Ppg Capabilities 2010
- 2. ProPharma Group is an industry leader providing ProPharma Group is built on the qualification, compliance and technical services to the foundation of developing long-term pharmaceutical, biotechnology and medical device relationships with clients. With this industries. We focus on enabling our customers to in mind, each project starts with a improve their operations, revitalize their facilities, and client kickoff meeting to correctly maintain quality leadership in a challenging and changing understand the project goals, timelines regulatory environment. We understand that our clients and limitations. Together we develop a are driven by aggressive timelines and are comfortable project plan and determine the critical working in such an environment while maintaining a strong factors for success. integrity and commitment to compliance. focus foundation expertise challenges Our compliance, validation and scientific professionals have expertise in biology, chemistry, engineering, information technology, We assemble our project teams manufacturing, project management, quality to best meet the needs of the assurance and quality control. The majority client. Each project manager has a of our staff’s experience comes from working combination of project management directly for operating companies, so they and project-related technical understand the unique concerns and challenges abilities to successfully lead a that are faced in a regulated environment. cross-functional team. The broad We attract talented people to our organization array of our technical expertise, by offering competitive benefit packages and our institutional knowledge base, creating an atmosphere that fosters a long term and the size of our consulting staff relationship between our colleagues and our ensures that each project has the clients. This long term perspective guides us day- best possible team. to-day to make the right decisions for both our clients and colleagues.
- 3. ram Manageme Prog nt Commissioning & Integrated Qualification Services Computer Cleaning Systems Validation Validation Project Management Process Analytical Compliance Technology (PAT) Services Consulting Process Laboratory Validation Services our services
- 4. Commissioning & Qualification Commissioning Services Qualification Services Commissioning is a well planned, documented and Validation Master Plans managed approach to the start-up and turnover of ProPharma Group regularly develops both site facilities, systems and equipment to the end-user Master Plans and project-specific Validation that results in an operational, safe, and functional Master Plans. Our plans guide the entire project system that meets established design requirements team toward the identified goals related to a and end-user quality expectations. facility that can be validated in compliance with Following current industry standards, such as ASTM all applicable regulations. E 2500 and those from ISPE, ProPharma Group Installation Qualifications can provide commissioning documents that verify ProPharma Group is proficient in writing and proper installation, operation at start-up, functional performing Installation Qualification protocols performance, and turnover of facilities, systems and to ensure that the equipment received is in good equipment. Our commissioning services include: condition, as designed, and properly installed in • Developing and executing commissioning plans the manufacturing environment. that support the overall project schedule Operational Qualifications • Developing commissioning documents (e.g. User We work together with our clients to develop and Requirement Specification, inspection forms, execute Operational Qualification protocols that Factory Acceptance Tests and Site ensure process equipment and ancillary systems Acceptance Tests) are capable of operating within established limits • Inspecting for physical completion and tolerances. • Vendor audits Performance Qualifications • Witnessing vendor commissioning activities ProPharma Group validation consultants • Managing the commissioning activities of have extensive experience with performance vendors, construction contractors, owners, and qualification of facility systems such as HVAC, contract resources. WFI, and process gas. • Executing commissioning activities for utility and process equipment systems in a manner that maximizes opportunities for leveraging with qualification activities.
- 5. Computer Systems Validation Our computer validation group can assist you with the complete life cycle of services associated with Computer System Validation. We offer the following services: Specification Development Commissioning, Qualification and We can assist you in the development of computer Validation Services system documentation in compliance with industry We can provide document development and standards as well as Good Automated Manufacturing execution services for computer hardware or Practices® (GAMP), including: software systems large or small. These • User Requirements Specifications (URS) services include: • Supplier/Vendor Audits • Factory Acceptance Testing (FAT) • Functional Specifications (FS) • Site Acceptance Testing (SAT) • Design Specifications (DS) • Commissioning Testing • Validation Master Planning (VMP) • Installation Qualification (IQ) • Software Development Life Cycle (SDLC) • Operational Qualification (OQ) • Performance Qualification (PQ) System Design Services • Requirements Traceability Our professionals are trained to provide a full System Type Expertise includes the following: gamut of design services ranging from the initial concept through full system integration. Available • Building, Facility, Utility Systems services include: • Infrastructure • IT Applications • Design Review • Laboratory Systems • Unit Testing • Process Control Systems • Integration Testing • Enterprise Level Systems • System Testing System Procurement and Installation Customer Support and Training Our organization can assist in solutions for any Our team is available to provide on-going system size system including: support and training services to supplement your company’s personnel resources including, but not • Project Management limited to: • Gap Assessment • Risk Assessment • Backup and Recovery • Vendor Leveraging • Data Archiving • Continuity Planning • Disaster Recovery • Periodic System Reviews • Surveillance Audits Good Automated Manufacturing Practices® (GAMP) is • ISO/QMS Reviews a Registered trademark of the International Society for • Best Practices Training Pharmaceutical Engineering. • SOP Development
