Contamination Control Strategy (CCS) Webinar | 21 May 2025

The 2022 revision of the PIC/S Guide to GMP for Medicinal Products (PE 009-17) Annex 1 is expected to be adopted by the Therapeutic Goods Administration (TGA) in 2025 and Contamination Control Strategy (CCS) has emerged as a key new requirement. While CCS under Annex 1 is central for sterile drug manufacturers, it is also applicable for non-sterile manufacturers.

"The intent of the Annex is to provide guidance for the manufacture of sterile products. However, some of the principles and guidance, such as contamination control strategy, design of premises, cleanroom classification, qualification, validation, monitoring and personnel gowning, may be used to support the manufacture of other products that are not intended to be sterile such as certain liquids, creams, ointments and low bioburden biological intermediates, but where the control and reduction of microbial, particulate and endotoxin/pyrogen contamination is considered important. Where a manufacturer elects to apply guidance herein to non-sterile products, the manufacturer should clearly document which principles have been applied and acknowledge that compliance with those principles should be demonstrated."

PE 009-17 Annex 1 Manufacture of sterile medicinal products, 1 Scope

There are at least 16 elements defined in Annex 1 to consider when putting your CCS together and SeerPharma has referenced some examples of each that may be relevant to your operations:

i.  Design of both plant and processes including the associated documentation

• Facility drawings, floor maps, process maps, open/closed processing

ii.  Premises and equipment

• Buildings, design, cleanability / sterilisable, single use

iii.  Personnel

• Qualification and training, health monitoring, hand washing, hygiene, gowning, personnel monitoring

iv.  Utilities

• Drawings, schematic diagrams, utility specification(s), testing and monitoring

v.  Raw material controls – including in-process controls

• Vendor qualification, specification(s), acceptance testing, labelling, storage and handling

vi.  Product containers and closures

• Specification(s), acceptance testing, washing, sterilisation, Extractables and Leachables (E&L), Container Closure Integrity Testing (CCIT)

vii.  Vendor approval (i.e. key component suppliers, sterilisation of components, SUS and critical service providers)

• Risk-based approach to vendor qualification, routine requalification, escalation process, quality/technical agreement(s)

viii.  Management of outsourced services and availability/transfer of critical information between parties (e.g. contract sterilisation providers)

• Vendor qualification, service/quality agreement, specification, certificate of analysis/sterilisation, acceptance testing

ix.  Process risk assessment

• Aseptic processes, campaign manufacturing

x.  Process validation

• Process Performance Qualification (PPQ) Batches, Aseptic Process Simulation (APS) / Media Fill

xi.  Validation of sterilisation processes

• Initial and routine validation, bioburden testing, biological indicators

xii.  Preventative maintenance - maintaining equipment, utilities and premises (planned and unplanned maintenance) to a standard that will ensure there is no additional risk of contamination

• Dedicated tools/equipment, activities during facility shutdown

xiii.  Cleaning and disinfection

• Frequency, efficacy studies, rotation of disinfectants, sporicidal agent, post clean monitoring

xiv.  Monitoring systems - including an assessment of the feasibility of the introduction of scientifically sound, alternative methods that optimize the detection of environmental contamination

• Building management systems, environmental monitoring program,

xv.  Prevention mechanisms - trend analysis, detailed investigation, root cause determination, corrective and preventive actions (CAPA) and the need for comprehensive investigational tools

• Periodic/management review, trending, trending, effectiveness review

xvi.  Continuous improvement (based on information derived from all other elements)

• Product Quality Review (PQR), Periodic/management review, trending, effectiveness review

The revised GMP Annex 1 doesn’t just require isolated controls—it calls for a comprehensive documented Contamination Control Strategy (CCS). This will be a big undertaking for some companies, as it is not just a matter of referencing existing SOPs, but assessing the relationship between each of the 16 parameters.

What does that mean in practice?

For instance, how could material transfer into the cleanroom have an impact on the cleanroom environment? Are you transferring on a trolley through a dedicated airlock? Is that trolley (and the trolley wheels) transitioning from a lower (dirtier grade) into a higher (cleaner grade)? What contamination could you be bringing into the cleanroom? Can we mitigate that risk or do we need to put in a control measure?

Join us on Wednesday 21^st May to gain some insights into the CCS requirements to help you get your documentation ready.

You can also directly leverage SeerPharma's experience in preparing, reviewing and refining compliant Contamination Control Strategies for many GMP licensed organisations to ensure your company is implementing best-practices to protect product quality and patient safety by engaging our Consulting services. Contact us to explore your needs and how we can help.

What Else is Happening In The Annex 1 Space?

PDA Annex 1 Implementation : Inspection Ready Conference & Workshop 2025

17-18 June | Bangkok, Thailand

SeerPharma will be presenting on the topic of Cleanroom Design and Environmental Monitoring: Meeting Annex 1 Standards at the upcoming PDA Annex 1 Implementation : Inspection Ready Conference & Workshop. Click here to learn more and register here.