material. |
MAESAROH; Maria Euphrasia |
30 May 2023 |
CAPA Close |
Detail |
23-0330-D |
E |
Cross Audit DVL 2023
There is already a periodic provision for handpallet cleaning for the gray area (frequency: daily) referring to PD-L-24/02 (22 Jul 2022). However, when the dispensary was staged, there was a fairly dirty hand pallet, such as oil at the base of the handle.
|
m |
CA |
Revise SOP on How to Use a Handpallet (PD-SOP-101/xx) Perform Check by personil after repaired. |
MAESAROH; Maria Euphrasia |
10 Jun 2023 |
CAPA Close |
Detail |
23-0330-D |
E |
Cross Audit DVL 2023
There is already a periodic provision for handpallet cleaning for the gray area (frequency: daily) referring to PD-L-24/02 (22 Jul 2022). However, when the dispensary was staged, there was a fairly dirty hand pallet, such as oil at the base of the handle. |
m |
CA |
Training SOP after revised |
MAESAROH; Maria Euphrasia |
10 Jun 2023 |
CAPA Close |
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 |
Check all solutions used in Dispensing that have an expiry date and include study data. |
MAESAROH; Maria Euphrasia |
31 May 2023 |
CAPA Close |
Detail |
23-0340-D |
E |
Cross Audit DVL 2023
In weighing booth number 1, the design table is a porous table, dust was trapped and difficult to clean. |
m |
PA |
Improve cleaning method, if any required |
MAESAROH; Maria Euphrasia |
30 Jun 2023 |
CAPA Close |
Detail |
23-0328-D |
E |
Cross Audit DVL 2023
The identity label (label ID SAP) on the white wax material (1R22-0094) is in broken condition |
m |
PA |
Revise SOP Handling material in dispensing, if any required based on checking poin 1 |
MAESAROH; Maria Euphrasia |
10 Jun 2023 |
CAPA Close |
Detail |
23-0328-D |
E |
Cross Audit DVL 2023
The identity label (label ID SAP) on the white wax material (1R22-0094) is in broken condition |
m |
PA |
Revise SOP Handling material in dispensing, if any required based on checking poin 1 |
MAESAROH; Maria Euphrasia |
10 Jun 2023 |
CAPA Close |
Detail |
23-0329-D |
E |
Cross Audit DVL 2023
There is no identity label (label ID SAP) attached to the packaging Material calcium carbonate (TREX-00000006), on the original packaging (material received from DVL Gunung Putri). |
m |
CA |
Refreshment of SOP for Handling Raw Materials in the Warehouse, regarding the receiving raw material by improve training method by Post Test. |
MAESAROH; Maria Euphrasia |
30 May 2023 |
CAPA Close |
Detail |
23-0329-D |
E |
Cross Audit DVL 2023
There is no identity label (label ID SAP) attached to the packaging Material calcium carbonate (TREX-00000006), on the original packaging (material received from DVL Gunung Putri). |
m |
PA |
Check SOP supply material to dispensing, wheter already state the activities to check ID SAP Label |
MAESAROH; Maria Euphrasia |
10 Jun 2023 |
CAPA Close |
Detail |
23-0329-D |
E |
Cross Audit DVL 2023
There is no identity label (label ID SAP) attached to the packaging Material calcium carbonate (TREX-00000006), on the original packaging (material received from DVL Gunung Putri). |
m |
PA |
Check SOP Handling Packaging Material in Warehouse and Refreshment SOP Handling Packaging Material in Warehouse related to Receiving Packaging Material |
MAESAROH; Maria Euphrasia |
17 Jun 2023 |
CAPA Close |
Detail |
22-0434-D |
E |
Audit Unilab tahun 2022
Discrepancies in the batch records were noted, as follows:
a. In the batch records of Biogesic 500mg Tablet, batch no. 22181201:
i. Based on the Weighing Record and Raw Material Identification Tag for Sodium Starch Glycolate, the standard weighing balance to be used should either be T5, T6, or T7, but the actual balance used was T4;
ii. Incorrect unit of measure for the Inlet Air Temperature of Glatt FBD during Partial and Final Spray Drying was reflected (i.e., written as 76-84 m3/h instead of ºC;
iii. Batch number was not indicated on the moisture content printouts;
iv. Yield after wet compounding of granulation batch no. 01B was 103.3%, which was above the allowable limit of 98-101%. No explanation was provided for this particular deviation.
v. In the Process Bulk Delivery Slip for the granules after compounding, corresponding columns for the receipt and checking of bulk granules were not filled out
vi. Actual quantity of samples subjected to leak test during packaging was not documented in the In-process Control form.
b. Deviation was noted in the packaging records of Alaxan FR Capsule, batch no. 22192601. Actual encapsulation speed was at 700 capsules/min, which was below the BPR-prescribed speed of 1400 capsules/min.
