Quality Assurance

Our Pharmaceutical Quality Assurance consulting team have extensive expertise and knowledge ensuring adherence to cGLP, cGCP, cGMP, cGDP and ISO requirements so that you can manufacture and distribute your products safe in the knowledge that your products are of the highest quality and you are fully compliant with the regulations and legal standards.

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Total compliance is our watchword and many companies trust our pharmaceutical quality assurance services to:

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• Provide strategic advice on the types of manufacturing and distribution licences required to support the client’s commercial objectives

• Set up/manage their Quality Management System (QMS)

• Guide them through the process of obtaining their own Broker’s Licence, Wholesale Dealer’s Authorisation, Manufacturer’s Licence and Manufacturer’s Specials Licence

• Conduct audits of 3rd parties and pre-site inspection.

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For more information on our expert quality assurance services, get in touch with our knowledgeable team.

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Our Services

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Audits

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• Due diligence (Quality) of product and facility acquisitions

• Manufacturers of API, Intermediates and Excipients (APIC Certified Auditors)

• Distributors of API

• Contract Laboratories (GMP/GLP/ISO)

• Manufacturers of Final Drug Forms

• Distributors and Logistic Providers (GDP)

• Software Suppliers (PDA and Tick-it Certified Auditors)

• Contract Manufacturing Organisation

• Laboratory Testing

• Clinical & Pre-Clinic Audits

• Investigational Site Audit

• Sterilisation Facilities

• Storage and Distribution

• Suppliers of Equipment & Utilities

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Data Integrity Assurance

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• Data Integrity Policy

• Computer System Validation Strategy

• Best Practices for Cost Saving & Quality of 21 CFR Part 11 Compliance Strategy

• Validation Templates and System Specific Packages

• 21 CFR Part 11 & EU GMP Annex 11 Assessments

• Risk-prioritized &Turnkey Remediation Projects

• 21 CFR Part 11 Inspection Readiness Projects

• Data Integrity Historical Verification

• Continuous Monitoring Procedures for Data Integrity

• Audit Trail Review Methodologies

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Compliance

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• Compliance Strategies

• Continuous Improvement and Performance Metrics Implementation

• Risk Management Implementation

• Quality System Implementation (Corporate Policies and Local SOPs)

• Quality Structures (QC, QA, RA) Assessments for Skills and Staffing

• Inspection Readiness Master Plans (FDA, EU, ANVISA, CFDA, PMDA, TGA etc)

• Mock Inspections and Assistance During Inspections/Post-Inspection

• Supplier Management and Monitoring Strategies

• Training Systems Implementation / Mentoring / Coaching

• Retrospective Review of Production Data

• Training in GMP/GDP Compliance and Topical Matters

• Support in critical event management (complaints, deviations, sterility failures, recalls)

• Change Management Support

• CAPA System Implementation

• Annual Product Review support

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Quality 

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A robust quality system is integral to ongoing regulatory compliance and smooth inspections and audits. Qualitas is fully equipped to serve as an outsourced quality department, creating and implementing a customized quality system for our clients.

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Our extensive experience in quality systems includes the following:

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• Quality Management System Development & Implementation: We identify necessary procedures based on client and product-specific needs and develop and deploy customized standard operating procedures (SOPs).

• Design Control: We offer design control solutions from concept through design transfer. Our Consultants guide our clients through each phase of the process to establish and maintain design history files (DHF).

• Risk Management: A risk management strategy is essential when developing and manufacturing medical devices and a well-cultivated risk plan must be integrated throughout the product lifecycle.  Qualitas has developed solutions to address the GMP requirements for risk planning, risk management, and to reduce risk as far as possible for each client. We work with each client’s unique needs to customize traditional analysis methods such as fault tree analysis (FTA) and failure mode effect criticality analysis (FMECA) for the situation.

• Post Production Services

  • Nonconforming Material Reports

  • Complaint Handling

  • Corrective Actions and Preventive Actions (CAPA)

  • Management Review

  • Health Hazard Evaluations (HHE)

  • Warning Letter Responses

• Design Verification and Validation: Our Consultants determine test requirements, select and manage appropriate laboratory service providers, generate protocols and reports, analyze data, and resolve failures.

• Project Management: We assign a project manager as the single point of contact for each project. Our project managers and consultants have the skills and experience to manage both long and complex projects as well as projects of shorter duration at whatever level the client requests. We utilize a team-based approach to select the most appropriate expert for each project deliverable, resulting in added value for our clients.

• Unique Device Identification (UDI): Our consultants develop an implementation strategy customized for each client’s products and supply chain structure. This includes obtaining UDIs, creating and validating UDI labels/direct part marking, and managing the Global UDI Database (GUDID) submission to the FDA.

• Quality System Training: Training is matched to each client’s needs for integration of quality-related practices into their organization.

• Virtual Document Control: We develop organized and functional document control and record management systems for effective and traceable implementation of quality systems.

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* If you do not see your specific quality need listed above, please contact us for a more detailed list of services

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Regulatory Affairs

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With the pharmaceutical and biotechnological environment continually changing, clients depend on our experienced consultants to provide crucial guidance to avoid costly mistakes such as data deficiencies or omissions. Failure to comply with regulatory requirements can trigger recalls or delay the approvals of new products, resulting in a substantial loss of revenue for the company.

Our experienced consultants apply their knowledge and expertise of pharmaceutical regulations to help companies navigate the ever-changing regulatory environment.  We provide support throughout the entire product lifecycle, such as defining regulatory pathways, managing regulatory submissions, and assessing the regulatory impact of labeling and design changes.

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