Ms Maslinda Mahat Representative from Task Force for Vaccine Lot Release National Pharmaceutical Control Bureau, Ministry of Health Malaysia 1
Introduction Approaches for Vaccine Lot Release (VLR) in Malaysia Fee for VLR Timeline for VLR activities Punitive Actions Findings from Pilot Study Important highlights List of contact persons for VLR activities 2
Drug Control Authority Meeting conducted on 28 th May 2014 has decided: Vaccine Lot Release approaches will be conducted by: Review of Lot Summary Protocol AND Review of cold chain system monitoring Vaccine Lot Release shall be implemented as a PILOT STUDY for the period between 1 July – 31 Dec 2014. The decision on the implementation shall be made after the presentation of the Pilot Study Report. 3
Drug Control Authority Meeting conducted on 24 th November 2014 has decided: Vaccine Lot Release in Malaysia will be implemented starting 1 st January 2015, involving all registered imported vaccine in Malaysia. The approaches for conducting Vaccine Lot Release in Malaysia is remained . All timeline set for the activities is remained . The fee for Vaccine Lot Release will be imposed upon approval from Ministry of Health, Malaysia. Punitive action shall be imposed for non- compliant vaccine, vaccine importer and vaccine 4 wholesaler.
Review of Lot Cold chain Summary inspection Protocol Centre for Compliance & Licensing, NPCB Centre for Quality Control, NPCB Kedah Pharmacy Enforcement Division* (*importation via Penang Int. Airport) 5
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VLR documents to be submitted: VLR application form (available in NPCB website) Lot summary protocol Lot release certificate from country of origin Certificate of analysis for finished products Importing packing list* Airway bill* * Submission 2 working days before product arrival 7
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CC Inspection & CC Inspection only Type of review of LSP Vaccine West East West East Malaysia Malaysia Malaysia Malaysia RM300/ RM600/ Monovalent lot lot RM600/ RM900/ RM200/ RM500/ Polyvalent lot lot lot lot Combination RM1000/ RM1300/ lot lot 9
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ACTIVITIES TIMELINE Not less than 14 working days before Submission of VLR documents product arrival Within 14 working days before Payment for VLR fee product arrival Within 2 working days after product Cold chain inspection arrival Issuance of Lot Release Certificate Within 6 working days after product by NPCB arrival Submission of evidence of collection Within 30 days after issuance of for disposal in the event of non- notification of non- compliance compliance Within 90 days after date of Submission of evidence of disposal 11 in the event of non-compliance collection for disposal
ISSUES PUNITIVE RESPONSIBILITIES Vaccine not released All stakeholders shall Non-compliant onto market ensure vaccine supply Vaccine to be vaccine not affected disposed Holder shall ensure Non-compliant Revocation of import vaccine supply not vaccine importer license affected Revocation of Holder shall ensure Non-compliant wholesale license vaccine supply not vaccine wholesaler affected 12
Findings from review of Lot Summary Protocol (LSP) Findings from cold chain inspection 13
NO. OF VLR APPLICATION RECEIVED (Total = 81 applications) 25 16 16 14 11 10 9 9 7 6 5 5 4 4 4 4 3 3 3 2 2 0 0 0 July August Sept Oct Nov Dec Total 9 25 11 14 16 6 Combination 4 16 4 4 4 0 Monovalent 5 9 5 7 10 3 14 Polyvalent 0 0 2 3 2 3
FINDINGS FROM REVIEW OF LSP FINDINGS Poor compliance on timeline for documents submission Inconsistent information on the manufacturer’s address Information on testing methods and testing specifications were not updated Label and product information leaflet were not updated 15
NO. OF VLR DOCUMENTS SUBMITTED 14 WORKING DAYS BEFORE PRODUCT ARRIVAL (Timeline: 14 working days before product arrival) 25 16 14 No. of VLR documents received 11 11 No. of VLR documents 9 received within timeline 6 5 5 4 3 2 Jul Aug Sept Oct Nov Dec 16
