CHEMPHARMBEYOND COMPLIANCE

Chuan YaoPrincipal Consultant

www.chempharm.asia

Presentation Content

• Introduce ChemPharm• Our Expertise and Services• International Standards• Examples of ChemPharm’s Projects• Trusted Customers

ChemPharmChemPharm is a professional full service consulting firm that has extensive practical expertise of supporting Pharmaceutical, Biotechnology, Medical Devices, Traditional Chinese Medicine (TCM) and Cosmetic industries. We stay current with international regulatory changes to maintain a truly upfront global perspective. ChemPharm is able to provide specialist expertise across all areas including: QA, QC, Production, Logistics, Product Development and Regulatory Affairs.

Our Locations

Our Vision

To be a partnerTo be ethical in everything we doSharing trust, strategy,

information, vision and benefits

Our Mission

To provide expert services and support to the Pharmaceutical, Biotechnology, Medical Devices, Traditional Chinese Medicine (TCM) and Cosmetic industries

To be recognized as a major stakeholder in the regional market

Critical Success Factors

• Quality people, processes and services• Cohesive team approach• Aligned strategies• Performance measurability• Clear understanding of what must be done

Competitive advantage

• Consulting group & associates

• International coverage

• All consultants industry experienced - broad range

• Consultants have direct FDA experience in

management

• Significant technical resource library

• Client loyalty and excellent industry reputation

• Combined training and consulting crossover

We Are Committed

We are committed to doing business in an ethical and socially responsible manner.

We strive to develop long-term relationships with clients, based on the highest levels of integrity, professionalism and trust.

Our Services

Integrated Business Solutions

ChemPharm ServicesCompliance Consulting and Risk Based ServicesGap analysis to all international regulatory standardsQuality Management Systems (QMS) development, implementation and upgradesGMP, GDP, GLP, and GCP compliance upgradesGMP/QSR corporate policies and standard operating proceduresTechnology transfer oversightCAPAs and Deviations programs implementation and improvementIndependent third-party QSR, GMP, GCP, GLP, and ISO auditMock FDA auditSupplier due diligence auditGMP, GDP or GLP licensing supportIntegration of risk management into corporate quality assurance systemsDevelopment of appropriate quality risk management toolsGap analysis to identify and mitigate compliance riskImplementation of risk mitigation activities483, Warning Letter Response StrategyAudit Nonconformance Response Strategy

ChemPharm Services

Validation strategy and program development

Validation master planning

Validation documentation (plans, protocols, reports writing)

Process validation

Equipment qualification

Facility and utility validation

Software/21 CFR Part 11/computer system validation

Conducting computer system GAMP compliance gap analysis

Analytical method validation

Cleaning validation

Validation Services

ChemPharm Services

Product development strategy

Dossier compilation as per ASEAN Common Technical Dossier (ACTD) Guidelines

Dossier compilation in Common Technical Dossier (CTD) format

Expert Report for Quality

Regulatory submissions: United States, EU, China, Australia, New Zealand and ASEAN countries

Product Licence Maintenance

Regulatory CMC Strategy and Dossier Preparation

Drug Master File (DMF) compilation for open and closed parts

510(k) Administrative Review and Submission

FDA and notified-body liaison

Authorized representation

Regulatory Affairs Services

ChemPharm Services

Training Services

Customized training programs to meet clients' requirements

Training available in GMP/QSR/GDP/GLP(~ 10 modularised subjects)

FDA inspection readiness

Validation

Risk Management

How to avoid a warning letter

Conduct of clinical trials

At our site as your remote support team At your CMO's site as your "man in the plant" At your site as an integrated part of your current team

Flexible Resourcing Solutions

ChemPharm Services

Our Highlights

• Extensive in-depth working knowledge and experience

• Wide understanding and knowledge of international regulations, codes and standards

• We stay current with international updates and regulatory standards

• Value all partnerships and are committed to doing business in an ethical, sociably acceptable manner

• Strive to develop and maintain excellent relationships with clients

• Combined training and consulting crossover - integrated support

ChemPharm’s Business Statement

Beyond Compliance

We achieve this as ChemPharm consultants have extensive in-depth working knowledge and experience in International Regulations, Codes and Standards, including the major GMP regulations, codes and standards.

International Standards

• PIC/S Part 1, Part 2 and Annexes

• EU/UK EMEA, MHRA Eudralex Volume 4 (Orange Book)

• CFDA

• US FDA 21CFR Parts 210 and 211,

• US FDA 21 CFR Part 11 (Computers)

• US FDA 21 CFR Part 820 (Devices)

• WHO Guide to GMP 2007

• ASEAN Code of GMP

• ICH Q1, Q2, Q7, Q9, Q10

• ISO 17025, 14971, 13485,

• Industry Guidance Documents(PDA, GAMP, ISPE)

• Global Pharma Corporations

• Biotechnology groups

• Companies setting up for big Pharma partnering

• Medical Device manufacturers- market transition

• National companies migrating product to FDA

• Computerised solutions and compliance

• Regulatory submissions

Examples of Projects

Examples of Projects

• Qualification of contractors and vendors

• Manufacturing process development and process validation

• Development of stability and Quality Control test programs

• Regulatory strategy and dossier preparation

• Responding to regulatory agencies

• Assisting National Companies with Regulatory submissions

Examples of Projects

• Quality Assurance over New Facilities

• New Facility Projects: Design, Procurement, Installation, Commissioning, Validation (including Process Validation), QMS, Training

• Accreditation or registration of facilities to PIC/S, FDA, ISO 13485

• Validation including Computer Systems Validation

• Development of a compliant Quality Management System eg PIC/S, FDA, EU, ISO 13485

• Gap Analysis, remediation planning and implementation for QMS, Computer Systems, Validation, Product Development

• Training of staff

• Project Planning

• Risk Assessments

ChemPharm Types of Clients

• Multinational Pharmaceutical and Medical Device Corporations

• National Pharmaceutical Companies

• National Medical Device Manufacturers

• Medical Device, Pharmaceutical and Biological Start-up Companies (GLP …. Phase I/II)

• Contract Manufacturers in Pharmaceutical, Medical Device and Biological Industries

• Chinese Herbal Medicine / Complimentary Medicine Companies

• Suppliers to these regulated industries

• Clinical Trial Facilities

Examples of some ChemPharm Clients