Pengalaman Industri Farmasi

dalam Aplikabilitas Tools (SPS dan Daftar Periksa)

dalam Pemantauan Penerapan Farmakovigilans

Dr Risa Anwar

Medical Director/Local Drug Safety Officer

Merck Serono-Indonesia

Pharmacovigilance (PhV) Inspection

What? Why? How? When?

What is an Audit?

A systematic and independent examination of activities to determine whether the evaluated activities were performed according to defined requirements.*

Key Words in Definition

• Systematic –organized, methodical, planned

• Independent –unbiased, no conflict of interest, objective

• Examination –assessment, evaluation, investigation

• Defined requirements –audit criteria, regulations, procedures

*This definition compiled from an extraction of ICH and ISO definitions.

PhV Inspection

The act by a competent authority of conducting an

official review of documents, facilities, records, quality

assurance arrangements, and any other resources that

are deemed by the competent authority to be related to

the PhV activities and that may be located at the site of

the QPPV or at other affiliates, or at other establishments

which the competent authority sees fit to inspect

Pharmacovigilance Inspection

by the BPOM

June 15, 2012

The MAH provides responses to findings and the Corrective Action, Preventative Action (CAPA) plan is

reviewed for acceptability*

RE

PO

RT

ING

A preliminary notification to the Marketing Authorisation Holder (MAH)

of statutory inspection is sent to the organisation, which includes a request for the Summary of Pharmacovigilance

Systems (SPS)

MAH supplies the SPSThe inspection dates

are confirmed with the MAH

PL

AN

NIN

G

Main inspection of the MAH takes place

INS

PE

CT

ION

After the inspection, a report of the findings is

issued to the MAH

Once CAPA acceptable, an

inspection closing letter is issued*

The Inspection Plan

Template

Ringkasan Sistem Farmakovigilans

(Summary Of Pharmacovigilance System)

Bagian 1 : Informasi Umum• Informasi Industri Farmasi

• Penanggung Jawab Farmakovigilans

• Regulatory Affairs

Bagian 2: Informasi Produk Yang Terdaftar2.1 Daftar Obat Terdaftar yang dimiliki (termasuk produk ekspor, jika ada)

2.2 Daftar obat yang pernah dibatalkan/dibekukan Nomor Ijin Edarnya

(NIE) karena Aspek Keamanan

2.3.Daftar Obat yang telah atau sedang diproses registrasi variasi terkait

perubahan informasi keamanan obat, dalam 2 (dua) tahun terakhir.

Bagian 3: Struktur Organisasi dan Sistem Farmakovigilans• Struktur Organisasi

• Unit/Fungsi Farmakovigilans

Template

Ringkasan Sistem Farmakovigilans

(Summary Of Pharmacovigilance System)

Bagian 4: Biodata dan Uraian Kerja (Job description)

Bagian 5: Perjanjian Kerjasama dengan pihak lain dalam hal lisensi,impor,

obat kontrak (toll manufacturing) &/ kegiatan farmakovigilans

Bagian 6: Studi Pasca Pemasaran (diisi jika ada)

6.1 Daftar Studi

Bagian 7: Kepatuhan Waktu Pelaporan

7.1 Laporan Spontan Kejadian Tidak Diinginkan ke Badan POM

7.2 Laporan Spontan Kejadian Tidak Diinginkan Serius pada Uji Klinik yang dilakukan

(apabila ada) ke Badan POM

7.3 Laporan PSUR

7.4 Perencanaan Manajemen Risiko (Risk Management Plans)

Apakah saat ini IF memiliki RMP yang sedang dilaksanakan?

Berikan penjelasan singkat

Template

Ringkasan Sistem Farmakovigilans

(Summary Of Pharmacovigilance System)

Bagian 8: Sistem Komputerisasi yang digunakan dalam Aktivitas

Farmakovigilans

8.1 Kondisi saat ini – Sistem global dan atau lokal

Bagian 9: Sistem Manajemen Mutu (Quality Management System)

9.1 List Pelatihan

9.2 List SOPs

9.3 List Audit Internal/eksternal

Bagian 10: Informasi Tambahan/ Lainnya

Why Perform PhV Inspection?

• To ensure compliance with company procedures and local / global

regulatory requirements

• To ensure company regulatory obligations / commitments are met

• Evolving regulatory requirements

• Increasing Regulatory Inspections –Internal detection of risk is

essential

• To identify process / quality improvements

Most importantly, pharmacovigilance inspection act as

one mechanism to ensure the safety of patients is maintained

How ?

Type of PhV System Audits

▫ Global PhV systems/processes

▫ Company Affiliates (i.e.,

Country Office, Marketing

Company)

▫ Marketing (Licensing) Partners

• Types of PhV Inspection

▫ Routine Inspection

▫ „For cause inspection‟

▫ Risk based Inspection

When?

