Representative from Task Force for Vaccine Lot Release National - - PowerPoint PPT Presentation

Ms Maslinda Mahat

Representative from Task Force for Vaccine Lot Release National Pharmaceutical Control Bureau, Ministry of Health Malaysia

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 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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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

12 ISSUES PUNITIVE RESPONSIBILITIES Non-compliant vaccine

• Vaccine not released
• nto 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 Monovalent 5 9 5 7 10 3 Polyvalent 2 3 2 3

9 25 11 14 16 6 4 16 4 4 4 5 9 5 7 10 3 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 documents

received

• No. of VLR documents

received 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 application

received

• No. of CC inspection

conducted

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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 application

received

• 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)

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• 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

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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 22

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 application

received

• No. of vaccine

consignment released

• No. of vaccine

consignments 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. 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

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ANY QUESTIONS?

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THANK YOU