|
M |
CA |
Revise manufacturing batch record product Biogesic related to unit measurement during process |
MARDI; IWAN NURIHWANI; SOPANDI; Befri Hadi Sidiki; Novensius Dillen; Rahmat Hastomo
|
06 Jan 2023 |
CAPA Close |
Detail |
22-0434-D |
E |
Audit Unilab tahun 2022
Discrepancies in the batch records were noted, as follows:
a. In the batch records of Biogesic 500mg Tablet, batch no. 22181201:
i. Based on the Weighing Record and Raw Material Identification Tag for Sodium Starch Glycolate, the standard weighing balance to be used should either be T5, T6, or T7, but the actual balance used was T4;
ii. Incorrect unit of measure for the Inlet Air Temperature of Glatt FBD during Partial and Final Spray Drying was reflected (i.e., written as 76-84 m3/h instead of ºC;
iii. Batch number was not indicated on the moisture content printouts;
iv. Yield after wet compounding of granulation batch no. 01B was 103.3%, which was above the allowable limit of 98-101%. No explanation was provided for this particular deviation.
v. In the Process Bulk Delivery Slip for the granules after compounding, corresponding columns for the receipt and checking of bulk granules were not filled out
vi. Actual quantity of samples subjected to leak test during packaging was not documented in the In-process Control form.
b. Deviation was noted in the packaging records of Alaxan FR Capsule, batch no. 22192601. Actual encapsulation speed was at 700 capsules/min, which was below the BPR-prescribed speed of 1400 capsules/min.
|
M |
CA |
Training manufacturing batch record after revise (Biogesic) |
MARDI; IWAN NURIHWANI; SOPANDI; Befri Hadi Sidiki; Novensius Dillen; Rahmat Hastomo
|
12 Jan 2023 |
CAPA Close |
Detail |
CAPA/GMP/21/0015 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
MARDI; IWAN NURIHWANI; SOPANDI; Befri Hadi Sidiki; Novensius Dillen; Rahmat Hastomo
|
14 Dec 2021 |
CAPA Close |
Detail |
CAPA/GMP/21/0016 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
MARDI; SETIO HARMONO; Ricko Aditya; Arga Wahyu Hidayat |
14 Dec 2021 |
CAPA Close |
Detail |
22-0434-D |
E |
Audit Unilab tahun 2022
Discrepancies in the batch records were noted, as follows:
a. In the batch records of Biogesic 500mg Tablet, batch no. 22181201:
i. Based on the Weighing Record and Raw Material Identification Tag for Sodium Starch Glycolate, the standard weighing balance to be used should either be T5, T6, or T7, but the actual balance used was T4;
ii. Incorrect unit of measure for the Inlet Air Temperature of Glatt FBD during Partial and Final Spray Drying was reflected (i.e., written as 76-84 m3/h instead of ºC;
iii. Batch number was not indicated on the moisture content printouts;
iv. Yield after wet compounding of granulation batch no. 01B was 103.3%, which was above the allowable limit of 98-101%. No explanation was provided for this particular deviation.
v. In the Process Bulk Delivery Slip for the granules after compounding, corresponding columns for the receipt and checking of bulk granules were not filled out
vi. Actual quantity of samples subjected to leak test during packaging was not documented in the In-process Control form.
b. Deviation was noted in the packaging records of Alaxan FR Capsule, batch no. 22192601. Actual encapsulation speed was at 700 capsules/min, which was below the BPR-prescribed speed of 1400 capsules/min.
|
M |
CA |
Revise manufacturing batch record product Alaxan after PQ based on recommendation PQ process |
MARDI; SETIO HARMONO; Ricko Aditya; Arga Wahyu Hidayat |
10 Mar 2023 |
CAPA Close |
Detail |
22-0434-D |
E |
Audit Unilab tahun 2022
Discrepancies in the batch records were noted, as follows:
a. In the batch records of Biogesic 500mg Tablet, batch no. 22181201:
i. Based on the Weighing Record and Raw Material Identification Tag for Sodium Starch Glycolate, the standard weighing balance to be used should either be T5, T6, or T7, but the actual balance used was T4;
ii. Incorrect unit of measure for the Inlet Air Temperature of Glatt FBD during Partial and Final Spray Drying was reflected (i.e., written as 76-84 m3/h instead of ºC;
iii. Batch number was not indicated on the moisture content printouts;
iv. Yield after wet compounding of granulation batch no. 01B was 103.3%, which was above the allowable limit of 98-101%. No explanation was provided for this particular deviation.
v. In the Process Bulk Delivery Slip for the granules after compounding, corresponding columns for the receipt and checking of bulk granules were not filled out
vi. Actual quantity of samples subjected to leak test during packaging was not documented in the In-process Control form.
