Quality Policy

The Katayama Quality Policy and Quality Action Guidelines.

Quality Policy

Katayama Seiyakusyo creates a Quality Culture and promises to pursue safe and reliable medicine creation with a sense of pride that all of our activities ultimately bring smiles to patients’ faces.

Quality Action Guidelines

Katayama Seiyakusyo has established Quality Action Guidelines for fulfilling our Quality Policy.
一 Comply with all regulations and contracts
一 Follow and continuously improve an effective Pharmaceutical Quality System
一 Ensure data integrity
一 Conduct quality risk management
一 Apply corrective action and preventive action (CAPA)
一 Provide continual education and training for all employees

Production Equipment

Through cooperation between our Research Department and Manufacturing Department, we are able to support multi-step production for orders ranging from several kilograms to several tons. With our multi-purpose equipment, we manufacture a wide range of high-quality APIs and intermediates through cGMP-compliant production and quality control.

With the cooperation of the Research Department, we support sample work, pilot production, and high-mix, small-volume production to medium-scale production of commercial products.

Equipement Material Size Unit
Reactor GL 1,400~2,000 L 10
600~1,000 L 4
50~300 L 5
SUS 500 L~1,200 L 12
80 L 1
Autoclave reactor SUS 600 L (0.97 MPa) 1
Low-temperature reaction reactor SUS 1,000 L (-100℃~) 1
High-temperature reaction reactor SUS 700 L (~300℃) 1
Drying equipment Tray dryer SUS 300~500 L 7
Vacuum tray dryer SUS 200 L 1
Conical dryer GL 300~800 L 3
Centrifuge Top discharge type SUS 24 inch 10
Aflon lining 24 inch 3
Hastelloy and ETFE 15 inch 1
Filtration equipment GL 50~100 L 2
SUS 50~110 L 4
SUS Columns 2
Pulverizing equipment Soft mill SUS 2
COMIL SUS 1
Pin mill SUS 1
Clean room (Class 100,000)
Centrifuge Top discharge type SUS 24 inch 1
Drying equipment Tray dryer SUS 500 L 1
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Reaction equipment
Reaction equipment
Low-temperature reaction equipment (-80°C)
Low-temperature reaction equipment (-80°C)
Drying room
Drying room

We support large-volume production of pharmaceutical intermediates and active pharmaceutical ingredients including after midterm investigating and commercial products.

Equipement Material Size Unit
Reactor GL 8,000 L 1
2,000~5,000 L 25
100~500 L 3
SUS 1,500~5,000 L 13
300 L~1,000 L 4
Autoclave reactor GL 3,000 L (0.97 MPa) 2
800 L (0.97 MPa) 1
Low-temperature reaction reactor SUS 4,400 L(-100℃~) 1
Drying equipment Air tray dryer SUS 1,000 L 3
Conical dryer GL 1,500 L 2
SUS 1,500 L 1
Centrifuge Top discharge type SUS 30~42 inch 8
Aflon 30 inch 3
Bottom discharge type SUS 24~36 inch 9
Filtration equipment GL 0.13~0.5 m² 5
SUS 0.13~1.26 m² 10
Pulverizing equipment Soft mill SUS 2
COMIL SUS 2
Fine impact mill SUS 1
Pin mill SUS 1
Clean room (CLASS 100,000)
Reactor GL 4,000 L 1
Centrifuge Top discharge type SUS 30 inch 1
Drying equipment Conical dryer GL 800 L、1,500 L 1
Other
Pulverizing equipment, Sieving equipment, Centrifugal thin film vacuum evaporater, Ultrafiltration unit, Electrolyzer system
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Reaction equipment
Reaction equipment
Conical dryer
Conical dryer
Clean room
Clean room

The 3rd building Equipment

We constructed a new building to improve production capacity in 2016. It complies with the current GMP and computer controlled systems are installed.

Equipement Material Size Unit
Reactor GL 10,000 L 1
8,000 L 1
5,000~6,000 L 5
3,000 L 1
SUS 800、2,000 L 2
Autoclave reactor GL 3,000 L (0.97 MPa) 2
Drying equipment Conical dryer GL 1,500 L、2,000 L 2
Centrifuge Top discharge type SUS 42 inch 1
HASTELLOY 42 inch 1
Bottom discharge type SUS 48 inch 1
Filtration equipment GL 0.12 m² 1
SUS 0.5 m² 1
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10,000 L GL Reactor
10,000 L GL Reactor
HASTELLOY Centrifuge
HASTELLOY Centrifuge
Building appearance
Building appearance
Physical Methods

Chromatography

  • High-performance liquid chromatograph (HPLC)
  • Charged Aerosol Detector (CAD)
  • Gas chromatograph(GC)
  • Headspace sampling system

Spectroscopic Methods

  • Nuclear magnetic resonance spectrometer (FT-NMR)
  • Atomic absorption spectrophotometer
  • Inductively coupled plasma atomic emission spectrometry
  • Ultraviolet and visible spectrophotometers (UV/VIS)
  • Infrared spectrophotometer (FT-IR)