NO. OF WORKING DAYS TAKEN BY PRODUCT HOLDER TO SUBMIT VLR DOCUMENTS BEFORE PRODUCT ARRIVAL 1 - 5 working days before 6 6 - 10 working days before 28 11- 13 working days before 17 14 working days before or more 30 17
FINDINGS FROM CC INSPECTION No. of CC Inspection conducted 25 16 20 No. of VLR application 14 received 11 No. of CC inspection 9 12 conducted 11 6 8 7 5 Jul Aug Sept Oct Nov Dec 18
FINDINGS FROM CC INSPECTION No. of CCI according to vaccine importers 31 22 15 No. of VLR application 14 13 12 12 11 received No. of CCI conducted 6 4 2 2 19
TIME TAKEN TO CONDUCT CC INSPECTION AFTER PRODUCT ARRIVAL 5; 8% 4; 6% 27; 42% Same Day Next Day (am) 28; 44% Next Day (pm) Next 2 day 20
FINDINGS FROM CC INSPECTION NO. OF FINDINGS INCIDENTS 1. Temperature excursion (out of 2 – 8°C) 19 2. Temperature excursion below freezing range 2 3. Deviation in vaccine amount stated in import packing list 2 4. Deviation in amount stated in VLR application form 2 5. Unseal of vaccine without the presence of CC inspector 1 6. Large consignment with only one data logger 1 7. Consignment with 215 carton but no data logger 1 8. Damaged vaccine due to damaged plastic seal 1 9. Use of CCM card for ice pack as coolant 1 21
FINDINGS FROM CC INSPECTION OTHER FINDINGS Poor planning on vaccine arrival time resulting cold chain inspectors waiting at warehouse Inability of product registration holder to submit documents on transportation and packing validation to support temperature excursion 22
NO. OF WORKING DAYS TAKEN TO ISSUE LOT RELEASE CERTIFICATE (Timeline: 6 WD after product arrival) 13; 17% 12; 16% 52; 67% 1 working day 2 - 6 working days More than 6 working days Reasons of delay in release for the 13 vaccine consignments: Delay in submission of supporting document during temperature excursion (5) Correspondence between NPCB and product holder on no. of final containers in LSP (4) Delay in providing feedback on: Deviation found in import packing list (2) 23 Frozen vaccine incident (2)
NO. OF VACCINE CONSIGNMENTS RECEIVED / REJECTED 25 25 No. of VLR application 16 received 14 14 12 11 11 No. of vaccine 9 9 consignment released 6 6 No. of vaccine 4 consignments rejected 1 Jul Aug Sept Oct Nov Dec 24
IMPORTANT HIGHLIGHTS 1) Temperature monitoring devices should be included in all vaccine shipments to document whether temperature limits has been exceeded*. 2) WHO recommends that one electronic temperature device is included in each and every international vaccine shipping cartons*. 3) WHO no longer recommends the use of vaccine Cold Chain Monitoring (CCM) card and/or freeze indicator for international shipping*. *Source: Guidelines on the International Packaging and Shipping of Vaccines, December 2005 (WHO/IVB/05.23) 25
IMPORTANT HIGHLIGHTS 4) Shake Test to be conducted to determine whether an adsorbed vaccine have been affected by freezing* Adsorbed vaccine: DPT, DT, TT, HepB, Hib liquid and/or combination of these* Shake test and sampling of the vaccine shall be conducted by NPCB officers. Two vials of unaffected vaccine from the same lot as the test vaccine will be used as a frozen control vaccine and non-frozen control vaccine. Sampled vaccine shall be disposed after the Shake test. *Source: Temperature sensitivity of vaccines, August 2006 26 (WHO/IVB/06.10)
IMPORTANT HIGHLIGHTS 5) Submission of VLR documents according to the timeline is mandatory (14 working days before product arrival). Vaccine lot which fail to comply to this requirement may face a delay in release. The importer shall commit to place the consignments under quarantine while pending release from NPCB. 6) Submission of Document for Packaging and Shipping Validation to NPCB to be made before 11 th May 2015 (Letter from NPCB dated 11 th November 2014: Keperluan Menghantar Dokumen Packaging and Shipping Validation Bagi Aktiviti Vaccine Lot Release di Malaysia) 27
ANY QUESTIONS? Review of Lot Summary Protocol: Puan Nor Hayati Abdul Rahim (03-7801 8478) i. ii. Puan Maslinda Mahat (03-7801 8494) iii. vaccinecqc@bpfk.gov.my Cold chain inspection: i. Cik Nora Ashikin Mohd Ali (03-7883 5568) ii. En. Ahmad Syamsury Sulaiman (03-7883 5569) iii. cc@bpfk.gov.my 28
THANK YOU 29
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