Biro Pengawalan Farmaseutikal Kebangsaan (bpfk)

BPFK- 504

(Ver.08/2014)

Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) National Pharmaceutical Control Bureau (NPCB) Lot 36, Jalan Universiti 46200 Petaling Jaya, Selangor. No. Tel. Tel. No. : 03-78835400 (ext 5565) No. Faks. Fax No. : 03-79571200 Laman Web Website : http://www.bpfk.gov.my	BORANG PERMOHONAN PEMERIKSAAN AMALAN PERKILANGAN BAIK (APB) APPLICATION FORM FOR GOOD MANUFACTURING PRACTICE (GMP) INSPECTION
	Untuk Kegunaan Unit Kewangan Sahaja For Finance Unit Use Only Tarikh Diterima Date Received	Untuk Kegunaan PKP Sahaja For CCL Use Only Tarikh Diterima Date Received Wang Pos/Kiriman Wang/Draf Bank Postal Order/Money Order/Bank Draft .............................................................................

Borang permohonan ini perlu dilengkapkan oleh syarikat pengilang yang memohon pemeriksaan APB bukan rutin bagi premis pengilang baru/line pengilangan baru/ pensijilan ke atas premis yang tidak dikawal oleh Pihak Berkuasa Kawalan Dadah (PBKD) dan fasiliti kesihatan yang tidak dilesenkan. Borang ini dikecualikan ke atas pengilang berlesen/pengilang kosmetik yang diperiksa secara rutin oleh Pusat Komplians dan Pelesenan (PKP),BPFK. NOTA: Borang permohonan yang tidak lengkap tidak akan diproses.

This is form should be completed in full by a manufacturing company that would like to request for a non-routine GMP Inspection for e.g. GMP inspection on a new manufacturing premise/ new manufacturing line certification of premises that are not controlled by the Drug Control Authority (DCA) and healthcare establishments. This form is not applicable for licensed manufacturers/ cosmetic manufacturers that are subjected to routine GMP inspection by the Center for Compliance & Licensing (CCL), NPCB. NOTE: INCOMPLETE APPLICATION FORM WILL NOT BE PROCESSED.

Bahagian I: Maklumat Pemohon Part I: Particulars of Applicant
Nama Pemohon Name of Applicant			No. Kad Pengenalan I/C No.
Nama Syarikat Name of Company
Alamat Syarikat Address of Company
Bahagian II: Maklumat Pengilang / Premis Pemeriksaan Part II: Particulars of Manufacturer
Nama Pengilang Name of Manufacturer
Alamat Pengilang Address of Manufacturer
No. Telefon Telephone No.			No. Faks Fax No.
E-mel Email			Laman Web (jika ada) Website (if any)

Bahagian III: Maklumat Bentuk Dos Produk Yang Dikilangkan (Sila tanda yang berkenaan) Part III: Particulars of Dosage Form of Product Manufactured (Please tick which is appropriate)
Farmaseutikal (Racun & Bukan Racun) Pharmaceutical (Poison & Non-Poison)	Tablet (Tablet) Serbuk/Granul (Powder/Granule) Persediaan Steril (LVP/SVP/Gel) (Sterile Preparation) Pil (Pill) Kapsul (Capsule)	Sachet (Sachet) Losyen (Lotion) Salap (Ointment) Gel (Gel) Krim (Cream) Cecair internal/Cecair eksternal (Liquid internal/external)	Lain-lain. Sila nyatakan ................................. (Others. Please specify ................................)
Bioteknologi / Biologikal Biotechnology/Biological	Persediaan Steril (LVP/SVP/Gel) (Sterile Preparation)	Lain-lain. Sila nyatakan ................................. (Others. Please specify ................................)
Tradisional Traditional	Tablet (Tablet) Serbuk/Granul (Powder/Granule) Kapsul (Capsule) Gel (Gel) Pil (Pill) Krim (Cream)	Sachet (Sachet) Losyen (Lotion) Salap (Ointment) Cecair internal/Cecair eksternal (Liquid internal/external)	Lain-lain. Sila nyatakan ................................. (Others. Please specify ................................)
Suplemen Kesihatan Health Supplement	Tablet (Tablet) Serbuk/Granul (Powder/Granule) Kapsul (Capsule)	Sachet (Sachet) Cecair internal/Cecair eksternal (Liquid internal/external)	Lain-lain. Sila nyatakan ................................. (Others. Please specify ....................................)
Veterinar* Veterinary Racun (Poison) Bukan Racun (Non-poison) *Rujuk Pengawalan Bahan Tambahan Makan Haiwan/Feed Additive Termasuk Produck Suplemen Kesihatan/Dietary Supplemens dan Produk Herbal/Natural	Tablet (Tablet) Serbuk/Granul (Powder/Granule) Persediaan Steril (LVP/SVP/Gel,dll) (Sterile Preparation)	Kapsul (Capsule) Sachet (Sachet) Cecair internal/eksternal (Liquid internal/external)	Lain-lain. Sila nyatakan ........................... (Others. Please specify ................................)
Bahan Aktif Farmaseutikal (Active Pharmaceutical Ingredient)	Serbuk/Granul (Powder/Granule) Persediaan Steril (LVP/SVP/Gel,dll) (Sterile Preparation)	Sachet (Sachet) Cecair internal/eksternal (Liquid internal/external)	Lain-lain. Sila nyatakan ................................. (Others. Please specify ....................................)
Kosmetik Cosmetic	Serbuk/Granul (Powder/Granule) Cecair eksternal (Liquid external)	Losyen (Lotion) Gel (Gel) Krim (Cream) Gincu (Lipstick) Aerosol	Lain-lain. Sila nyatakan ........................... (Others. Please specify ....................................)
Fasiliti Kesihatan Healthcare Establishment	CDR Non-CDR : TPN/IV Admixture/ Eye Drop	Radiopharmaceutical : Kit based/ Radioiodine/ Blood Radiolabelled
Lain-lain Others	Sila nyatakan Please specify	....................................... .......................................

