PROCEDURE FOR ISSUANCE OF GDP CERTIFICATION

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04Jul

PROCEDURE FOR ISSUANCE OF GDP CERTIFICATION

  1. APPLICATION OF PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR PHARMACEUTICAL PRODUCTS AND PHARMACEUTICAL STARTING MATERIALS
No. Regulated entities Applied standards
1 Pharmaceutical product distributors WHO guideline of GDP for pharmaceutical products
2 Pharmaceutical raw material distributors WHO guideline of GDP for pharmaceutical raw materials

 

  1. INPSECTION OF COMPLIANCE WITH GDP INITIALLY

2.1 Dossier 

  1. Documents used as basis for inspection of compliance with GDP principles by a pharmacy business establishment are application for certificate of eligibility for pharmacy business (the distributor is not required to submit these documents because they have been submitted when it applies for the certificate of eligibility for pharmacy business)

The technical documents about distributors shall be prepared in accordance with guidelines for the site master file provided in the applicant form No. 05 Appendix IV.

  1. The distributor that wishes to apply for issuance of the certificate of GDP compliance together with the certificate of eligibility for pharmacy business, it must mentioned in the application form for issuance of the certificate of eligibility for pharmacy business.

2.2 Procedures for inspection of compliance with principles of GDP initially

  1. Receive the dossier

The distributor shall submit 01 dossier and pay assessment fees.

  1. Procedures for receiving and inspecting a dossier are specified in.

2.4 Processing the inspection results of compliance with  GDP

  1. The distributor complied at level 1:

Within 10 days from the end of inspection at the distributor facility and the date of signing the inspection report, the Department of Health shall issue the certificate of eligibility for pharmacy business or issue the certificate of GDP compliance according to the Form No. 06 in the Appendix IV 03/2018/TT-BYT.

Within 20 days in the case of a distributor has business of controlled pharmaceutical products.

  1. The distributor complied at level 2:
  2. a) Within 05 days from the end of inspection at the distributor facility and the date of signing the inspection record, a dispatch will be sent to the distributor by the Department of Health to require the distributor perform the corrective actions according to the inspection report.

Within 15 days In the case of a distributor has business of controlled pharmaceutical products.

  1. b) After corrective actions are taken, the distributor shall send a notification and evidences (documents, images, videos or certificates) proving that the deficiencies specified in the inspection record are corrected;
  2. c) Within 20 days from the date on which the notification of corrective actions taken is received, the Department of Health shall assess the correction result and conclude GDP compliance status of the distributor.

– The results of corrective actions meet the requirements: the Department of Health shall issue the certificate of eligibility for pharmacy business or the certificate of GDP compliance according to Form No. 06 in the Appendix IV Circulation 03/2018/TT-BYT;

– The results of corrective actions do not meet the requirements: the Department of Health shall provide explanation for rejecting the dossier in writing.

  1. d) The document is no longer valid:

– Within 06 months from the date on which additional documents are requested in writing by the Department of Health, if the distributor has not performed corrective action such request

– Or the documents is not satisfactory within 12 months from the submission initially,

  1. The distributor complied at level 3:

Within 05 days from the end of the inspection at the distributor facility and the date of signing the inspection record, the Department of Health shall send notify the distributor in writing of its failure to comply with with GDP principles and refusal to issue the certificate.

  1. Within 05 days from the date of issuing the certificate of eligibility for pharmacy business or the certificate of GDP compliance, the Department of Health shall publish the following information on the website of the Department of Health:
  2. a) Name and address of the distributor;
  3. b) Full name of the pharmacist, pharmacy practice certificate number;
  4. c) Number of the certificate of eligibility for pharmacy business and certificate of GDP compliance (if any);
  5. d) Expiry date of the inspection of compliance with GDP principles;
  6. e) Distributor’s scope of operation.

