Quality Audit Reports
Quality Audit Reports by Consortium or Third Party Providers
Planova virus removal filters are manufactured at multiple sites in Japan. Customers requiring quality audit reports for submission to regulatory agencies can save time and cost by purchasing report packages covering one or multiple products from the International Pharmaceutical Supply Chain Consortium or other third party vendors.
- Purchased quality audit reports are accepted by the FDA and EMA.
- Consortium membership is not required to make a purchase.
- Customers can save time, cost and environmental impact.
Providers and Available Quality Audit Reports
Refer to the tables below to identify reports covering specific manufacturing sites and products.
| Provider | Report No. | Site | Audit date | Audit method | Link to Website | Contact |
|---|---|---|---|---|---|---|
| Rx-360 | JA3107 | Planova Plant (Nobeoka) Planova Okatomi Plant (Nobeoka) |
Feb 18-20, 2026 | Onsite | Audit Report Inventory | Chelsea Carlos |
| JA3108 | Planova Oita Plant (Oita) | Feb 16-17, 2026 | Onsite | |||
| Qualifyze | - | Planova Plant (Nobeoka) | Mar 13-14, 2024 | Onsite | Submit Form | Marjolaine Pinot |
| - | Planova Oita Plant (Oita) | Mar 15, 2024 | Onsite | Submit Form | ||
| Rephine | AUD-3636 | Planova Plant (Nobeoka) | May 19, 2025 | Onsite | Audit Report Inventory | Yalan Yang or Rephine Enquiries |
| AUD-3636 | Planova Oita Plant (Oita) | May 20, 2025 | Onsite |
Use of Planova Quality Audit Reports from Consortium or Third-Party Audit Providers
Since 2016, a total of 39 companies have purchased quality audit reports.
We have a track record of major pharmaceutical companies in the United States, Europe and Asia purchasing Planova quality audit reports.
We have a track record of major pharmaceutical companies in the United States, Europe and Asia purchasing Planova quality audit reports.
Applicable Products and Manufacturing Sites
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Planova Plant
6-4158 Asahimachi Nobeoka-shi, Miyazaki 882-0847, Japan
Nobeoka Product List
Table 1. Planova™ Virus Removal Filters products| Filter type | Effective surface area (m²) | Catalog number |
|---|---|---|
| Planova 15N | 4.0 | 15N4-000 |
| 1.0 | 15F1-000 | |
| 0.3 | 15NZ-300 | |
| 0.12 | 15NZ-120 | |
| 0.01 | 15NZ-010 | |
| 0.001 | 15NZ-001 | |
| Planova 20N | 4.0 | 20N4-000 |
| 1.0 | 20F1-000 | |
| 0.3 | 20NZ-300 | |
| 0.12 | 20NZ-120 | |
| 0.01 | 20NZ-010 | |
| 0.001 | 20NZ-001 | |
| Planova 35N | 4.0 | 35N4-000 |
| 1.0 | 35F1-000 | |
| 0.3 | 35NZ-300 | |
| 0.12 | 35NZ-120 | |
| 0.01 | 35NZ-010 | |
| 0.001 | 35NZ-001 | |
| Planova 75N | 1.0 | 75F1-000 |
| 0.3 | 75NZ-300 | |
| 0.01 | 75NZ-010 | |
| 0.001 | 75NZ-001 | |
| Planova S20N | 1.0 | S20-LF10 |
| 0.3 | S20-3000 | |
| 0.1 | S20-1000 | |
| 0.01 | S20-0100 | |
| 0.001 | S20-0010 |
Table 2. Planova™ BioEX Virus Removal Filters products
| Filter type | Effective surface area (m²) | Catalog number |
|---|---|---|
| Planova BioEX | 0.01 | EXZ-0100 |
| 0.001 | EXZ-0010 | |
| 0.0003 | EXZ-0003 |
Table 3. Asahi Integrity Test Solution Kit products
| Filter type | Volume (L) | Catalog number |
|---|---|---|
| AGP-HA15 | 0.88 | AGP-HA15M |
| 0.11 | AGP-HA15S | |
| AGP-HA20 | 0.88 | AGP-HA20M |
| 0.11 | AGP-HA20S | |
| AGP-HA35 | 0.88 | AGP-HA35M |
| 0.11 | AGP-HA35S |
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Planova Okatomi Plant
5-4960 Nakagawaramachi, Nobeoka-shi, Miyazaki 882-0031, Japan
Table 4. Planova™ Virus Removal Filters products
| Filter type | Effective surface area (m²) | Catalog number |
|---|---|---|
| Planova 20N | 4.0 | 20N4-000 |
| 1.0 | 20F1-000 | |
| 0.3 | 20NZ-300 | |
| 0.12 | 20NZ-120 |
-
Planova Oita Plant
2111-2 Sato, Oita-shi, Oita 870-0396, Japan
Oita Product List
Table 5. Planova™ Virus Removal Filters products| Filter type | Effective surface area (m²) | Catalog number |
|---|---|---|
| Planova 15N | 4.0 | 15N4-000 |
| 1.0 | 15F1-000 | |
| 0.3 | 15NZ-300 | |
| 0.12 | 15NZ-120 | |
| Planova 20N | 4.0 | 20N4-000 |
| 1.0 | 20F1-000 | |
| 0.3 | 20NZ-300 | |
| 0.12 | 20NZ-120 | |
| Planova 35N | 4.0 | 35N4-000 |
| 1.0 | 35F1-000 | |
| 0.3 | 35NZ-300 | |
| 0.12 | 35NZ-120 |
Table 6. Planova™ BioEX Virus Removal Filters products
| Filter type | Effective surface area (m²) | Catalog number |
|---|---|---|
| Planova BioEX | 4.0 | EX4-0000 |
| 1.0 | EX1-0000 | |
| 0.1 | EXZ-1000 |
For products not listed, please contact us for further information.
