Getting a manufacturing site licensed or a laboratory accredited

Establishing a manufacturing site or laboratory is a significant undertaking for any organisation operating in the therapeutic goods, biotechnology or analytical testing sectors. Beyond securing suitable premises, installing equipment and recruiting qualified personnel, an organisation must demonstrate that its operations meet the regulatory and technical standards applicable to the activities it intends to perform.

For manufacturers, this may involve obtaining a manufacturing licence or other regulatory authorisation. For testing laboratories, it commonly involves achieving accreditation against an internationally recognised competence standard, such as ISO/IEC 17025. Although licensing and accreditation are sometimes discussed together, they serve different purposes and are administered through different processes.

Understanding the distinction is essential. A manufacturing site may need regulatory approval before it can legally manufacture particular therapeutic goods, while a laboratory may need accreditation to demonstrate that its testing activities are technically competent and produce reliable results. The precise obligations depend on the products, services, jurisdiction and intended scope of operations.

Understanding the Difference Between Licensing and Accreditation

A manufacturing licence is a regulatory authorisation that permits an organisation to undertake specified manufacturing activities, subject to applicable legislation and regulatory conditions. In Australia, the Therapeutic Goods Administration (TGA) regulates the manufacture of therapeutic goods, including medicines and biologicals, under the relevant provisions of the Therapeutic Goods Act 1989 and associated requirements.

The applicable authorisation depends on the type of therapeutic goods and the activities being performed. Australian manufacturers of medicines generally require a TGA manufacturing licence unless an exemption or other applicable arrangement applies. Manufacturing activities may include production, processing, packaging, labelling and testing, depending on the scope of the licence and the relevant regulatory requirements.

Accreditation, by contrast, provides formal recognition that a laboratory is competent to perform specified testing, calibration or related activities. In Australia, the National Association of Testing Authorities (NATA) is the national accreditation body and assesses laboratories against relevant international standards and technical requirements. ISO/IEC 17025 is the principal competence standard for testing and calibration laboratories.

Accreditation is scope-specific. A laboratory is not automatically accredited for every test it performs simply because it has achieved accreditation. Its approved scope identifies the methods, measurements, materials or activities for which competence has been assessed.

It is also important to recognise that accreditation does not automatically replace regulatory obligations. A laboratory performing testing for a regulated manufacturer may need to satisfy additional GMP expectations, contractual requirements or regulatory controls. Similarly, a manufacturing licence does not establish that every analytical method used by the site is suitable or that every laboratory activity is accredited.

Establishing the Regulatory Pathway Before Investing

One of the most common sources of delay is beginning facility development before the regulatory pathway has been properly defined. Organisations may invest in premises, equipment and personnel only to discover that the proposed activities require different authorisations, facility arrangements or technical controls.

The first step is to define exactly what the site will do. For a manufacturing operation, this means identifying the product categories, manufacturing steps, dosage forms, production technologies and intended markets. It is also necessary to determine whether activities will be conducted internally, outsourced or divided between several facilities.

For a laboratory, the scope should identify the types of samples, testing services, analytical techniques, measurement ranges and intended uses of results. A laboratory testing raw materials for internal manufacturing control may have different obligations from one providing independent release testing or testing clinical trial materials.

The organisation should then identify the relevant regulatory and accreditation requirements. These may include GMP, ISO/IEC 17025, applicable pharmacopoeial requirements, occupational health and safety, environmental controls, biosecurity requirements and state or territory licensing obligations.

A documented regulatory assessment provides a basis for facility design, quality system development, equipment procurement and recruitment. It should also identify activities that require external authorisation before operations can commence.

Designing a Facility That Can Meet the Required Standards

Facility design has a direct influence on compliance. A building that is inexpensive to establish but difficult to clean, maintain, control or monitor can create persistent operational problems.

For manufacturing sites, the design should support the prevention of contamination, mix-ups and errors. The required arrangements depend on the products and processes involved. Relevant considerations can include personnel and material flows, segregation, controlled environments, temperature and humidity management, cleaning facilities, storage conditions and access control.

The layout should reflect the manufacturing process rather than relying on procedures to compensate for unsuitable physical arrangements. Where different products or activities present contamination or cross-contamination risks, appropriate segregation and control strategies must be established.

