Malaysia Issues Directive for Physical Testing for Lot Release Activities for Vaccine and Plasma Products

On 12 May 2020,  the National Pharmaceutical Regulatory Division (NPRA) of Malaysia  has announced a directive by the Director of Pharmacy Services pertaining to physical testing for Lot release activities for registered plasma product and each vaccine  imported by Malaysia as per directive Bill(9) BPFK/PPP/07/25 Jid.4.

Pursuant to Directive No. 9 of 2020, physical testing depends on the form of the dosage of the vaccines and plasma products.  For example, appearance test and particulate contamination (visible particles) are to be carried out on parenteral fluid. Appearance, Solubility, and particulate contamination (visible particles) on reconstituted finished product tests are to be carried out on freeze-dried or Iyophilized powder.

The increase in these physical testing requirements has been updated accordingly in the Guidance Document for Biological Product Lot Release in Malaysia.

The directive also states that the registrar shall submit 3 units of the product together with the diluent
(where applicable) for each cluster according to the time period. For instance, in the event the warehouse is located in Klang Valley ,the registrant has to submit the product within one(1) working day upon the cold network inspection.

The NPRA will also issue a  Lot Release certificate on vaccine clusters and plasma products if all four Lot Release requirements (including physical testing) are being complied with. On the contrary, if one of these requirements is not followed, a Notification of Non-Compliance will be issued and the vaccine batch and plasma products involved shall be disposed of in Malaysia.

The document has also indicated that the duration for  Lot Release certificate issuance will still take six (6) working days after the vaccine and plasma products have arrived at the product warehouse.

For more information pertaining to the directive, please refer to  https://www.npra.gov.my/easyarticles/images/users/1048/gambar/DIREKTIF-KEPERLUAN-MENJALANKAN-UJIAN-FIZIKAL.pdf