Future Challenges and

Objectives for PDA in AsiaPac

Connecting People, Science and
Regulation®
 Richard M. Johnson
President & CEO
Parenteral Drug Association

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About PDA
• The Parenteral Drug Association (PDA) is the leading
global provider of science, technology, and regulatory
information.
• The PDA creates awareness and understanding of
important issues facing the pharmaceutical and
biopharmaceutical community and delivers high-quality,
relevant education to the industry.
• Since its founding in 1946 as a nonprofit organization,
PDA has been committed to developing scientifically
sound, practical technical information and expertise to
advance pharmaceutical/ biopharmaceutical
manufacturing science and regulation, so members can
better serve patients.

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2020 – A Year of Challenges
• In this period of global disruption, let’s remember all those
who have been impacted by the pandemic and the
economic effects.
• Let’s also thank all those who have stepped up:
– First Responders, healthcare workers, and our
community which is continuing to provide critical
medicines, continuity of safe, effective supplies, and
our hope for a future without COVID.

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 PDA’s Model: Advocacy & Outreach
→ World leading conferences
→ Renowned training
→ Publications
→ Chapters, Interest Groups, and
Sharing
Knowledge platforms for exchange

→ Joint Conferences (FDA,

EMA) → Development of Technical
→ Training Partnerships Reports, Research,
Engagement
(PIC/S, ICH) with Standards
→ Regulatory Comments Regulators → Regulatory Participation
→ Regulators: members, → Collaborations (R3N, PQRI,
participants and AAMI, PMF, BPOG, ASTM,
reviewers SCB, IPEC, ISPE, et al)
Driving Scientific
Consensus

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 Key Actions by PDA
• COVID Task Force
– Developing guidance on manufacturing, supply chain,
control related to pandemic
• Manufacturing Science and Operations Program
– Focusing efforts on improving manufacturing
• Combination Products Steering Committee
– Developing focus on combination products
• Remote Audits and Inspections Task Force
– Developing best practices

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 Asia Pacific Focus

• Currently 18% of PDA global membership

• Significant region for pharmaceutical manufacturing, with growing

importance in biologics manufacturing

• Need expanded participation from members in Asia Pacific

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 Global Conferences
• Bringing key global
conferences to you
– Virtual
participation
possibilities
– Key sessions
timed to be
compatible with
AP Time Zone
– Conference
presentations
available on
demand

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Technical Publications
Selection of Recent Technical
Publications
 TR 84 Integrating Data Integrity Requirements into
Manufacturing & Packaging Operations PDA Points to Consider
 TR 83 Virus Contamination in Biomanufacturing: Risk
 Points to Consider for the Aseptic Processing of Sterile
Mitigation, Preparedness, and Response
Pharmaceutical Products in Isolators
 Points to Consider for Sensitivity to Oxidation by Peroxide
 TR 82 Low Endotoxin Recovery  Points to Consider for Risks Associated with Sterilizing
Grade Filters and Sterilizing Filtration
 TR 81 Cell-Based Therapy Control Strategy  Points to Consider for Implementation of Pre-Use Post-
Sterilization Integrity Testing (PUPSIT)

 TR 80 Data Integrity Management System for

Pharmaceutical Laboratories

 PDA Reporte Tecnico No. 13

(Revisado) Fundamentos de un  PDA Research: 2021 Post-Approval Change Issues and
Programa de Monitoreo Ambiental en Impacts Survey
Español (versión digital de un solo  PDA Research: 2019 Technology Transfer Industry
usuario) Survey
 PDA Research: 2019 Sterile Lyophilized Drug Product
Loading Survey
 PDA Research: 2019 PDA Traceability of Primary
Packaging Survey

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 Selected Active Areas
Quality &
Sterile Manufacturing
Supply Chain Biotechnology
Manufacturing Science
Management

QRM for Aseptic (Std.) Purchasing Controls (Std) Cryopreservation (Std)

Big Data in Mfg. (TR)

PUPSIT Research Data Integrity (multiple TRs) Cell & Gene Therapy

Operational Metrics (TR)

Phage Retention Nomenclature

Zero Defects for Visible Particles
QRM for Excipients (TR) Rating for Small and Large Virus
(TR)
Retentive Filters Std)

Cleaning Validation (TR)

Virus Contamination in
Post Approval Change Management
PFS Design Control Annex (TR) Biomanufacturing: Risk Mitigation,
Plans (TR)
Preparedness and Response (TR)

Phase-Appropriate GMPs -- Tech Transfer (TR)

Process Validation for Protein
Isolator Technology (TR) Technology Controls for Pilot Plants
Manufacturing (TR)
(TR)

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PDA Contact Info:

Global HQ
PDA Member Relations
4350 East West Hwy. Suite 600, Bethesda, MD 20814 USA
info@pda.org or +1-301-656-5900

PDA Asia Pacific

20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914
Tel: +65 64965504

PDA Europe
Am Borsigturm 60
13507 - Berlin, Germany
Tel: +49 30 436 55 08-0 or -10

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