- 6. Program Management • portfolio mangement • early & late stage drug/device development • technology transfer Program Management creates a centralized, high-level management platform to Assess, Plan and Execute complex programs that typically including multiple projects, each with timelines critical to getting your drug/device to market faster. ProPharma’s Program Management services provide solutions to your needs in: • Portfolio Management • Early and late stage drug/device development • Technology Transfer
- 7. Program Management Our value-added services are offered in response ProPharma Group brings to the table its multi- to challenges that companies routinely face disciplinary team that has a ready-to-use with moving a novel drug/device through the Toolbox of proven Project Management tools, development continuum, transferring technologies required strategic knowledge, hands-on industry between their manufacturing and partner sites, and regulatory experience, management and or outsourcing manufacturing to a Contract communication skills, and qualified Subject Matter Manufacturing Organization (CMO). Experts that contribute to the success of your Program success is contingent upon having clear program. By integrating performance measures, definitions and a concise strategy to provide a benchmarks and goals, organizational performance framework for building a Project Plan, including is monitored, measured, optimized and improved. developing a realistic schedule while understanding We can spearhead the due diligence process to the risks involved. The Program Team must be answer critical questions and help you plan for, and capable of filling key roles and providing support for reach a successful outcome, on time and within corporate processes in drug/device development budget. ProPharma Group’s Program Management and technology transfer. ProPharma Group’s Services drive the process; improving your Program Management Services drive the process organization’s performance, providing sustained forward, improving an organization’s performance momentum to meet the organization’s goals, and and ability to meet program goals. These services doing what is right for the business. include: • Portfolio and Risk Management S T R A T E G Y • Project Prioritization • Cross Project Planning and Scheduling PROGRAM MANAGEMENT PROCESS • Resource Planning • Budgeting • Communications Management Project Risk Goals • Quality Management Benefits Scope Changes (Time, Cost, Quality) • Development of the Program Management Organization (PMO) Initiate Plan Execute Close P R O J E C T P R O J E C T • Performance Management • Project Management Monitor & Control • Project Management Training • Program Lifecycle Management Project Management
- 8. Compliance & Quality Assurance ProPharma Group realizes that the Standards and Regulations identification of Quality Assurance (QA) ProPharma Group’s senior staff of quality, and Compliance problems is only part compliance and program/project management of the Compliance Puzzle; knowing professionals takes a proven, hands-on approach to what to do about them to mitigate your addressing our clients’ specific QA and Compliance situations to assure that their quality and regulatory compliance risk is the key! As a provider operations are in compliance with current industry of turn-key solutions, ProPharma Group standards and FDA/international regulations, such as: offers the following value-added QA and Food and Drug Administration (FDA) Compliance services: • Current Good Manufacturing Practice (GMP) Regulation Quality Assurance for Finished Pharmaceutical Products – 21 CFR Part 210/211 Our QA staff has extensive experience in regulated • Quality System Regulation (QSR) for Finished environments and brings this value to the table when Devices – 21 CFR Part 820 assisting our clients’ with their QA-related needs. • General Biological Products Standards – 21 CFR QA/QC Staff Augmentation Part 610 • Electronic Records; Electronic Signatures – 21 CFR • Policy, SOP and Batch Record Review, Part 11 Preparation and Optimization • Good Laboratory Practice (GLP) Regulation – 21 CFR • Quality System (QS) Development, Part 58 Assessment and Optimization • Guide to Inspections and Guidance For Industry: Miscellaneous • QS Auditing / Benchmarking International Regulatory Agencies • Corrective and Preventive Action (CAPA) International Conference on Harmonization (ICH) Planning and Execution • Validation of Analytical Procedures – ICH Q2 • Training – FDA, GMP QSR, Validation, , • GMP Guide for Active Pharmaceutical Operator, Safety, etc. Ingredients – ICH Q7 Compliance • Pharmaceutical Development - ICH Q8 • Quality Risk Management – ICH Q9 Our Compliance staff augments our clients’ internal • Pharmaceutical Quality System – ICH Q10 capabilities to prepare for, execute and address compliance-related observations and deficiencies, European Union Guide to Good Manufacturing Practices (Eudralex) thus mitigating our client’s regulatory risk. International Organization for Standardization (ISO) • Third-party GMP and GLP Compliance • Quality Management Systems – ISO 9000 and Auditing ISO 9001 • Mock FDA/International Regulatory Agency • Medical Devices – Quality Management Systems – Inspections and PAI Auditing Requirements for Regulatory Purposes – ISO 13485 • Due Diligence Compliance Inspections, Pharmacopeias Audits and Assistance United States, European, Japanese • FDA Action (483 Observations, Warning Industry Standards Letters, Consent Decrees) Remediation • Good Automated Manufacturing Practice (GAMP 5) • PIC/S, WHO, PDA, ISPE, ASTM Standards, Technical Reports and Guidance