• Always be ready for inspection/audit

• Do self/mock audit to assess readiness

• All documents and systems should be up to date with

regulation standards

• Know the key personnel and chain of command

Preparation

SPS submitted prior to inspection

(May 31, 2012)

BUT Now…………..

How can we be fully prepared for arrival of

Inspectors?

PhV System Audit Program

Planning and

Preparation

Conduct

ReportingCAPA

Follow-up

• Anticipate an inspection

• Comply with company procedures and external regulations on an ongoing basis

• Maintain current and historical procedures/guideline

• Ensure documentation is available, accurate and complete on an ongoing basis

• Ensure personnel training is current

• Maintain awareness of contracted functions

• Have a company / site inspection plan (and routinely test it)

▫ Identify a core inspection team

▫ Maintain a key contacts list including primary and back-up contacts

▫ Address logistical and administrative aspects (rooms, technology, etc.)

• Inspection readiness training for company personnel

• Mock Inspections / Mock Interviews

Preparing for Inspections

Before the Inspection

• Documents requested prior to inspection – to be provided on the

first day

• Local and Global Quality Documents

• Training Files

• Alert affiliates and make sure they have a dedicated contact on

call

• Key Contacts

▫ email addresses and phone numbers

• Train appropriate staff specifically for the inspection

• Opening Meeting to “kick off” the inspection

• Interviews with relevant personnel

• Document reviews

• Demonstration of activities (e.g. processing of an AE case)

• Tour of facilities (e.g. file storage and archiving)

• Closing meeting to discuss preliminary results

• Follow-up on outstanding questions / requests

Conduct of the Inspection

• Relax, don‟t panic!

• Listen carefully to the Inspector‟s questions

• Pause and formulate a proper response

• Request clarification to questions not understood

• Answer only what was asked

• Provide a clear, concise, and honest answer

• Only answer questions within your job responsibilities

During the Inspection

Document Review

• Appropriately labelled

• Filed in an easy to access format

• Includes documents requested

prior to the inspection

Documents ready

Documents Reviewed During Inspection

• Organization chart

• Job Desc –CV-training record

• Training records of non PhV

staffs

• PSUR

• ICSRs process

• Case files for ICSRs

• Clinical Trial

• List of products

• Risk Management

• Local SDEAs SOPs

• Data management

• Archiving

• Quality Assurance

• Regulatory affairs

• Many examples of evidence

e.g. you said you do this,

show me an example

• Ensure appropriate company personnel are present for

close out meeting

• Clarify misunderstandings

• Confirm reporting and response procedures

• Communicate corrective actions implemented during

the inspection

Close out Meeting

• Inspection report issued within defined timelines

• Executive Summary

• Description of Objectives and Scope of inspection

• Clear description of conditions observed

• Reference or criteria as the basis for the observation

• Quantification

• Assessment of cause and effect

• Judgment / Rating (e.g., Critical, Major, Minor, etc.)

• Areas of improvement

Reporting

CAPA (Corrective and Preventative Action)

▫ Evaluate the process and logistics

▫ Assess and understand root cause

▫ Develop CAPA that are:

Specific

Achievable

Time for implementation

Accountable

▫ The most important aspects of successful inspection

SO YOU’RE BEING INSPECTED

• Evidence based inspection

• If it hasn’t been documented it hasn’t been done

• Documentation is proof

DON’T PANIC!!

• Many components to the Pharmacovigilance System

▫ All very important contributors

▫ Many linkages across the organization / disciplines / functional lines

• Internal pharmacovigilance audits are integral to assure company compliance and are

a key success factor for Inspection Readiness

• Pharmacovigilance audit programs should be designed to deliver value by:

▫ Minimizing company risk

▫ Identifying opportunities for improvement

• Promote continuous improvement culture within organizations where:

▫ Audits are part of routine business

▫ Total Quality Management (TQM) tools and principles are utilized

• Sustain Inspection Readiness

▫ Maintain awareness of regulatory trends (e.g., Global / Local Regulations, Inspections,

etc.)

▫ Do everything in anticipation and preparation for an inspection

▫ Documentation is essential

Summary

• Do you have an inspection plan and contact list (and routinely test it)?

• Do you have procedures in place?

• Are they current?

• Are they retrievable?

• Do you report, process, and submit adverse events (from all potential sources)

within required timelines?

• Do you comply with company procedures and applicable regulations?

• Are your staff qualified and trained?

• Do you have quality systems in place to ensure data / process quality?

• Do you know where your documentation is maintained?

• Are active relationships in place with other relevant functional areas (e.g.,

Manufacturing, Clinical/Medical, Marketing, Sales, etc.)?

Are you Inspection Ready?

Terima KasihAtas Perhatiannya

Quality is embedded

in everything we do

Questions?