b. Deviation was noted in the packaging records of Alaxan FR Capsule, batch no. 22192601. Actual encapsulation speed was at 700 capsules/min, which was below the BPR-prescribed speed of 1400 capsules/min
|
M |
PA |
Training manufacturing batch record product Alaxan FR Capsule after revise |
MARDI; SETIO HARMONO; Ricko Aditya; Arga Wahyu Hidayat |
24 Mar 2023 |
CAPA Close |
Detail |
22-0437-D |
E |
Audit Unilab tahun 2022
As specified in the Batch Manufacturing Records of Alaxan FR Capsule, batch number 22246601, prescribed tamping plunger set for encapsulation was 17, 20,19,19, 20. However, actual set used was 21, 23, 22, 24, 18. |
M |
CA |
Revise manufacturing batch record Alaxan FR Capsule to add "Tamping plunger stated in batch manufacturing records only used" |
MARDI; SETIO HARMONO; Ricko Aditya; Arga Wahyu Hidayat |
05 Jan 2023 |
CAPA Close |
Detail |
22-0437-D |
E |
Audit Unilab tahun 2022
As specified in the Batch Manufacturing Records of Alaxan FR Capsule, batch number 22246601, prescribed tamping plunger set for encapsulation was 17, 20,19,19, 20. However, actual set used was 21, 23, 22, 24, 18. |
M |
CA |
Training manufacturing batch record Alaxan FR Capsule after revise |
MARDI; SETIO HARMONO; Ricko Aditya; Arga Wahyu Hidayat |
12 Jan 2023 |
CAPA Close |
Detail |
CAPA/GMP/21/0006 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
HENNY DWI MARYANI; ANTENG JATMIKO; EKO PRIYONO; SUSI MIRASARI; M Syauqi Abdullah
|
14 Dec 2021 |
CAPA Close |
Detail |
CAPA/GMP/21/0014 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
HENNY DWI MARYANI; TRY IGA SEPTIAWANDARI; SUSI MIRASARI
|
14 Dec 2021 |
CAPA Close |
Detail |
22-0431-D |
E |
Audit Unilab tahun 2022
The temperature in the secondary packaging area was maintained at 20-28ºC. However, as claimed, certain products with storage condition of NMT 25ºC were also being packed in the same area. |
m |
CA |
Initiate change control related to accommodate change of temperature specification |
HENNY DWI MARYANI; TRY IGA SEPTIAWANDARI; SUSI MIRASARI
|
29 Feb 2024 |
CAPA Close |
Detail |
CAPA/GMP/21/0010 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
Suci Rahmawati; Erlinda; Rachma Yuliana |
14 Dec 2021 |
CAPA Close |
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 |
Put PQ of equipment or validation system as requirement on URS |
Suci Rahmawati; Erlinda; Rachma Yuliana |
31 Mar 2023 |
CAPA Close |
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 |
Placement data logger based on mapping result |
Suci Rahmawati; Erlinda; Rachma Yuliana |
15 Jul 2023 |
CAPA Close |
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 |
Install portable dehumidifier or AC to achieve target temperature & RH based on recommendation from technician |
Suci Rahmawati; Erlinda; Rachma Yuliana |
30 Jun 2023 |
CAPA Close |
Detail |
CAPA/GMP/21/0004 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2024
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
SHAFA NABILAH; Kevin Dio Naldo
|
14 Dec 2021 |
CAPA Close |
Detail |
24-0164-D |
E |
CAPA Vendor Audit Hensan Bersama Sukses |
m |
CA |
CAPA Vendor Audit Hensan Bersama Sukses - Refer to audit report |
Kiki Zakiah |
07 Jun 2024 |
CAPA Close |
Detail |
24-0163-D |
E |
CAPA Vendor Audit Menjangan Sakti |
m |
CA |
CAPA Vendor Audit Menjangan Sakti - Refer to audit report |
Kiki Zakiah |
07 Jun 2024 |
CAPA Close |
Detail |
24-0161-D |
E |
CAPA Vendor Audit Tatarasa |
m |
CA |
CAPA Vendor Audit Tatarasa - Refer to audit report |
Kiki Zakiah |
07 Jun 2024 |
CAPA Close |
Detail |
CAPA/GMP/21/0007 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
QA VALIDATION |
14 Dec 2021 |
CAPA Close |
Detail |
22-0436-D |
E |
Audit Unilab tahun 2022
Deficiencies relating to bulk hold time were noted, as follows:
Risk assessment or justification for the selection of representative products to be subjected to hold time studies was not available.
|
m |
CA |
Copy of the risk assessment for the selection of representative products for the concluded bulk hold time study |
QA VALIDATION |
31 Dec 2023 |
CAPA Close |
Detail |
CAPA/GMP/21/0009 |
E |
Finding sesuai Berita Acara Pemeriksaan BPOM Audit 24-26 Nov 2021
|
M |
CA |
Mengirimkan Root Cause dan CAPA temuan BPOM Audit 24-26 Nov 2021 ke QA Compliance
|
ERA MARISHA |
14 Dec 2021 |
CAPA Close |
Detail |