III. INPSECTION OF MAINTENANCE OF COMPLIANCE WITH GDP

3.1 Periodic inspections of maintenance of compliance with GDP

  1. A periodic inspection of maintenance of compliance with GDP principles at a distributor shall be carried out every 03 years from the end of the previous inspection.
  1. In November every year, the Department of Health shall publish the plan for periodic inspections of maintenance of compliance of the distributor with GDP principles in the succeeding year on its website.
  1. The distributor must submit a dossier for the periodic inspection to the Department of Health at least 30 days before the date of carrying out the inspection according to the published plan.
  1. In case the distributor does not submit the dossier for the periodic inspection by the deadline, within 10 days from the deadline for submission of the dossier, the Department of Health shall request the distributor in writing to provide explanation for failure to submit the dossier for the periodic inspection.
  1. Within 30 days from the date on which the Department of Health requests the distributor in writing to provide explanation for failure to submit the dossier for the periodic inspection, if the distributor does not submit the dossier as prescribed, the Department of Health shall revoke the distributor’s certificate of eligibility for pharmacy business.
  1. After submitting the dossier within the timeline, the distributor shall continue its distribution activities within the scope specified in the certificate of eligibility for pharmacy business from the date on which the application is submitted to the date on which the periodic inspection results are obtained.
  1. An dossier for the periodic inspection of maintenance of compliance with GDP principles includes:
  2. a) An application form (Form No. 01 in the Appendix IV circulation 03/2018/TT-BYT;
  3. b) Updated technical documents about infrastructure, technology and personnel of the distributor (in case of change);
  4. c) A brief report on the distribution of pharmaceutical products and pharmaceutical starting materials over the last 03 years from the date of the previous inspection to the date on which the periodic inspection is requested.

3.2 Processing results of periodic inspection of compliance with GDP

  1. The distributor complied at level 1:

Within 10 days, the Department of Health shall issue the certificate of GDP compliance according to Form No. 06 in the Appendix IV, circulation 03/2018/TT-BYT.

  1. The distributor complied at level 2:
  2. a) Within 05 days, the Department of Health shall request the distributor in writing to correct the observations;
  3. b) Within 45 days from the date on which the Department of Health requests in writing, the distributor shall take corrective actions and send a notification enclosed with evidences (documents, images, videos or certificates) proving that the deficiencies specified in the inspection report are corrected;
  4. c) Within 20 days from the date on which the notification of corrective actions taken and evidences are received, the Department of Health shall assess the correction result and conclude GDP compliance status of the distributor as follows:

– The results of corrective actions meet the requirements: The Department of Health shall issue the certificate of GDP compliance;

– The results of corrective actions do not meet the requirements: The Department of Health shall request the distributor in writing to keep taking corrective actions and send an additional notification. The time limit for keeping taking corrective actions and sending the additional notification is 45 days from the date of receiving the request.

  1. d) Within 90 days from the end of inspection at facility, if the distributor does not send a notification of corrective actions taken or the corrective actions have not complied with GDP principles after they are taken, the Department of Health shall send a notification of non-compliance with GDP principles. It depends on the level of violation that will be treated according to part 3 as bellow.
  1. The distributor complied at level 3:

Within 05 days, the Department of Health shall take one or several following actions:

  1. a) Impose penalties against administrative violations;
  2. b) Revoke the certificate of eligibility for pharmacy business and the certificate of GDP compliance (if any).

To downsize scope of business in certificate of eligibility for pharmacy business about the operations do not meet requirements.

  1. Within 05 days, the Department of Health shall publish on website:

– The GDP compliance status.

– Information related to the revocation of the issued certificate of eligibility for pharmacy or the issued certificate of GDP compliance (if any).

3.3 Change control

Change Distributor The Department of Health
a) Any establishment that already has a Certificate of eligibility for pharmacy business but then changes its scope of business and thus changes the applicable conditions; or changes the business location. Submit an dossier for issuance of the certificate of eligibility for pharmacy business Follow the inspection of compliance with principles of GDP initially
b) Change of the location of the warehouse  at the same business location Submit a notification of change enclosed with technical documents corresponding to the change to the Department of Health. Perform an inspection at distributor facility

Follow the periodic inspections of maintenance of compliance with GDP
c) Addition of a warehouse at a new location at the same business location
d) Expansion of the existing warehouse; Submit a notification of change enclosed with technical documents corresponding to the change to the Department of Health Within 10 days, send a written consent or requirement of the corrective actions.

The distributor performed corrective action and report:

– The results meet requirements: send a written consent within 10 days

– The results do not meet requirements: will carry out an unscheduled inspection within 12 months.
e) Change in the structure and layout of the warehouse
f) Change of the utility system or change of principles of design, operation of the utility system which affects the storage conditions

 

3.4 Unscheduled inspections and audits of maintenance of compliance with principles of GDP

The Department of Health shall carry out an unscheduled inspection of maintenance of GDP principles at a distributor in one of the following cases:

  1. a) The results of corrective actions do not meet requirements;
  2. b) The distributor complied at level 2 that will be audited at least 01 unscheduled inspection within 3 years from the end of the previous inspection;

c) There are reflections, propositions or  critical violation of GDP principles  according to inspection report of authority.