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 Inspection Plan

PLANNING
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) The inspection dates are confirmed with the MAH

MAH supplies the SPS

INSPECTION

Main inspection of the MAH takes place

REPORTING

After the inspection, a report of the findings is issued to the MAH

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

Once CAPA acceptable, an inspection closing letter is issued*

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 Terdaftar

2.1 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 ?
Types of PhV Inspection
Routine Inspection For cause inspection Risk based Inspection

Type of PhV System Audits

Global PhV systems/processes Company Affiliates (i.e.,

Country Office, Marketing

Company) Marketing (Licensing) Partners

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

Follow-up

Conduct

CAPA

Reporting

Preparing for Inspections

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

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

Conduct of 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

During the Inspection

Relax, dont panic!
Listen carefully to the Inspectors 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

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 Risk Management Local SDEAs SOPs Data management Archiving Quality Assurance Regulatory affairs Many examples of evidence

staffs
PSUR
ICSRs process Case files for ICSRs

Clinical Trial
List of products

e.g. you said you do this, show me an example

Close out Meeting

Ensure appropriate company personnel are present for

close out meeting

Clarify misunderstandings Confirm reporting and response procedures Communicate corrective actions implemented during

the inspection

Reporting
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

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 YOURE BEING INSPECTED

Evidence based inspection If it hasnt been documented it hasnt been done Documentation is proof

DONT PANIC!!

Summary
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

Are you Inspection Ready?

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.)?

Quality is embedded in everything we do

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Questions?