Guideline For The Submission Of Product Samples For Laboratory Testing

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The submission of sample for laboratory testing is as part of the registration process. This guideline consists of the general and specific requirements for the submission of samples to the Centre for Quality Control for laboratory testing. The general requirements define the condition of the samples to be submitted whereas the specific requirements illustrate the additional details needed according to the category of product.

The applicant is given a period of 14 working days from the date of screening approval to send samples for laboratory testing. If the samples are not submitted within the specified time frame, the application will be rejected.

The applicants shall comply with these requirements and failure to meet any of these requirements may cause rejection of the samples. 

 

11.1 GENERAL REQUIREMENTS

  • After the screening has been approved, applicants must make appointment with the Laboratory Services Unit for the submission of registration samples for laboratory testing.
  • Requirements for samples:
    1. A cover letter consisting of the following information should enclosed with every sample submission :
      • Name and reference no of product;
      • Name and address of holder;
      • Name, email address and contact number of authorized person; 
    2. Samples submitted must be in their original packaging & labeling.
    3. Samples submitted must be from the same manufacturing premise as stated in the application for registration.
    4. Samples submitted must have an expiry date of least one (1) year from the date of submission and must be from the same batch number
  •  For imported products, applicants are required to submit the original import permit together with the samples for laboratory testing.The import permit will be issued by the Centre for Registration for natural product and Centre for Quality Control for pharmaceutical products. The applicant should ensure that the import permit is endorsed by the enforcement officer at the entry point.

11.2 SPECIFIC REQUIREMENTS

 

11.2.1     NATURAL PRODUCTS

  • Quantity of samples submitted must be:
    1. a minimum of 6 separate containers of all dosage forms with total contents of not less than 200 g or 200 mL; OR
    2. a minimum of 60 pieces of plasters or patches with total of not less than 200g. 
  • Centre For Quality Control will conduct testing for Heavy Metals, Microbial Contamination Test, Disintegration Test, Uniformity Of Weight and screening for adulteration for the samples submitted.
  • The result of the tested sample is final and there is no provision for appeal.

 

11.2.2     PHARMACEUTICAL PRODUCTS

                        (Upon request from NPRA)

  • An official certificate of analysis and the recent shelf-life specification from the manufacturer for the same batch of sample must be submitted with the sample.
  • Quantity of samples submitted must be in accordance with the quantity requested.
  • Other materials such as HPLC columns, reagents, etc must be submitted when requested.
  • Reference standards are required to be submitted along with the pharmaceutical products. Requirements for these reference standards are as follows:
    1. The type & quantity of reference standards submitted must be in accordance with the type & quantity requested;
    2. 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 can be accepted;
    3. All reference standards must be accompanied by an official certificate of analysis for the same batch with the stated purity (as is, dried, anhydrous etc.) and all other relevant information (water content, loss on drying etc.);
    4. All reference standards must be properly labeled with name, batch number, purity and expiry date;
    5. All reference standards must be submitted in small sealed air-tight amber glass containers.


 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 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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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Wednesday 12 December 2018, 16:48:53.
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