who api prequalification procedure

WHO Prequalification of APIs – TBS, Oct 20121 |

WHO API prequalification procedure

Antony Fake PhDWHO Prequalification of Medicines

Programme


Overview

• Introduction

• Prequalification Process

• Achievements

• Challenges


Abbreviations

API – Active Pharmaceutical Ingredient

FPP – Finished Pharmaceutical Product

API PQ – API Prequalification

APIMF – Active Pharmaceutical Ingredient Master File (DMF) CPQ – Confirmation of API PQ Document SRA – Stringent Regulatory Authority GMP – Good Manufacturing Practice PQP – Prequalification of Medicines Programme


Prequalification of Medicines website

http://www.who.int/prequal


API Prequalification

It is a scheme for manufacturers of APIs.

It is for selected APIs only, reflecting those APIs present in medicinal products invited for FPP prequalification.

It seeks to verify and recognise APIs that are of good quality and manufactured in compliance with GMP.

It seeks to facilitate sourcing of quality APIs by FPP manufacturers of essential medicines leading to the greater availability.

It offers to national regulatory agencies (NMRAs) information on the quality of these APIs for consideration during their assessment decision making.


How are APIs Prequalified

Invitation

Application

Assessment(GMP)

Assessment(Quality)

Decision

Publishing


4th Invitation for EOI

Abacavir, Atazanavir, Darunavir, Didanosine, Efavirenz, Emtricitabine, Etravirine, Lamivudine, Lopinavir, Nevirapine, Raltegravir, Ritonavir, Stavudine, Tenofovir, Zidovudine

HIV

Amodiaquine, Artemether, Artesunate, Dihydroartemisinin, Lumefantrine, Mefloquine, Piperaquine, Pyrimethamine, Sulfadoxine, Pyronaridine

Anti-malarial

Amikacin, Capreomycin, Cycloserine, Ethambutol, Ethionamide, Isoniazid, Kanamycin, Levofloxacin, Moxifloxacin, Ofloxacin, Para-Aminosalicylic Acid (PAS), Prothionamide, Pyrazinamide, Rifampicin, Streptomycin, Terizidone

Anti-tuberculosis

Desogestrel, Estradiol, Ethinylestradiol, Etonogestrel, Levonorgestrel, Medroxyprogesterone, Mifepristone, Misoprostol, Norethisterone, Norgestrel, Oxytocin

Reproductive health

Diethylcarbamazine, Mebendazole Neglected Tropical Diseases

Zinc sulphate Treatment of Diarrohea



Invitation

Application

Assessment(GMP)

Assessment(Quality)

Decision

Publishing


Assessment – GMP

• Inspections performed previously by WHO, a member of PIC/S, or an SRA.

• Inspection must have occurred within 3 years of application.

• Inspections must be API specific.

Assessment of GMP compliance at the site of API manufacture takes into account:

The WHO will perform an inspection if, after assessment and requests for information, GMP compliance can not be established.


Assessment of GMP

An SRA is a medicines regulatory authority in a country that is:

a member of the ICH: Japan, USA, EU member; or

an ICH Observer, e.g. Swissmedic, Health Canada; or

associated with an ICH member through a legally binding mutual recognition agreement, e.g. Australia, Iceland, Liechtenstein, Norway…etc.



Invitation

Application

Assessment(GMP)

Assessment(Quality)

Decision

Publishing


Quality Assessment

Involves the assessment of the APIMF (Drug Master File) submitted by the applicant.

Expected technical content and assessment approach follows key international guidance and can be located in the published guideline :

Guideline on submission of documentation for a multisource (generic) finished pharmaceutical product (FPP): quality part.

http://www.who.int/prequal/info_general/documents/generic_guide/GenericGuideline_Quality.pdf.

In some cases this assessment has already been completed for APIMFs already used in the FPP prequalification procedure.

http://www.who.int/prequal/info_general/documents/generic_guide/GenericGuideline_Quality.pdf





Invitation

Application

Assessment(GMP)

Assessment(Quality)

Decision

Publishing


Publishing

List of PQ APIsWebsite (Public)

Confirmation Document (Private)

+WHOPIRs

Website (Public)


WHO List of Prequalified APIs

● WHO reference number.● INN name.● Date of prequalification.● Name of the applicant● Sites of API manufacture.● The APIMF version number.● The API specification version number.

● The primary and secondary packaging components.

● The assigned re-test period.● The recommended storage

conditions.● Confirmation of API PQ document

issue date

Intended for: UN agencies, National medicine authorities, FPP manufacturers, public

Publically available


Confirmation of API PQ document

The assigned WHO reference number. The INN name of the active pharmaceutical ingredient. API manufacturer company name. The API specification version number. A copy of the API specifications. The assigned re-test period. The recommended storage conditions. A copy of the assay and related substances test methods.

Provided to the API manufacturer for distribution at their discretion

Intended for: UN agencies, National medicine authorities, FPP manufacturers


API Prequalification Successes

October 2012 1 November 2011 1 April 2011

64 29 8 Total number of applications

23 5 2 Number of PQ APIs

RH TB Malaria HIV

5 16 26 17 Total number of applications

- 6 15 2 Number of PQ APIs


• Roughly half of the applications made used APIMFs not previously used in support of PQ FPPs.

• Half of these new applications came from China, compared to less than 10% in support of PQ FPPs.

• Submission of applications from emerging manufacturers.



• A higher than expected number of submission of applications in RH area.

• It is noted that there are submissions of applications from manufacturers who currently manufacture FPPs domestically.

• Recognition of API PQ as one means of satisfying API requirements in Malaysia.

• Sharing of an assessment report from the EDQM to permit an abridged assessment.



Challenges

• Increasing recognition of the PQ scheme among manufacturers.

• Maximising the value of the PQ assessments for national regulatory agencies - Increasing the value of API PQ to manufacturers.

• Maximising use existing evidence of Quality and GMP for manufacturers seeking prequalification.

• Formalising application processes – dealing with increased workload.


Thank you

If you have any further questions, or

You have ideas or are interested in greater involvement in API PQ please feel free to contact me at:

[email protected]

who api prequalification procedure

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