Laboratories also require carefully considered layouts. Sample receipt, preparation, analysis, storage and disposal should be organised to protect sample integrity and prevent contamination. Where activities involve incompatible materials, biological hazards or different environmental conditions, the facility should provide appropriate separation and controls.

Utilities are another important consideration. Water systems, compressed gases, ventilation, electrical supply and environmental monitoring arrangements should be suitable for their intended use. Critical systems may require qualification, calibration, routine monitoring and maintenance.

Facility design decisions should be documented and justified. Early engagement between engineering, laboratory or manufacturing personnel, quality assurance and regulatory specialists can identify weaknesses before construction or refurbishment makes them expensive to correct.

Building a Quality Management System

Neither a manufacturing licence nor laboratory accreditation can be achieved sustainably through facility design alone. The organisation must establish a functioning quality management system (QMS) that governs its activities and provides evidence that processes remain controlled.

For a GMP manufacturing site, the quality system should address the applicable GMP requirements and provide appropriate oversight of production, quality control, documentation, deviations, change control, corrective and preventive action (CAPA), supplier management, validation and product quality review.

Responsibilities must be clearly assigned. Production personnel are responsible for performing activities in accordance with approved instructions, while the quality function must have sufficient authority and independence to perform its oversight responsibilities. Quality decisions should be supported by documented evidence and should not be subordinated to production pressures.

A laboratory seeking ISO/IEC 17025 accreditation needs a management system that supports technical competence, impartiality and consistent operation. This includes document control, personnel competence, equipment management, method verification or validation, measurement traceability, quality assurance of results, management of nonconforming work and internal audits.

The system must be appropriate to the laboratory's scope and risks. A collection of procedures is not sufficient if personnel do not follow them or if records fail to demonstrate that activities were performed as required.

For both types of organisation, the QMS should be implemented before formal assessment. Procedures need to be approved, personnel trained, records generated and the effectiveness of controls evaluated through routine operation.

Demonstrating Technical Competence

Technical competence is central to both manufacturing compliance and laboratory accreditation, although the evidence required differs according to the activity.

Manufacturers must demonstrate that processes are suitable for their intended purpose and consistently produce products meeting established specifications. This may require process validation, equipment qualification, cleaning validation, analytical method validation and appropriate validation of computerised systems.

The extent of validation should be justified by the process, product and associated risks. Validation is not simply a collection of reports prepared for an inspection. It is a lifecycle activity that includes planning, execution, evaluation, approval and continued verification where appropriate.

Laboratories must demonstrate that their personnel, methods and equipment are capable of producing technically valid results. Analytical methods may require verification or validation depending on whether they are standard methods, modified methods or methods developed by the laboratory.

Equipment must be suitable for its intended measurement range and maintained in a controlled state. Calibration arrangements should provide appropriate measurement traceability, while intermediate checks and maintenance help demonstrate ongoing performance.

Personnel competence must also be documented. Qualifications and experience are relevant, but they do not automatically establish competence for every method or task. Training, supervised practice, practical assessment and authorisation records provide stronger evidence that individuals can perform assigned work reliably.

Preparing for Regulatory Inspection or Accreditation Assessment

A formal inspection or accreditation assessment should not be the first occasion on which an organisation evaluates whether its systems work.

For manufacturing sites, the regulatory process may involve review of the proposed activities and assessment of the premises, equipment, quality systems and operational controls. The nature and timing of assessment depend on the application, product category and regulatory pathway. Organisations should confirm the applicable requirements with the relevant authority before assuming that a particular inspection sequence or timeframe will apply.

For laboratories, the accreditation process generally includes an application defining the requested scope, review of relevant documentation and an assessment of the laboratory's technical and management system capabilities. Assessors may examine records, observe testing activities, interview personnel and evaluate whether methods and equipment are appropriately controlled.

In either case, preparation should include a structured internal readiness assessment. This should examine whether procedures are implemented, records are complete, personnel understand their responsibilities and equipment or processes are operating as intended.

Internal audits should be sufficiently independent and technically informed to identify weaknesses. Findings must be investigated, corrected and assessed for effectiveness. Simply closing an audit finding through a revised procedure does not establish that the underlying problem has been resolved.

Management should also ensure that personnel can explain their work accurately. Staff should understand the procedures relevant to their roles, know how to report problems and be able to locate the records that demonstrate their activities.

