JKS Document Store
 Store FrontAccountSearchProduct ListBasket Contents Checkout 
Search For The Following Word(s):
Sign In

Medicinal Products Lifecycle
  1. Discovery
  2. Preclinical
  3. Clinical
  4. Dossier
  5. Authorities
  6. Approval
  7. Manufacturing
    Quality regulations
  8. Export & Import
  9. Pricing & Reimburcement
  10. Marketing
  11. Postmarketing
  12. Reevaluation & Reexamination
Medical Devices
Japan Monitor (ISSN 1550-3429)
Information Meetings
Legislation and Agreements
All in Japan (ISSN 1550-3402)
E-health Japan (ISSN 1550-3410)
EU Pharma & Medical Devices
Free documents

Standards for Manufacturing Control and QA for Drugs and Quasi-drugs (Enterprise License)

Standards for Manufacturing Control and QA for Drugs and Quasi-drugs (Enterprise License)Quantity in Basket:none
Code: 7_D_B008

29-page Medicinal Products Lifecycle document. S Enterprise-wide Use License. Full text in English of the MHLW Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs, MHLW Ordinance No. 179, December 24, 2004 (also known as the “Good Manufacturing Practice Ordinance" or shortly as the “GMP Ordinance". Formatted, indexed, annotated and hyperlinked. Jouhou Koukai Publishing is a Jouhou Koukai business: pharmaceuticals, medical devices, drug approval, regulations, clinical trials, Japan pharmaceutical affairs, and global and Japanese regulatory affairs. Retrieval and consulting on drug approval and technical documents disclosed in Japan. (ISSN 1550-3437) Copyright © JKS LLC 2006.

Related Item(s)
Code Name Price    
7_D_B004 Standards for QA for Drugs, Quasi-drugs, Cosmetics and Medical Devices (Enterprise-wide Use License) $1,450.00
7_D_B002 Enforcement Regulations of PAL: Regulations for Buildings and Facilities (Enterprise License) $1,950.00
7_D_B006 Standards for MC and QA for Medical Devices / In-vitro Diagnostics (Enterprise License) $2,950.00