Bahagian IV: Jenis Pemeriksaan Amalan Perkilangan Baik (APB) (Tandakan 1 jenis sahaja) Part IV: Types of Good Manufacturing Practice (GMP) Inspection (Tick 1 only)
Pra-pelesenan Pre-licensing Verifikasi Verification Pra-kelulusan Pre-approval		Pemeriksaan awal (Premis kosmetik sahaja) Initial inspection (Cosmetic premises only) Pra-pensijilan Pre-certification			Pra-kualifikasi (untuk fasiliti kesihatan sahaja) Pre-qualification (for healthcare establishment only)
Definisi /Definition: Pra-pelesenan (Pre-licensing) :		pemeriksaan yang dijalankan ke atas premis pengilang yang baru dan belum pernah dilesenkan (inspection conducted on new premises that have never been licensed).
Verifikasi (Verfication) :		pemeriksaan yang dijalankan susulan daripada tindakan punitif yang telah dikenakan (inspection conducted following a punitive action).
Pemeriksaan awal (Intial Inspection) :		pemeriksaan yang dijalankan ke atas premis pengilang kosmetik yang baru, yang mana tidak termasuk di dalam jadual pemerikaan rutin (inspection conducted only on new cosmetic premises which is not in the Routine Inspection Schedule).
Pra-pensijilan (Pre-certification) :		pemeriksaan yang dijalankan ke atas premis pengilang bagi produk yang belum dikawal oleh Pihak Berkuasa Kawalan Dadah [PBKD] (inspection conducted on premises that manufacture products that are not regulated by Drug Control Authority, DCA).
Pra-kelulusan (Pre-approval) :		pemeriksaan yang dijalankan ke atas ‘line’ pengeluaran pengilang yang berlesen (inspection conducted on a new production line of licensed manufacturer).
Pra-kualifikasi (Pre-qualification) :		Berkait dengan Amalan Penyediaan Baik (GPP) dan dijalankan ke atas fasiliti hospital farmasi dan Jabatan Perubatan Nuklear yang baru dibina atau diubahsuai (related to Good Preparation Practice (GPP) and the inspection is conducted on new/renovated pharmacy hospital and nuclear medicine facility).
Bahagian V: Dokumen Sokongan Yang Diperlukan Part V: Supporting Documents Required
Fail Induk Pengilang Site Master File Sijil Pendaftaran Suruhanjaya Syarikat Malaysia (SSM) Registration of Company Certificate			Sebarang Urusan surat-menyurat bersama PKP Any correspondence letter with CCL previously. Surat Kelulusan Pelan Aliran Kilang dari BPFK (Jika ada) Layout plan approval letter from NPCB (If any)
Bahagian VI: Fi Pemeriksaan APB (Untuk Pengilang Tradisional/ Suplemen Kesihatan/ Kosmetik Sahaja) Part VI: GMP Inspection Fee (Only for Traditional/Health Supplement/Cosmetic Manufacturer)
Fi Pemeriksaan Inspection Fee RM1,000	Pembayaran (tidak dikembalikan) hendaklah dibuat dalam bentuk Wang Pos/Kiriman Wang/Draf Bank atas nama BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN. Bagi bayaran dalam bentuk tunai/kad kredit, sila berhubung dengan Unit Kewangan, Pusat Pentadbiran, BPFK. **Nota: Pembayaran pemeriksaan bagi premis pengilang selain daripada yang dinyatakan perlu di bayar selepas pemeriksaan dijalankan (pasca-bayar) Fee (not refundable) should be submitted in the form of Postal Order/Money Order/Bank Draft made payable to BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN. For payment in the form of cash or credit card, please contact Finance Unit, Centre for Administration, NPCB. **Note: Payment of inspection for other categories as stated above will be after inspection is conducted (post-paid)
Bahagian VII: Perakuan Pemohon Part VII: Applicant’s Declaration
Saya mengakui dan bersetuju bahawa / I hereby declare and agree that Maklumat yang diberikan adalah benar dan lengkap /Information provided are true and complete; Tujuan permohonan pemeriksaan ini telah difahami /Understand the purpose of this application; Kaedah pembayaran kepada BPFK telah disertakan (Rujuk Bahagian VI / Mode of payment to NPCB has been attached (refer Part VI; Saya akan sentiasa memberi kerjasama untuk mengemukakan dokumen tambahan jika diperlukan oleh BPFK / I will always cooperate and provide any additional documents if needed by NPCB.				Tandatangan & Cop Syarikat (jika ada) Signature & Company Stamp (if any) Tarikh: Date

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