Other Physical Methods

  • Refractometer
  • Karl Fischer moisture titrator
  • Polarimeter
  • Potentiometric titrator
  • Conductivity meter
  • Differential thermal analysis and thermogravimetry equipment (DTA, TG)
  • Powder X-ray diffractometer
  • Total organic carbon analyzer (TOC)
  • Melting point apparatus
Powder property Determinations
  • Tap density determinator
  • Polarizing microscope, optical microscope,
  • Stereoscopic microscope
  • Laser diffraction particle size analyzer
Microbial Tests
  • Toxinometer
  • Microbial testing apparatus
    (Clean bench, safety cabinet, autoclave, dry heat sterilizer, incubator)
Other
  • Stability testing chamber
Gas chromatograph (GC)
Gas chromatograph (GC)
High-performance liquid chromatograph (HPLC)
High-performance liquid chromatograph (HPLC)
Nuclear magnetic resonance spectrometer(FT-NMR)
Nuclear magnetic resonance spectrometer(FT-NMR)

Research System

Our Research Department located in the Hirakata Plant plays a central role in our contract development and manufacturing operations. The department applies our extensive knowledge of organic synthesis and scale-up technologies to meet client needs at all stages of APIs and intermediates manufacturing.

Initial Development Stage

  • Synthetic route development for a compound
  • Testing method development
  • Lab sample synthesis

Intermediate Development Stage

  • Establish API and intermediate manufacturing methods
  • Synthetic route and cost efficiency improvement
  • Process safety examination
  • Scale-up

Final Development Stage

  • Application data collection
  • QRA
  • Process validation
  • DMF registration
flowchart

The Research Department is fully equipped with various devices and equipment needed to test industrialization and manufacturing methods. Our system meets client delivery schedules and product quality specifications and is capable of addressing any issues that arise.

Main experimental devices and equipment

NMR、LC-MS、HPLC、UPLC、GC、SC-DSC、TG-DTA、XRPD、Easy Max 402 HFcal(Reaction calorimeter)、Particle Track(Real-time particle distribution measuring device)、Easy Viewer(Particle image analyzer)

SC-DSC
SC-DSC
XRPD
XRPD
Easy Max 402 HFcal
Easy Max 402 HFcal

GMP Compliance System

Our GMP system, constructed for strict compliance with domestic and overseas GMP and ICH GMP guidelines for APIs, has received approval from the PMDA in Japan, the FDA in the U.S., and regulatory authorities in Europe, and is rated highly by clients as well.
We have also created and engage a Pharmaceutical Quality System to improve the quality of pharmaceutical products and ensure stable supply. The Quality Assurance Department and Quality Control Department engage in all quality-related requirements independently of the Manufacturing Division, and are fully authorized to execute GMP management.
Manufacturing management follows a strict GMP system in all processes from raw material procurement to product shipment.
Our comprehensive system enables us to fully meet the quality standards of our clients.

Quality assurance (QA)

We carry out work related to quality assurance in strict compliance with the latest laws, regulations, rules, and guidelines from government institutions and related organizations.

Quality control (QC)

By collecting the latest information on official compendia and analytical technology, and by reflecting these in our testing and inspection, we enrich our quality management work.

Manufacturing management

From selection of raw materials to procurement and on to shipment of manufactured product, we support clients' desired delivery dates with a flexible schedule under strict GMP management.

GMP organization chart

We have constructed the following proprietary GMP organization at our Hirakata Plant and Toyama Plant.

GMP organization chart

Documentation system of GMP

GMP文書体型図

From arrival of raw materials to shipment of product

From arrival of raw materials to shipment of product

Audits and Inspections

Manufacturing APIs and intermediates requires inspections by regulatory authorities or audits by clients. Both of our plants have been evaluated highly in inspections by regulatory authorities and in audits by clients.

Organization Period Details
FDA 2008 GMP inspection
2014 GMP inspection
2017 GMP inspection
2022 GMP inspection
PMDA 2018 GMP inspection
Prefectural Government 1998 Acquisition of pharmaceutical manufacturer license
2003 Renewal of pharmaceutical manufacturer license
2008 Renewal of pharmaceutical manufacturer license
2013 Renewal of pharmaceutical manufacturer license
2018 Renewal of pharmaceutical manufacturer license
2023 Renewal of pharmaceutical manufacturer license
Clients authorities 1997- Over 50 audits and over 100 inspections
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PMDA : Pharmaceuticals and Medical Devices Agency
FDA : U.S. Food and Drug Administration

Organization Period Details
FDA 2004 GMP inspection
2016 GMP inspection
2019 GMP inspection
EMA/AIFA 2007 GMP inspection
PMDA 2011 GMP inspection
2012 GMP inspection
2013 GMP inspection
2015 GMP inspection
2021 GMP inspection
Prefectural Government 1988 Acquisition of pharmaceutical manufacturer license
1993 Renewal of pharmaceutical manufacturer license
1998 Renewal of pharmaceutical manufacturer license
2002 Renewal of pharmaceutical manufacturer license
2004 GMP compliance inspection for export pharmaceuticals
2007 Renewal of pharmaceutical manufacturer license
2008 GMP inspection
2010 GMP inspection
2012 Renewal of pharmaceutical manufacturer license
Acquisition of veterinary drug manufacturer license
2014 GMP inspection
2017 Renewal of pharmaceutical manufacturer license
Renewal of veterinary drug manufacturer license
2018 GMP inspection
2022 Renewal of pharmaceutical manufacturer license
Renewal of veterinary drug manufacturer license
Clients authorities 1988- Over 50 audits and over 300 inspections
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PMDA : Pharmaceuticals and Medical Devices Agency
FDA : U.S. Food and Drug Administration
EMA : European Medicines Agency
AIFA : Agenzia Italiana del Farmaco