Quality Support
GxP Cellators: QMS Design & Technical Writing Services
A robust Quality Management System (QMS) forms the basis of GxP compliance. It is an integrated system of processes, procedures, and resources that ensures product quality, patient safety, and data integrity. At GxP Cellators, we design and document customized QMS frameworks to meet the specific regulatory and operational requirements of GLP, GMP, GCP, and GDP environments.
We go beyond generic templates to develop systems that align with your organizational culture and meet the stringent requirements of global regulatory agencies, including the FDA, EMA, Health Canada, WHO, and OECD.
Our Methodology
A Risk-Based, Lifecycle Approach
We use a structured, four-phase approach to QMS design to ensure the system is compliant, sustainable, and scalable.
Discovery & Process Mapping
QMS Architecture Design
Authoring & Development
Operational Implementation
Tailored QMS Design by Domain
While quality principles are universal, their application varies across laboratories, manufacturing, clinical trial sites, and the supply chain. Below is how we tailor our QMS design services for each GxP area:
GLP QMS Design (Non-Clinical Laboratory Studies)
In GLP, the focus is on the ability to reconstruct studies and data traceability. Our GLP QMS design ensures your non-clinical safety studies in pharmacology and toxicology are reliable and auditable.
- Study Director & QA Oversight: We develop procedures that define the authority and responsibilities of the Study Director and ensure the independence of the Quality Assurance Unit (QAU). This includes protocols for study plan approvals, raw data review, and final report audits.
- Raw Data & Archiving Systems: We implement systems for collecting, reviewing, and retaining raw data in both paper and electronic formats. We also design procedures for archiving specimens, raw data, and documentation in compliance with 21 CFR Part 58 and OECD.
- Multi-Site Study Management: For studies across multiple locations, we design QMS elements to ensure clear communication, defined responsibilities, and seamless data flow between the Test Facility and Test Sites.
- Equipment & Computerized Systems: We develop procedures for qualifying, calibrating, and maintaining laboratory equipment, and for validating computerized systems used to collect or process non-clinical data.
GMP QMS Design (Manufacturing & Quality Control)
In GMP, the focus is on product quality, patient safety, and manufacturing consistency. Our GMP QMS design is built around the core PQS (Pharmaceutical Quality System) elements outlined in ICH Q10.
- Document & Record Management: We develop procedural frameworks for document control, including SOPs, specifications, and master formulas. We establish systems for Good Documentation Practices (GDP) to ensure data integrity (ALCOA+).
- Deviation, CAPA, and Change Control: We design processes for managing deviations, conduct root cause analysis, implement Corrective and Preventive Actions (CAPA), and ensure changes are reviewed, approved, and validated before implementation.
- Validation Lifecycle Procedures: We author the core validation documents, including the Master Validation Plan (MVP), and supporting procedures for Process Validation, Cleaning Validation, and Analytical Method Validation across all product lifecycle stages (Stage 1, 2, and 3).
- Material Management & Traceability: We develop procedures that cover the entire material lifecycle, from supplier qualification and raw material testing to segregation of rejected materials and final product disposition, ensuring a full chain of custody.
- Product Quality Review (PQR): We establish processes for annual Product Quality Reviews to analyze quality trends and identify opportunities for continuous improvement.
GCP QMS Design (Clinical Trials)
In GCP, the focus is on subject safety, informed consent, and the credibility of clinical data. Our GCP QMS design ensures your trials are conducted ethically and generate reliable data.
- Essential Documents & TMF Management: We design frameworks for managing the Trial Master File (TMF) in compliance with ICH GCP E6(R3), ensuring it is complete, current, and covers all trial stages. We define procedures for managing essential documents such as the Investigator’s Brochure, protocols, and case report forms.
- IRB/IEC & Regulatory Agency Communications: We establish procedures for timely and compliant submission of protocols, amendments, and safety updates to Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), and regulatory authorities.
- Investigator & Site Selection/Monitoring: We develop SOPs for qualifying and selecting clinical investigators and sites. We also design monitoring plans to protect subjects’ rights and well-being and to ensure that trial data are accurate, complete, and verifiable against source documents.
- Safety Reporting & Pharmacovigilance: We design the interface between the clinical trial QMS and pharmacovigilance, establishing procedures for collecting, reviewing, and promptly reporting Serious Adverse Events (SAEs) and other safety information.
- Data Integrity & Computerized Systems: We develop procedures to ensure data integrity within Clinical Data Management Systems (CDMS) and to validate computerized systems used for capturing, processing, or analyzing clinical trial data.
GDP QMS Design (Warehousing & Distribution)
In GDP, the focus is on product integrity, temperature control, and security throughout the supply chain. Our GDP QMS design ensures pharmaceutical product quality is maintained during storage, transportation, and distribution, in compliance with EU GDP Guidelines, WHO GDP, and 21 CFR Part 203/205 (Prescription Drug Marketing Act).
- Temperature Excursion Management: We design procedures for managing temperature excursions during storage or transit, including immediate actions, stability assessments, and final disposition decisions in collaboration with qualified personnel.
- Qualification of Vehicles & Warehouses: We develop protocols for thermal mapping of warehouses and for qualifying refrigerated vehicles and shipping containers to ensure they consistently maintain required temperature ranges.
- Supplier & Transport Provider Qualification: We establish a risk-based QMS for auditing and qualifying third-party logistics providers, freight forwarders, and local distributors to ensure they meet GDP standards.
- Receipt, Storage, and Dispatch Procedures: We design procedures for inspecting incoming goods, maintaining proper storage conditions, and ensuring accurate, secure picking and dispatch to prevent mix-ups and damage.
- Recall & Returns Handling: We architect a procedural framework for efficiently managing product recalls (mock recalls) and processing returned goods, ensuring they are properly assessed, handled, and documented to prevent reintroduction of compromised products into the supply chain.
- Falsified Medicines & Product Security: We design QMS elements to address falsified medicines, including procedures for verifying product authenticity, securing the supply chain, and complying with serialization and traceability requirements (e.g., DSCSA in the US, FMD in Europe).
Our Technical Writing Expertise
Beyond designing the system, we build the content that brings it to life.
| Deliverable | Description & GxP Application |
| Site Master File (SMF) | A comprehensive document providing an overview of your facility’s GMP/GLP/GCP/GDP activities, structure, and quality systems, essential for regulatory inspections. |
| Master Validation Plan (MVP) | The roadmap for all validation activities, defining the approach, responsibilities, and schedule for process, cleaning, method, and computer system validation. |
| Standard Operating Procedures (SOPs) | Detailed step-by-step instructions for routine operations, from equipment use and cleaning to deviation handling, temperature monitoring, and data review, tailored to GLP, GMP, GCP, or GDP needs. |
| Policies & Quality Manuals | High-level documents that articulate management’s commitment to quality and establish the core principles of the QMS. |
| Protocols & Reports | Authoring of specific qualification/validation protocols (IQ/OQ/PQ) and the associated summary reports for equipment, facilities, utilities, vehicles, and processes. |
| Computer System Validation (CSV) Documents | Creation of the full validation package for computerized systems, including User Requirements Specifications (URS), Functional Risk Assessments, and Validation Summary Reports, adhering to 21 CFR Part 11 and GAMP 5 principles. |
| Witnessed / Remote QA Support | We can act as your remote quality team, providing real-time document review, batch record approval, and quality oversight for ongoing GMP, GLP, GCP, and GDP operations. |
Reach Out to Us!
For more details or to discuss your project requirements, please reach out to us. Your query will be handled with complete confidentiality, and we’ll ensure a prompt response.
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