Achieving and maintaining compliance with GMP (Good Manufacturing Practice) and ISO 13485 standards is critical for therapeutic goods manufacturers, testing laboratories, and biotechnology companies operating in regulated markets. These frameworks provide the foundation for product quality, patient safety, and regulatory approval. However, organisations frequently overestimate their level of compliance, overlooking systemic weaknesses or inconsistent implementation. Identifying gaps in compliance is not only a proactive strategy to prevent regulatory findings—it is an essential part of building a sustainable, inspection-ready quality management system.

At Quality Systems Now, we specialise in GMP and ISO 13485 compliance, offering strategic guidance, audits, and remediation programs tailored to the Australian and international life sciences industries. This article outlines a structured approach to identifying compliance gaps and strengthening your quality system.

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Understanding the Compliance Landscape

Therapeutic goods manufacturers and medical device companies in Australia must meet specific regulatory requirements set by the Therapeutic Goods Administration (TGA). The TGA adopts the PIC/S Guide to GMP for medicines and mandates ISO 13485 for medical devices. Each standard defines the expectations for quality systems, documentation, manufacturing controls, validation, supplier management, complaint handling, and corrective action processes.

ISO 13485:2016, for instance, emphasises risk-based approaches, regulatory compliance across product lifecycle stages, and the integration of quality management principles. The PIC/S Guide to GMP similarly stresses quality risk management, data integrity, and continual improvement. Failure to meet these standards may result in delayed market access, regulatory warning letters, or even suspension of licenses.

Identifying gaps is the first step in closing compliance deficiencies and mitigating these risks.

Conducting a Comprehensive Gap Analysis

A gap analysis is a systematic comparison between your current quality system and the requirements of the applicable standard. It identifies missing elements, areas of nonconformance, and practices that fall short of regulatory expectations. At Quality Systems Now, we conduct both document-based and on-site gap analyses to examine quality systems in-depth.

Key elements evaluated during a GMP or ISO 13485 gap analysis include:

• Quality Manual and Policy alignment with regulatory frameworks

• Adequacy of standard operating procedures (SOPs)

• Roles and responsibilities of Quality Assurance (QA) and Quality Control (QC)

• Batch documentation and traceability

• Supplier qualification processes

• Calibration and maintenance of equipment

• Complaint handling and adverse event reporting

• Internal audits and management reviews

• Risk management systems

• Data integrity practices

• Document control and change management

Each of these areas must be assessed for both presence (are they documented?) and effectiveness (are they implemented consistently and monitored?).

Documentation Deficiencies

One of the most common areas of noncompliance is incomplete, outdated, or inconsistent documentation. SOPs may exist in name but not reflect current practices. In ISO 13485 environments, the absence of a defined document hierarchy or uncontrolled updates can trigger nonconformities. For GMP environments, incomplete batch records, lack of validation documentation, and failure to document deviations can undermine compliance.

Our experience at Quality Systems Now shows that many organisations underestimate the importance of maintaining a compliant document control system. It must include version control, defined approval pathways, training records, and timely reviews. Any missing or obsolete documentation represents a tangible compliance gap.

Inadequate Risk Management Integration

Both GMP and ISO 13485 require a structured, risk-based approach to decision-making. However, in practice, risk management is often treated as a standalone task rather than a continuous, embedded process.

Key deficiencies include:

• Lack of formal risk assessments during change control

• Incomplete Failure Mode and Effects Analysis (FMEA)

• Absence of risk mitigation strategies in design and development

• Minimal involvement of cross-functional teams in risk evaluations

• Poor linkage between risk registers and CAPA (Corrective and Preventive Action) systems

Risk management must inform process design, supplier selection, and post-market surveillance. At Quality Systems Now, we assist clients in integrating risk-based thinking across their quality systems to meet both ISO 14971 (for medical devices) and ICH Q9 (for GMP) expectations.

CAPA System Weaknesses

Corrective and Preventive Action systems are a cornerstone of compliance. Yet many organisations implement CAPAs reactively, without adequate root cause analysis or follow-through. Gaps often include:

• Superficial investigations

• Inappropriate assignment of responsibility

• Lack of timelines and resources for implementation

• Missing or inadequate effectiveness checks

• CAPAs that are closed prematurely

A mature CAPA process requires detailed documentation, evidence-based investigation tools (e.g., 5 Whys, Ishikawa diagrams), and cross-functional collaboration. Regulators assess the robustness of your CAPA system as a measure of quality system maturity. Quality Systems Now provides CAPA training and workflow optimisation services to help close these gaps.

Supplier and Outsourced Process Control

ISO 13485 and GMP both require rigorous control of suppliers and contract manufacturers. However, supplier management is often underdeveloped. Gaps may include:

• Inadequate supplier qualification protocols

• Absence of quality agreements

• No process for ongoing performance monitoring

• Limited or no supplier audits

• Lack of traceability in component sourcing

To address these risks, Quality Systems Now assists clients in building end-to-end supplier management systems that include risk-based supplier categorisation, audit schedules, and measurable performance metrics.

Training and Competency Deficits

Compliance is not possible without a competent, well-trained workforce. We frequently observe training programs that focus only on initial onboarding, with no refresher training, competency evaluation, or tracking mechanisms.

Key training-related gaps include:

• Incomplete training records

• Untrained temporary or contract staff

• No mechanism for evaluating understanding or effectiveness

• Generic training not tailored to role-specific responsibilities

• Failure to retrain following procedural changes or deviations

TGA and ISO 13485 auditors routinely request evidence of training for all staff performing quality-related tasks. We offer tailored training programs that address both technical content and regulatory expectations, with an emphasis on continuous learning.

Internal Audit Program Limitations

An internal audit program is a regulatory requirement under both GMP and ISO 13485. However, gaps are often found in how these audits are planned, executed, and documented. Warning signs include:

• Infrequent audits or audits that do not cover all processes

• Audits performed by unqualified personnel

• No corrective action linked to audit findings

• Failure to analyse audit results for trends

• No management review of audit outcomes

A robust internal audit system should be risk-based, cover the full scope of operations, and serve as a preventive tool. Quality Systems Now helps clients build compliant audit programs, train internal auditors, and develop metrics for audit performance.

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Identifying and addressing gaps in GMP and ISO 13485 compliance is not merely a corrective exercise—it is a strategic investment in regulatory readiness, product quality, and organisational resilience. In a landscape where regulators such as the TGA expect not just compliance but continuous improvement, a proactive approach to gap identification is essential.

At Quality Systems Now, we support therapeutic goods manufacturers, laboratories, and biotech companies in building inspection-ready systems. Whether through gap analyses, training, remediation planning, or ongoing compliance support, we help our clients not only meet but sustain the standards expected by regulators and patients alike.

Organisations that routinely examine and improve their systems are best positioned for success in both local and global markets. Identifying your gaps today is the first step toward operational excellence and long-term compliance.