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Frequently Asked Questions (FAQS) About Foreign Gmp Inspection On Manufacturers Of Pharmaceutical Products By National Pharmaceutical Regulatory Agency (NPRA)

1. WHY IS FOREIGN GMP INSPECTION REQUIRED?

The Control of Drugs and Cosmetics Regulations 1984 (CDCR 1984) requires that the standard of manufacture and quality control of medicinal products manufactured outside Malaysia be taken into consideration before the products are registered with Drug Control Authority (DCA). NPRA as the secretariat to the DCA is responsible for ensuring all manufacturers of registered products are able to provide acceptable evidence that the manufacturing premises conform to current GMP requirements.WhereNPRA is unable to verify the GMP compliance status of any foreign manufacturer(s) through acceptable documentary evidence, a GMP inspection shall be conducted.

2. WHAT IS CONSIDERED AS AN ACCEPTABLE GMP EVIDENCE?

A GMP evidence may be in the form of a GMP certificate or GMP inspection report. The GMP evidence must:

·         Be issued by a recognised National Drug Regulatory Agency (NDRA),

·         Has a validity period that is still current (i.e. a validity period of at least 6 months),

·         Provides the correct manufacturer’s name and address of manufacturing site

And

  • Specify the dosage form class OR the facility used to manufacture the dosage form was covered during the inspection.

3. WHICH NATIONAL DRUG REGULATORY AGENCY (NDRA) IS RECOGNISED BY NPRA?

Starting 1 July 2018,the NDRA recognised are:

·         Any PIC/S Participating Authority (as listed in PIC/S website).

·         ASEAN NDRA that is included as a Listed Inspection Service under the ASEAN Sectoral Mutual Recognition Arrangement (MRA) for GMP Inspection of Manufacturers on Medicinal Products.

·         NDRA that has a cooperation agreement such as Mutual Recognition Agreement (MRA) with PIC/S.

4. HOW DO I MAKE AN APPLICATION FOR FOREIGN GMP INSPECTION?

An application can be submitted through BPFK 501 form (Foreign GMP Inspection Application form) which is available on NPRA website 

5. WHO CAN MAKE AN APPLICATION FOR FOREIGN GMP INSPECTION?

An application must be made by a Malaysian registered company (i.e. Product Registration Holder, PRH) acting on behalf of the foreign manufacturer.

6. WHAT SHOULD BE DONE IF THERE IS A CHANGE IN PRODUCT REGISTRATION HOLDER (PRH) AFTER APPLICATION HAS BEEN SUBMITTED? CAN THE APPLICATION BE TRANSFERRED TO THE NEW PRH?

No, the application is not transferable to the new PRH. The previous PRH which submitted the application must make arequest for withdrawal of the application in writing and the new PRH is required to submit a new application together with a processing fee of RM5,000.00. Please note that the processing fee for the withdrawn application will not be refunded (refer Q7).

7. WHAT ARE THE COSTS INVOLVED FOR A FOREIGN GMP INSPECTION APPLICATION?

There are 3 types of fees as listed in the following table.

Type of Fee

Amount (RM)

Refundable

Due date

Payable to

Processing fee

5,000.00

No

Upon submission of BPFK 501 form

Biro PengawalanFarmaseutikalKebangsaan / AgensiRegulatoriFarmasi Negara, Kementerian Kesihatan Malaysia

Inspection fee

20,000.00

No

At least 30 days before inspection

Inspection expenses

Will be prepared by NPRA

Yes (refer to Guidance Document for further information)



According to letter of payment

KetuaSetiausaha Kementerian Kesihatan Malaysia

All payments must be made in form of a banker’s cheque.

8. WHAT ARE THE DIRECTIVES ISSUED BY THE DIRECTOR PHARMACEUTICAL SERVICES RELATING TO REQUIREMENT FOR GMP EVIDENCE SUBMISSION FOR REGISTRATION OF PHARMACEUTICAL PRODUCT?

For pharmaceutical product, the requirement for GMP evidence submission are laid down in the following directives issued by the Director Pharmaceutical Services:

·         Bilangan 1 Tahun 2012 – DirektifMengenaiSyaratPendaftaranProdukFarmaseutikal Dari Luar Negara BerkaitanKeperluanAmalanPerkilanganBaik (APB).

·         Bilangan 1 Tahun 2016 – DirektifMengenaiKeperluanPemeriksaanAmalanPerkilanganBaik (APB) Luar Negara BagiTujuanPendaftaran/ PendaftaranSemulaProdukFarmaseutikalBerdaftardenganPihakBerkuasaKawalanDadah (PBKD).

·         Bilangan 11 Tahun 2016 – DirektifMengenaiPenerimaanPengesahanPematuhanAmalanPerkilanganBaik (APB) BagiTujuanPendaftaranSemulaProdukFarmaseutikalBerdaftardenganPihakBerkuasaKawalanDadah (PBKD).

·         Bilangan 4 Tahun 2018 - DirektifMengenaiPenerimaanPengesahanPematuhanAmalanPerkilanganBaik (APB) BagiPengilangFarmaseutikalBagiTujuanPendaftaranBaru/ PendaftaranSemulaProdukFarmaseutikalBerdaftardenganPihakBerkuasaKawalanDadah (PBKD).



Starting 1 July 2018, please refer to directive Bilangan 4 Tahun 2018.

Directives can be accessed from NPRA website – http://npra.moh.gov.my.

9. WHICH STANDARD DOES NPRA USE TO ASSESS MANUFACTURER’S GMP COMPLIANCE STATUS?

Malaysia became the 26th member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) since 1st January 2002. Hence, NPRA adopts the current PIC/S Guide to GMP for Medicinal Products and its Annexes for GMP inspection. Additionally, the Malaysian Guideline on Good Distribution Practice lays down the requirements for products’ storage and distribution.

