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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
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Drug Control Authority Meeting conducted on 28th 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.
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Drug Control Authority Meeting conducted on 24th November 2014 has decided:
Vaccine Lot Release in Malaysia will be implemented starting 1st 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 wholesaler.
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Review of Lot Summary Protocol
Cold chain inspection
Centre for Quality Control, NPCB Centre for Compliance & Licensing, NPCB Kedah Pharmacy Enforcement Division* (*importation via Penang Int. Airport)
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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
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8
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Type of
Vaccine
CC Inspection &
review of LSP CC Inspection only
West
Malaysia
East
Malaysia
West
Malaysia
East
Malaysia
Monovalent RM300/
lot
RM600/
lot
RM200/
lot
RM500/
lot Polyvalent
RM600/
lot
RM900/
lot
Combination RM1000/
lot
RM1300/
lot
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ACTIVITIES TIMELINE
Submission of VLR documents Not less than 14 working days before product arrival
Payment for VLR fee Within 14 working days before product arrival
Cold chain inspection Within 2 working days after product arrival
Issuance of Lot Release Certificate by NPCB
Within 6 working days after product arrival
Submission of evidence of collection for disposal in the event of non-compliance
Within 30 days after issuance of
notification of non- compliance
Submission of evidence of disposal in the event of non-compliance
Within 90 days after date of
collection for disposal
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ISSUES PUNITIVE RESPONSIBILITIES
Non-compliant vaccine
Vaccine not released onto market
Vaccine to be disposed
All stakeholders shall ensure vaccine supply not affected
Non-compliant vaccine importer
Revocation of import license
Holder shall ensure vaccine supply not affected
Non-compliant vaccine wholesaler
Revocation of wholesale license
Holder shall ensure vaccine supply not affected
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Findings from review of Lot Summary Protocol (LSP)
Findings from cold chain inspection
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NO. OF VLR APPLICATION RECEIVED (Total = 81 applications)
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
Polyvalent 0 0 2 3 2 3
9
25
11
14
16
6
4
16
4 4 4
0
5
9
5
7
10
3
0 0
2 3
2 3
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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
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NO. OF VLR DOCUMENTS SUBMITTED 14 WORKING
DAYS BEFORE PRODUCT ARRIVAL (Timeline: 14 working days before product arrival)
Jul Aug Sept Oct Nov Dec
9
25
11
14
16
6
3
11
4 5 5
2
No. of VLR documentsreceived
No. of VLR documentsreceived within timeline
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NO. OF WORKING DAYS TAKEN BY PRODUCT HOLDER TO SUBMIT VLR DOCUMENTS
BEFORE PRODUCT ARRIVAL
30
17
28
6
14 working days before or more
11- 13 working days before
6 - 10 working days before
1 - 5 working days before
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FINDINGS FROM CC INSPECTION
9
25
11
14 16
6
7
20
8
12 11
5
Jul Aug Sept Oct Nov Dec
No. of CC Inspection conducted
No. of VLR applicationreceived
No. of CC inspectionconducted
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FINDINGS FROM CC INSPECTION
31
6
15 13 14
2
22
4
12 11 12
2
No. of CCI according to vaccine importers
No. of VLR applicationreceived
No. of CCI conducted
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TIME TAKEN TO CONDUCT CC
INSPECTION AFTER PRODUCT ARRIVAL
27; 42%
28; 44%
5; 8% 4; 6%
Same Day
Next Day (am)
Next Day (pm)
Next 2 day
FINDINGS NO. OF
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
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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
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FINDINGS FROM CC INSPECTION
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) Frozen vaccine incident (2)
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NO. OF WORKING DAYS TAKEN TO ISSUE
LOT RELEASE CERTIFICATE (Timeline: 6 WD after product arrival)
12; 16%
52; 67%
13; 17%
1 working day 2 - 6 working days More than 6 working days
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NO. OF VACCINE CONSIGNMENTS
RECEIVED / REJECTED
Jul Aug Sept Oct Nov Dec
9
25
11
14
16
6
9
25
11
14
12
6
1
4
No. of VLR applicationreceived
No. of vaccineconsignment released
No. of vaccineconsignments rejected
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)
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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 (WHO/IVB/06.10)
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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 11th May 2015 (Letter from NPCB dated 11th November 2014: Keperluan Menghantar Dokumen Packaging and Shipping Validation Bagi Aktiviti Vaccine Lot Release di Malaysia)
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IMPORTANT HIGHLIGHTS
Review of Lot Summary Protocol: i. Puan Nor Hayati Abdul Rahim (03-7801 8478) ii. Puan Maslinda Mahat (03-7801 8494) iii. [email protected] Cold chain inspection: i. Cik Nora Ashikin Mohd Ali (03-7883 5568) ii. En. Ahmad Syamsury Sulaiman (03-7883 5569) iii. [email protected]
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ANY QUESTIONS?
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THANK YOU
