Pharmaceutical manufacturing facilities have regulatory obligations around building fabric integrity that extend beyond standard fire safety. A Panel Check assessment provides the documented evidence of composite panel condition that GMP compliance requires.
Back to Knowledge BasePharmaceutical manufacturing facilities operate under regulatory frameworks – including Good Manufacturing Practice (GMP), MHRA requirements in the UK, and EMA guidelines across Europe – that place specific obligations on the integrity of the building fabric. These frameworks require that manufacturing environments are designed, constructed and maintained to prevent contamination, support environmental control, and protect product quality and patient safety.
Composite insulated panels play a central role in creating and maintaining these environments. They are used in cleanrooms, controlled manufacturing areas, cold storage for raw materials and finished products, and throughout the building envelope. Their condition – including the integrity of the panel joints, the cleanliness and soundness of the internal face, and the absence of moisture ingress or core delamination – directly affects the facility’s ability to meet GMP requirements.
A Panel Check assessment of composite panels in a pharmaceutical facility generates the documented evidence of panel condition that supports GMP compliance, regulatory inspections and insurance renewals.
Pharmaceutical manufacturing buildings present a specific fire risk profile. Many processes involve flammable solvents and reagents. Compressed gas systems, electrical distribution and HVAC equipment add to the ignition source inventory. The consequences of a fire in a pharmaceutical facility extend beyond physical damage – loss of a manufacturing site can disrupt supply of critical medicines, trigger regulatory notifications and require re-validation of relocated processes.
Composite panel fire performance is therefore a critical consideration in pharmaceutical buildings. Panel Check’s assessments establish panel type and fire classification across the whole building fabric, assess the integrity of fire compartmentation boundaries, and identify any areas where panel condition compromises fire performance.
Cleanroom and controlled area composite panels have specific requirements that go beyond standard industrial use. The panel joint system must be continuously sealed to prevent ingress of particulates and maintain environmental control. The internal face must be smooth, easily cleanable and resistant to the cleaning agents used in pharmaceutical environments. Any penetrations through panels must be sealed to the appropriate standard for the area classification.
Panel Check’s assessments specifically address these requirements – assessing joint integrity, seal condition, surface condition and penetration sealing across all cleanroom and controlled area panels. Findings are reported in a format suitable for inclusion in facility qualification documentation.
Panel Check assessors follow pharmaceutical site protocols as standard – gowning requirements, access restrictions, contamination control procedures and documentation standards appropriate to the area classification. We understand that in a pharmaceutical manufacturing environment, the survey methodology is itself subject to GMP considerations.
We work with clients’ QA teams to agree a survey protocol before any assessment work begins, and our reports are structured to support site documentation requirements including change control records.
Panel Check’s assessment process for pharmaceutical manufacturing sites is designed to integrate with existing quality system requirements and site procedures.
Before any on-site work begins, Panel Check engages with the client’s QA team to agree a survey protocol. This covers gowning and contamination control requirements for each area to be surveyed, access procedures for cleanrooms and controlled areas, documentation requirements including the use of site-specific permit-to-work systems, and the chain-of-custody procedures for any core samples taken.
The on-site survey covers all composite panel elements – cleanroom walls and ceilings, production area panels, cold storage areas, service corridors and external envelope. For each area, the assessment records panel type and fire classification, joint integrity and sealant condition, surface condition and any damage that could compromise cleanroom classification, and the integrity of penetrations and service interfaces.
In cleanroom areas, Panel Check works with contamination control protocols appropriate to the area classification – including air lock procedures, gowning, and restrictions on the tools and equipment brought into controlled areas. Assessment findings for cleanroom panels are reported in a format suitable for inclusion in facility qualification documentation and change control records.
Remediation recommendations are structured to acknowledge the change control requirements of the pharmaceutical environment – recognising that works in controlled areas require validation activities and that remediation planning must be integrated with production scheduling and regulatory compliance obligations. Panel Check can provide the technical specifications required to support the change control process.
The documentation output of a Panel Check pharmaceutical assessment is designed to integrate with the client’s quality management system. In addition to the standard assessment report, Panel Check can provide findings in a format suitable for inclusion in facility qualification files, change control records and regulatory inspection documentation. We understand that in a GMP-regulated environment, the format and traceability of documentation is as important as the content – and our report structure reflects this.