- 9. Laboratory Services Our FDA registered laboratory provides validation related and routine testing support based on sound scientific methodologies and delivers the highest quality of service within compliance of worldwide GMP regulations and guidelines. External audits are welcomed and encouraged. Laboratory Services Total Organic Carbon (TOC) pH/Conductivity Advanced automated features and our high-capacity We use the USP the standard methodology for Autosampler combine for an unequalled level of conductivity testing of Water for Injection (WFI), efficiency, allowing us to promptly provide accurate purified water and clean steam. results. The TOC methodology can be validated per USP and ICH Q2 guidance to demonstrate that it is Growth Promotion suitable for use with your compounds. We are capable of performing growth promotion testing on an extensive array of biological media types. The Endotoxin (LAL) duration of incubation, temperature and evaluated LAL is a highly sensitive and specific assay used organism species can be customized according to to screen water, clean steam, raw materials and your specific growth promotion requirements. finished product for the presence of endotoxin. To produce quantitative endotoxin values, we use Microbial Limit Testing the Kinetic Turbidimetric Method. Our integrated We provide method development, method validation software and instrumentation make it possible and routine testing services to quantify and monitor for us to provide fast, accurate results for every for objectionable microbiological contaminants. sample tested. Applications Total Microbial Count (Bioburden) • Water systems qualification Testing for bioburden in water systems, raw • Environmental monitoring materials and final products is necessary to • Cleaning validation determine compliance to compendial requirements. • Disinfectant qualification We test for bioburden per the USP pour plate and • Raw material and finished product filtration methods. • Microbial media growth promotion • Water system assessment Microbial Identification • Routine and investigational utility and We are able to identify environmental isolates, environmental testing pathogens, spoilage organisms, control strains and media fill contaminants.
- 10. Process Validation Process validation is defined as establishing We can review your development reports to assist documented evidence that a specific process in the determination of critical process parameters will reliably and consistently produce a product and quality attributes, and use this review to that meets its predetermined specifications and develop scientifically justified validation plans, which quality attributes. Processes could encompass demonstrate consistency and reliability in processing. manufacturing, filling, sterilization, and packaging We can also assist you in developing statistically within the FDA regulated pharmaceutical, justified in-process and finished product sampling biotechnology, API and medical device industries. strategies. Knowledge of the critical processing steps, quality attributes and sampling strategies allows ProPharma Group employees have experience our process validation engineers to challenge the validating processes in all aspects of the FDA robustness of the process during the development regulated industries. and execution of the validation studies. Process Analytical Technology (PAT) Consulting ProPharma Group has combined its extensive Develop: By working together with you, we select and background in process validation and control develop the solutions identified in the action plan. systems to offer a complete PAT solution to clients. Solutions could include process instrumentation, Dating back to 1998, ProPharma Group has helped analytical software, quality procedures and multi- clients bring their pharmaceutical manufacturing variate analysis. processes online to provide valuable information as Implement: We’ll help you install, validate and go live production occurs, spanning everything from raw with each solution. We team with your resources to materials to batch release. perform such tasks as commissioning, qualification ProPharma Group has developed a four phased and training. approach to addressing the PAT Initiative, based Monitor: We advise you on how to best monitor your on the key principles defined by the FDA: implemented PAT solutions to ensure you are getting Investigate, Develop, Implement and Monitor. We the results you need. We also help you decide when see these four phases as cyclical as true compliance to return to the investigation phase and continue on with the PAT Initiative is attained. the four phase cycle. Investigate: We begin with an investigation into your ProPharma Group has assembled a team of consultants, current processes and systems in place to control, partners and specialized experts to work together with monitor and ensure quality of these processes. We you to understand and implement Process Analytical then recommend an action plan. Technology solutions.
- 11. Cleaning Validation The prevention of cross contamination is an ProPharma Group has the expertise to guide you essential component of any GMP program and is through the cleaning validation process. necessary to ensure the safety of drugs, biologics We are experienced at developing and executing and medical devices used in human or veterinary validation master plans and protocols abreast with applications. A major source of contamination risk current industry standards. We provide a hands-on to these products is in the form of carryover of group of professionals that can guide you through compounds and cleaning agent residues from the the details of establishing a cleaning master plan, previous manufactured product or cleaning process. setting residue acceptance criteria, preparing Properly designed and executed cleaning validation a comprehensive sampling plan and validating studies ensure that the process removes product and utilizing appropriate analytical methods with and cleaning agent residues from product contact sufficient sensitivity for those unique processes surfaces to an acceptable limit. and equipment. Integrated Services Our Integrated Services provide you peace of mind by having us manage all of your current challenges to deliver projects in compliance, on time, and in budget. These services include: • Automation • Quality Audits • Compliance Consulting • Standard Operating Procedures (SOPs) • HEPA Filter Certification • Software Development • High Purity System Piping QA/QC • Test and Balance • Information Technology Solutions • Training • Project Management For a complete list of our Integrated Services, refer to our website at W W W. P R O P H A R M A G R O U P. C O M
- 12. W W W . P R O P H A R M A G R O U P. C O M (888) 242-0559