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Procedure for GMP compatibility Surveys application

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Procedure for GMP compatibility Surveys application

About GMP compatibility Surveys application

 GMP compatibility Surveys is pharmaceutical products (except pharmaceutical products for diagnosis out of the body) or Surveys to confirm whether method of manufacturing management in factory of unregulated drug (we say pharmaceutical products as follows.) and quality control adapts to standard to set with Ministry of Health, Labour and Welfare ordinance No. 179 (December 24, 2004).

 When it is necessary or when it is going to produce pharmaceutical products for export when we are going to receive production and sales approval such as pharmaceutical products when we receive approval of partial change of approved matter, we will investigate the item for each factory. In addition, it is necessary to receive Surveys every five years to continue approval after the approval acquisition.

 

Submission documents

(A) New Surveys

Compatibility Surveys with the export of production and sales application for approval, complete change application for approval and pharmaceutical products Notifecations for export
(1) Pharmaceutical products compatibility Surveys application
(2) Application attachment
At the time of GMP compatibility Surveys application, please attach documents of (i) as follows (a).
(a) Copying (include Surveys which other Surveys incarnation carried out.) of compatibility findings notification pertaining to GMP Surveys carried out in the past 2 years from day of application of compatibility Surveys or findings report
(i) Copy of production and sales written application for approval (when is based on report of export such as replacement wish, export pharmaceutical products when meet when submit request for replacement the notification form copy)
(3) Prior submission material
(1) Separately from ,(2), please submit prior submission material within two weeks before Surveys day. In addition, you may have you submit prior submission material with (1), (2).

 

(B) Periodical Surveys

Compatibility Surveys to carry out after the report of export of pharmaceutical products for together with five years and export after the production and sales approval every five years
(1) Pharmaceutical products compatibility Surveys application
(2) Application attachment
At the time of GMP compatibility Surveys application, please attach documents of ... (ki) as follows (a).
(a) Copying (include Surveys which other Surveys incarnation carried out.) of compatibility findings notification pertaining to GMP Surveys carried out in the past 2 years from day of application of compatibility Surveys or findings report
(i) Copying (when is based on report of export of pharmaceutical products for export copying of the notification form) of production and sales written acknowledgment
(u) Copying of complete change written acknowledgment for the past 5 years
(e) Copying of immaterial alteration notice for the past 5 years
(o) Information which classified by work place, workroom, area, facilities if performed application pertaining to items two or more at the same time, and chose representative product every classification, and showed grounds of the classification and the choice reason
(xiv) Having collection or not pertaining to application item for the past 5 years (summary in the case of existence)
(ki) Written oath (by style of attached sheet 1-3-1 of March 30, 2005 nichifuyakushokukammahatsudai 0330001)
※When we appoint representative item (a) and information about (i) may limit to thing pertaining to the representative item concerned.
(3) Prior submission material
(1) Separately from ,(2), please submit prior submission information about periodical Surveys We open with the other window(PDF: 128.3 kilobytes) within two weeks beforePDF Surveys day. You may have you submit prior submission material with (1), (2).
 

Material submission time

(1) Application and application attachment

  (a) Submit within one month before new Surveys permission time limit
  (i) Submit within three months before periodical Surveys permission time limit
(2) Prior submission material
   We submit within two weeks before scheduled Surveys date
 

Fee

Please pay application fee in conjunction with application without putting with Saga income certificate stamp.

Please refer to GMP compatibility Surveys fee We open with the other window(PDF: 58.9 kilobytes) forPDF concrete fee.
In addition, we sell Saga income certificate stamp We open with the other windowin the next Saga certificate stamp selling judgment place. (there is sale place supporting mail sale)
 

Submission

〒840-8570

1-1-59, Jonai, Saga-shi, Saga
Saga Department of Health and Welfare Pharmaceutical Division medicine manufacture, hot spring charge
 

Various styles

(A) New Surveys

  Word Style 1 factory summary We open with the other window(word: 68.5 kilobytes)

  Word Style 2 subjects of survey item summary We open with the other window(word: 65.5 kilobytes)


(B) Periodical Surveys
  Excel Manufactured item table We open with the other window(Excel: 12.7 kilobytes)
  Word Written oath We open with the other window(word: 29.5 kilobytes)

 

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Saga prefectural government office (corporation number 1000020410004) 〒 840-8570  1-1-59, Jonai, Saga-shi   Tel: 0952-24-2111 (main)     
Copyright© 2016 Saga Prefecture.All Rights Reserved.

Saga prefectural government office (corporation number 1000020410004)

〒840-8570
1-1-59, Jonai, Saga-shi
Tel: 0952-24-2111 (main)
Copyright© 2016 Saga Prefecture.All Rights Reserved.