Guideline For The Submission Of Product Samples For Laboratory Testing

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14.1     NATURAL PRODUCTS

  • a) In accordance with Directive No. 8, 2020, BPFK/PPP/07/25 (8) Jld.4. Direktif Penerimaan Keputusan Pengujian Pra-Pendaftaran Produk Semulajadi dari Makmal Swasta yang Telah Diiktiraf oleh Bahagian Regulatori Farmasi Negara (NPRA) dan Makmal Kawalan Kualiti Pengilang Tempatan, starting from 1 December 2020, the applicant is no longer required to submit samples of natural product for laboratory testing to NPRA.
  • b) The PRH shall submit a Certificate of Analysis (CoA) for the purpose of product registration evaluation.
  • c) For further details regarding submission of the CoA, refer to Appendix 7: Guideline on Registration of Natural Products, 2.7.7 Certificate of Analysis (Finished Product). 2.7.7 Certificate of Analysis (Finished Product).

 

14.2     PHARMACEUTICAL PRODUCTS (Upon NPRA request)

a) Sample shall be submitted with a cover letter containing the following information:

(i) Name and reference number of the product;

(ii) Name and address of PRH;

(iii)Name, email address and contact number of authorized person

b) Samples submitted must be in their original packaging and labelling.

c) Samples submitted must be from the same manufacturing premise as stated in the application for registration.

d) Samples submitted must have an expiry date of least one (1) year from the date of submission and must be from the same batch.

e) An official CoA and the recent shelf-life specification from the manufacturer for the same batch of sample must be submitted with the sample. Drug Registration Guidance Document (DRGD) Third Edition, First Revision July 2021 Bahagian Regulatori Farmasi Negara (NPRA) Page 48 of 62

f) The quantity of samples submitted must match the quantity requested.

g) Other materials such as HPLC columns, reagents, etc. must be submitted when requested.

h) Reference standards are required to be submitted along with the pharmaceutical products. Requirements for these reference standards are as follows:

(i) The type and quantity of reference standards submitted must match the type and quantity requested;

(ii) Reference standards submitted must have an expiry date of least one (1) year from the date of submission. In special situations, an expiry date of not less than six (6) months may be accepted;

(iii)All reference standards must be submitted with an official CoA for the same batch with the stated purity (as is, dried, anhydrous etc.) and all other relevant information (water content, loss on drying etc.);

(iv)All reference standards must be properly labelled with the name, batch number, purity and expiry date;

(v) All reference standards must be submitted in small, sealed air-tight amber glass containers.

i) The Centre of Compliance & Quality Control (PKKK) shall issue import permit for pharmaceutical products. The applicant shall ensure that the import permit is endorsed by the enforcement officer at the entry point.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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  • Last Modified: Khamis 02 Disember 2021, 15:18:11.
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