10. DOES NPRA CONDUCT FOREIGN GMP INSPECTION ON ALL CATEGORIES OF MANUFACTURING FACILITY?

As per the requirement stated in the directive,foreign GMP Inspection is conducted mainly on manufacturers of pharmaceutical products. Pharmaceutical product is defined as product whose product registration number (i.e. MAL number) contains the letter A/X. These presently include products in the following categories; new drug products, biologics and generics (scheduled and non-scheduled poison).The scope of foreign GMP inspection is not extended to veterinary products.

11. CAN I INVITE NPRA TO CONDUCT FOREIGN GMP INSPECTION ON MY FACILITY?

Please note that inspection conducted by NPRA is for the sole purpose of product registration with DCA. Hence, inspection will be conducted as needed and not based on invitation by companies.

12. WHEN SHOULD I MAKE AN APPLICATION FOR FOREIGN GMP INSPECTION?

An application for inspection should be made where the foreign manufacturer does not have a GMP evidence that is acceptable by NPRA. Examples are;

·         Manufacturer isnot located on a site within jurisdiction of a PIC/S Participating Authority (e.g. India, China, Pakistan, Bangladesh) and has never been inspected by any PIC/S PA.

·         Manufacturer isnot located on a site within jurisdiction of a PIC/S Participating Authority (e.g. India, China, Pakistan, Bangladesh), has been inspected by any PIC/S PA but the GMP evidence has already expired OR has a validity of less than 6 months ORthe scope of inspection did not cover the product to be registered with DCA.

·         Manufacturer is located in an ASEAN member country but the local NDRA is not included as a Listed Inspection Service under the ASEAN Sectoral MRA (e.g. Vietnam, Philippines, Cambodia) and has never been inspected by any PIC/S PA.

13. A FOREIGN MANUFACTURER WAS INSPECTED BY NPRA PREVIOUSLY AND THE GMP COMPLIANCE STATUS IS EXPIRING SOON, SHOULD I SEND IN AN APPLICATION?

Application should only be made if there is a new product to be registered or product(s) to be re-registered. However, if the manufacturer has been inspected by other NDRA recognized by NPRA and has an acceptable GMP evidence, no application needs to be submitted to NPRA.

Please note that it remains the responsibility of PRH to ensure that theGMP compliance status of the foreign manufacturer is maintained throughout product registration period.

14. DOES NPRA CONDUCT A ROUTINE INSPECTION ON FOREIGN MANUFACTURER?

No. Currently, NPRA only conducts pre-certification inspection on foreign manufacturers.

15. A FOREIGN MANUFACTURER WAS INSPECTED BY NPRA PREVIOUSLY AND THE GMP COMPLIANCE STATUS WAS CONCLUDED AS UNACCEPTABLE. RECENTLY, THE SAME FACILITY WAS INSPECTED BY OTHER RECOGNISED NDRA AND A GMP CERTIFICATE WAS ISSUED. CAN THIS BE USED FOR PRODUCT REGISTRATION WITH DCA?

The GMP certificate may be accepted upon satisfactory review of other additional documents such as GMP inspection report.

16. IF A FOREIGN MANUFACTURER PRODUCES STERILE AND NON-STERILE PRODUCTS WITHIN THE SAME SITE, HOW MANY INSPECTIONS ARE REQUIRED?

Inspection of sterile and non-sterile facility are conducted separately. Hence, two separate applications need to be submitted.

17. IF MULTIPLE APPLICATIONS ARE SUBMITTED FOR THE SAME MANUFACTURING SITE, WILL THE INSPECTIONS BE CONDUCTED AT THE SAME TIME?

No, the inspections may be carried out separately.

18. HOW MANY DAYS DOES NPRA NEED TO CONDUCT AN INSPECTION?

Generally, it takes three days to conduct inspection on non-sterile facility and five days for sterile facility. However, the number of days may varydepending on nature of products, size of premise and scope of inspection, among other things.

19. CAN FOREIGN MANUFACTURER REQUEST FOR THE INSPECTION TO BE POSTPONED TO A LATER DATE?

Request for postponement must be submitted in writing. However, NPRA has the authority to terminate the application (i.e. inspection) if the manufacturer is unable to accommodate the proposed inspection date after the date has been confirmed. Where inspection expenses have been paid, applicant may request for a refund.

20. CAN THE SCOPE OF INSPECTION BE CHANGED (e.g. ADDITIONAL PRODUCTS/DOSAGE FORMS/ PRODUCT TYPES/MANUFACTURING LINES/MANUFACTURING BLOCKS etc.)?

An inspection is planned based on the details provided during submission of application and the scope of inspection would have been determined prior to preparation of inspection expenses which is affected by duration of inspection. Since changes of inspection scope may have an implication on duration of inspection, request for changes after inspection expenses has been prepared is generally NOT considered.

21. WHAT HAPPENS AFTER AN INSPECTION IS COMPLETED?

Outcome of the GMP inspection will be tabled to the Committee of Evaluation of Inspection Premises. A GMP inspection report will be issued to the manufacturer through PRH.For inspection whose GMP compliance is concluded as acceptable, GMP certificate will be issued upon application.

For inspection whose GMP compliance is concluded as unacceptable, the manufacturer is not required to submit a CAPA report as there will be no further consideration or appeal for the GMP compliance status of the manufacturer. Applicant is required to submit a new application for NPRA to conduct another inspection on the manufacturing facility.

22. WHERE CAN I FIND MORE INFORMATION ABOUT NPRA’S FOREIGN GMP INSPECTION?

NPRA has prepared Guidance Document Foreign GMP Inspection which is downloadable from NPRA’s website (Garis Panduan or Guidelines Central Section).