Case Study: QMS Gap Assessment and Integration
This case study describes the approach, execution, and outcomes of a Quality Management System (QMS) gap assessment and integration project conducted for an Australian sponsor, importer, and wholesaler of non-scheduled prescription radiopharmaceutical products. These products included medicines supplied under Section 19A approval pathways and the Special Access Scheme (SAS). The company engaged Quality Systems Now (QSN) to evaluate its existing QMS against the requirements of PIC/S PE 009, including Annex 3, and to implement corrective actions necessary to meet minimum Therapeutic Goods Administration (TGA) expectations for regulated radiopharmaceutical handling activities. The project also included the redevelopment of controlled QMS documentation, subject-matter-expert engagement, and training on updated processes.
This article outlines the scientific and regulatory rationale behind the methodology used, the main findings from the assessment, the document remediation phase, and the implementation of training to ensure functional and sustainable compliance.
Project Background and Regulatory Context
The organisation operated under multiple regulatory responsibilities: sponsor obligations, importer obligations, and wholesale supply obligations for radiopharmaceutical products. Despite the products being non-scheduled, they fall within the scope of therapeutic goods legislation, including requirements for good distribution practice (GDP) and good manufacturing practice (GMP) where relevant to product quality, safety, identity, and traceability. Radiopharmaceuticals introduce additional complexity due to their time-sensitive nature, specialised manufacturing origins, radiation safety requirements, and handling constraints.
PIC/S PE 009 provides the internationally harmonised GMP guide adopted by the TGA as the manufacturing quality standard for medicines. Annex 3 of PIC/S PE 009 includes specific expectations for radiopharmaceuticals, covering production controls, material management, contamination risk management, aseptic-related principles, and radiological safety considerations. For non-manufacturing entities such as sponsors and importers, not all sections of the code are directly applicable; however, TGA expects that essential quality functions—such as documentation, deviation management, product quality reviews, supplier qualification, and training—demonstrate alignment with relevant portions of the code.
The company requested QSN to determine whether its existing QMS met the minimum TGA requirements and to provide practical, implementable solutions for compliance.
Methodology for the QMS Gap Assessment
QSN initiated the project with a structured gap assessment. The assessment compared the client’s QMS documents, procedures, and records against applicable sections of PIC/S PE 009 and Annex 3. The approach followed a systematic review of each quality system element, including:
Quality governance and document control
Supplier qualification and oversight
Product release and distribution controls
Complaint, deviation, and CAPA management
Change control processes
Training and competency management
Recall and incident management
Validation requirements where applicable to radiopharmaceutical handling
Records management and traceability expectations
The assessment also considered the company’s operational scope. As a sponsor and importer, the organisation did not perform manufacturing, batch testing, or batch certification activities. However, the TGA still expects documented evidence that the sponsor maintains oversight of the manufacturers, understands the relevant GMP requirements, and manages quality risks associated with product supply.
QSN conducted interviews with subject-matter experts, reviewed historical quality events, and examined the interaction between operational practices and existing procedures. This ensured that the gap analysis reflected both documentation compliance and practical implementation.
Key Findings from the Gap Analysis
The assessment identified several areas where the QMS partially aligned with PIC/S requirements and other areas where documentation or processes were missing, outdated, or insufficiently detailed. The key findings included:
Document Control Structure – The existing QMS had a partially developed document hierarchy but lacked a consistent template, version control methodology, and definition of responsibility for document lifecycle management.
Supplier Qualification – While supplier files existed, the process did not include a structured risk-based assessment aligned with PIC/S expectations. Critical import suppliers, including radiopharmaceutical manufacturers, required more formal qualification records.
Deviation and CAPA Processes – Deviation reporting was informal and not consistently captured in a controlled format. Corrective and preventive actions were undertaken but not recorded through a structured CAPA system.
Complaint and Recall Procedures – The organisation had established complaint handling processes; however, the linkage to recall assessment and regulatory reporting obligations required clarification and updates.
Training Records – Training was performed as necessary but lacked a competency-based framework, documented training matrices, and traceable assessments of understanding.
Integration of Annex 3 Requirements – Some radiation-related safety considerations existed under workplace health and safety documentation, but they were not sufficiently integrated into the quality system as required for radiopharmaceutical handling oversight.
These gaps provided the basis for the remediation plan.
QMS Document Creation and Integration Activities
Following the assessment, QSN created or updated approximately 55 QMS documents. Each document was developed using a scientific and regulatory rationale aligned with PIC/S terminology, ensuring clarity, traceability, and consistency. Document types included procedures, templates, registers, and controlled forms.
The documents addressed all essential quality elements relevant to the company’s activities. Examples of document categories updated or newly created included:
Document control and quality governance procedures
Supplier qualification and monitoring processes
Product release and importation procedures
Deviation, CAPA, and change control procedures
Training and competency procedures
Recall and complaint management procedures
Distribution and storage control documents
Risk management procedures reflecting radiopharmaceutical-specific considerations
Procedures integrating Annex 3 expectations appropriate to a non-manufacturing entity
QSN ensured that each document was integrated into the existing QMS in a manner that preserved operational continuity. A cross-reference matrix was created to map each QMS document to relevant sections of PIC/S PE 009 and Annex 3, providing clear evidence for auditors and inspectors.
Engagement with Subject-Matter Experts
Collaboration with internal SMEs was essential to ensure scientific accuracy and operational relevance. QSN facilitated workshops and document review cycles involving logistics personnel, radiation-safety officers, regulatory affairs staff, and quality personnel. This ensured that each document reflected real-world practices while meeting TGA expectations.
SME engagement also helped validate product-specific considerations, such as half-life constraints, cold-chain requirements, and manufacturer-specific documentation obligations. Integrating these details into the QMS helped reduce compliance risk and improve operational consistency.
Training and Implementation
QSN delivered training sessions covering all updated and newly created procedures. Training included structured presentations, walkthroughs of process flows, and practical examples showing how the procedures should be applied. Competency assessments were introduced to confirm understanding and to provide evidence suitable for regulatory inspection.
Furthermore, QSN supported the development of a training matrix that linked each role to required procedures and competencies. This ensured that the organisation could maintain compliance independently after project completion.
Conclusion
The QMS gap assessment and integration project demonstrated how systematic evaluation, scientific documentation practices, and targeted training can achieve compliance with PIC/S PE 009 and Annex 3 requirements for radiopharmaceutical sponsors and importers. QSN’s approach ensured that the company established a robust QMS aligned with TGA expectations, implemented consistent quality processes, and built internal capability for ongoing compliance.
Quality Systems Now provides GMP and regulatory compliance support to therapeutic goods manufacturers, testing laboratories, and biotechnology organisations.
