Pharmaceutical Industry
An early stage biotech company does not need the same Quality Management System as a Phase III sponsor or a Marketing Authorisation Holder. But the foundations established early can determine how easily the Quality system can scale as responsibilities, outsourced activities and regulatory requirements increase.
QUALITY THROUGHOUT THE LIFECYCLE
Quality for pharmaceutical companies.
Quality requirements evolve as a pharmaceutical product moves from early development through clinical trials, marketing authorisation and commercial supply. OZQA helps pharmaceutical and biotechnology organisations understand, establish and develop the Quality systems, processes and documentation needed at each stage of the pharmaceutical lifecycle.
Pharmaceuticals
Moving from preclinical development into your first clinical trial represents one of the most significant changes in quality requirements for a biotech company. The OZQA pharmaceutical QMS framework is modular, allowing you to build on the same quality foundation as your development programme progresses.
Bring together the documentation needed to support product safety, ingredients, manufacturing, claims and regulatory compliance. Ensure regulatory, product and Quality documentation is aligned before commercial distribution begins.
FROM DEVELOPMENT TO MARKET
One pharmaceutical lifecycle. Changing quality responsibilities.
The Quality Management System required for a pharmaceutical organisation depends on what the company does, what it outsources and where the product is in development.
Many virtual and emerging biotech companies outsource laboratory activities, clinical operations, manufacturing, testing, storage and distribution. Outsourcing these activities can reduce the need for internal operational infrastructure, but it does not eliminate the organisation's responsibility for appropriate oversight. As development progresses, the QMS therefore needs to evolve alongside the organisation.
BUILD THE QUALITY FOUNDATION
Pre-clinical quality management.
During early pharmaceutical and biotech development, organisations are often small, highly specialised and dependent on external laboratories, CROs, manufacturers and other service providers. At this stage, the goal should not necessarily be to build a large pharmaceutical QMS designed for commercial operations. Instead, the Quality system should be proportionate to the organisation's activities, risks and development plans.
FROM RESEARCH TO CLINICAL TRAILS
Quality management for clinical trial sponsors.
Moving into clinical development introduces additional sponsor responsibilities and a much greater need for documented Quality oversight. Under ICH E6(R3), sponsors are expected to implement an appropriate system for managing quality throughout the trial process using a proportionate, risk based approach. Sponsor oversight remains important even when trial activities are transferred to CROs or other service providers. For many emerging biotech companies, this is therefore the point where the Quality system needs to expand significantly.
Phase I & II
Early clinical development moves the organisation into a regulated environment involving clinical sites, investigators, CROs, safety reporting, trial documentation and regulatory interactions. The QMS should support the sponsor in maintaining oversight of these activities and provide documented processes for managing issues that may affect participant safety, data reliability or regulatory compliance.
Phase III
By Phase III, clinical programmes are typically larger and operationally more complex. There may be multiple countries, CROs, laboratories, manufacturing partners, clinical supply chains, vendors and larger volumes of clinical and Quality data. The Quality system therefore needs to scale beyond the foundation established during earlier clinical phases.
PREPARING FOR COMMERCIAL RESPONSIBILITIES
From clinical development to marketing authorisation.
The transition from clinical development to marketing authorisation changes the Quality landscape again. The organisation is no longer only managing development and clinical sponsor responsibilities. It must prepare for the obligations associated with becoming a Marketing Authorisation Holder and placing an authorised medicinal product on the market.
The exact QMS depends heavily on the company's operating model. A virtual MAH outsourcing manufacturing and logistics requires a different internal Quality structure from a pharmaceutical manufacturer operating its own GMP facility. For this reason, OZQA separates post market Quality into three important operational areas:
Marketing Authorisation Holder
The MAH retains responsibility for ensuring that its own activities and relevant outsourced activities comply with applicable EU requirements. EMA identifies GCP, GLP, GMP, GDP and GVP among the compliance areas relevant to marketing authorisation holders.
For companies using outsourced manufacturing, the QMS therefore needs appropriate processes for governance, supplier and partner oversight, Quality Agreements, changes, complaints, recalls, deviations and CAPA, documentation and ongoing Quality oversight.
In-House Pharmacovigilance
A Marketing Authorisation Holder must operate a pharmacovigilance system to fulfil its pharmacovigilance obligations. In the EU, this includes an appropriately qualified EU QPPV and a Pharmacovigilance System Master File describing the system and relevant outsourced arrangements.
A PV Quality system needs to support activities such as safety information management, signal management, aggregate reporting, risk management, responsibilities, training, audits, deviations and CAPA, vendor oversight and maintenance of the PSMF, as applicable to the organisation.
Wholesale Distribution & GDP
Companies involved in wholesale distribution of medicinal products have additional responsibilities relating to Good Distribution Practice. The Quality system needs to reflect the organisation's actual distribution model, including the use of outsourced warehouses, logistics providers and other partners where applicable.
Processes may cover supplier and customer qualification, storage and transportation, complaints, returns, recalls, deviations, CAPA, change control, documentation and oversight of outsourced distribution activities.
QUALITY OVERSIGHT ACROSS YOUR PARTNER NETWORK
Managing quality in virtual pharmaceutical companies.
Modern pharmaceutical and biotech companies can operate with surprisingly little infrastructure in house. Development, clinical trials, manufacturing, testing, storage, distribution and pharmacovigilance can all involve external specialists. This makes supplier and partner oversight a central part of the pharmaceutical QMS.
Quality Agreements, qualification, risk assessment, audits, performance monitoring, deviations, CAPAs, changes and documented oversight help establish how responsibilities are controlled across the external network.
The principle is important: Activities can be outsourced. Oversight cannot simply disappear!
GXP THROUGHOUT THE LIFECYCLE
Pharmaceutical quality regulations.
There is no single regulation that defines one identical QMS for every pharmaceutical company. Applicable requirements depend on the company's products, activities, development stage, geography and responsibilities.
 GMP |  GVP |
|---|---|
 GCP |  GDP |
START WHERE YOU ARE
Three ways to build a better QMS.
The OZQA QMS provides ready-to-use quality documents, complete QMS packages designed specifically for regulated companies, and expert quality support. Whether you're starting from scratch, improving an existing system or preparing for your next milestone, we help you focus on what actually matters.
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BUILT TO WORK TOGETHER
Not just individual templates.
Our products are developed as parts of connected Quality processes. Procedures define how the process works and forms capture the required evidence, and related processes connect one document with the wider QMS.
FROM PROCEDURES TO WORKFLOWS
Pharmaceutical QMS digitalisation.
The pharmaceutical QMS may be paper based, document based or implemented within a digital Quality Management System. The technology itself does not determine compliance.
The underlying processes, responsibilities, controls, records and oversight need to be appropriate for their intended use. For computerised systems used in clinical trials, EMA highlights requirements around fitness for purpose, security, audit trails and proportionate risk based validation. Digitalisation can nevertheless make a well designed QMS easier to operate by connecting activities
FREQUENTLLY ASKED QUESTIONS
FAQ
Pharmaceutical Quality Management can look very different depending on your organisation, development stage and regulatory responsibilities. Here, we answer some of the most common questions about pharmaceutical QMS requirements, clinical development, GxP compliance, outsourcing and Quality Management from preclinical development through to commercialisation.