Managing Suppliers, Contractors and Outsourced Activities

New manufacturing sites and laboratories frequently depend on external providers for specialist services. These may include equipment suppliers, calibration providers, maintenance contractors, contract manufacturers, testing laboratories, consultants and information technology providers.

Outsourcing an activity does not necessarily remove the organisation's responsibility for controlling the associated quality risks. Suppliers should be assessed according to the criticality of the materials or services they provide.

Qualification may involve review of licences or accreditation scopes, technical capabilities, quality systems, relevant experience and performance history. Agreements should define responsibilities, specifications, communication requirements, access to records and arrangements for managing deviations or changes.

For laboratories, external calibration and proficiency testing arrangements may be particularly important. Participation in appropriate proficiency testing or interlaboratory comparisons can provide evidence of ongoing technical performance. Where suitable schemes are unavailable, alternative approaches to monitoring validity of results should be considered and justified.

Manufacturers should ensure that outsourced manufacturing, testing and other critical activities are governed by appropriate technical and quality agreements. Supplier oversight should continue after initial qualification, with performance reviewed at a frequency proportionate to risk.

Avoiding Common Delays and Compliance Problems

Several recurring issues can undermine licensing and accreditation projects. One is an unclear scope. If the organisation cannot precisely define the activities it intends to perform, it becomes difficult to establish the correct facility design, quality controls and assessment requirements.

Another is treating the QMS as a documentation exercise. Procedures written shortly before an assessment may not reflect actual practice, and personnel may be unfamiliar with the controls they are expected to follow.

Inadequate equipment planning can also create significant delays. Equipment may arrive without appropriate specifications, qualification plans, calibration arrangements or maintenance requirements. Critical equipment should be identified early, with acceptance and qualification activities incorporated into the project schedule.

A further problem is underestimating the time required to generate operational evidence. A newly established system needs to be implemented and tested. Training records, environmental monitoring data, equipment records, method performance data, audit findings and management reviews must reflect actual activities rather than assumptions about how the organisation intends to operate.

Finally, organisations should avoid assuming that a licence or accreditation certificate represents permanent compliance. Regulatory obligations and accreditation requirements continue after approval. Changes to products, processes, equipment, premises, personnel or testing methods may require assessment, notification, approval or reassessment, depending on the applicable framework.

Maintaining Compliance After Approval

Achieving a manufacturing licence or laboratory accreditation is an important milestone, but it marks the beginning of ongoing compliance rather than the end of the project.

Manufacturing sites must maintain their GMP systems, control changes, investigate deviations, monitor suppliers and ensure that processes remain capable. Regulatory inspections may occur after licensing, and organisations must be prepared to demonstrate continued compliance.

Accredited laboratories must maintain the competence demonstrated during assessment. This includes ongoing personnel training, equipment calibration, method performance monitoring, internal audits, management reviews and participation in proficiency testing or other suitable quality assurance activities. Changes to the laboratory's scope or technical arrangements should be managed through the applicable accreditation processes.

Both environments benefit from a planned compliance calendar, clear ownership of quality activities and routine review of performance indicators. Management should monitor recurring deviations, overdue CAPAs, equipment failures, audit findings, training gaps and supplier performance. These indicators can reveal weaknesses before they develop into significant compliance issues.

Building the Capability to Operate with Confidence

Licensing a manufacturing site or obtaining laboratory accreditation requires coordination between technical specialists, quality personnel, engineers, operational teams and management. The work is most effective when regulatory requirements are considered at the beginning of facility development and translated into practical systems that personnel can consistently apply.

Quality Systems Now supports therapeutic goods manufacturers, testing laboratories and biotechnology organisations in developing the systems, processes and internal capability needed for regulated operations. This can include regulatory pathway assessment, quality management system development, GMP and ISO/IEC 17025 implementation, validation planning, internal audits, training and readiness assessments.

The objective is not simply to prepare an organisation for an inspection or assessment. It is to establish a facility that can operate reliably, produce defensible evidence of compliance and maintain technical and quality standards as its activities develop.

A well-planned licensing or accreditation project brings regulatory expectations, facility design and operational capability together. When these elements are addressed as an integrated programme, organisations are better positioned to achieve approval, avoid preventable delays and sustain the standards required for long-term operation.