PIC/S Compliance
Comprehensive PIC/S compliance services with specialist support for PIC/S member authority inspections.
PIC/S Inspection Readiness, End to End
The PIC/S GMP Guide underpins inspection expectations across more than fifty participating authorities. We prepare manufacturers for PIC/S inspection through the same disciplined sequence we use for EU readiness — assess, remediate, verify independently, then submit and liaise.
Our partner network includes auditors who have worked inside PIC/S member inspectorates, which means the pre-inspection audit reflects how the inspection will actually be conducted.
At a Glance
- PIC/S reviews and gap analysis
- Pre-inspection audit by PIC/S partner
- Authority submission and liaison
Need this scoped for your facility and target market? A senior consultant will give you a candid read at no cost.
Request a ProposalOur Five-Phase PIC/S Framework
Assessment through to authority liaison and closure.
PIC/S Reviews & Gap Analysis
Systematic review against the PIC/S GMP Guide and relevant annexes, producing a risk-ranked gap register with remediation effort estimates.
PIC/S Audit Preparation
Closure of identified gaps across the quality system, documentation, validation and personnel training, with inspection dossier preparation.
Pre-Inspection Audit by PIC/S Partner
Independent mock inspection by a partner auditor experienced in PIC/S member authority inspection practice.
Application Submission to PIC/S Authorities
Preparation and submission of the application pack with supporting technical documentation.
Final Liaison with PIC/S Authorities
Support through inspection hosting, observation response, CAPA submission and formal closure.
Why Sites Fail PIC/S Inspection
The recurring themes in our gap assessments.
Incomplete documentation
Procedures that describe an idealised process rather than the one actually performed on the floor.
Data integrity weaknesses
Shared logins, disabled audit trails and unreviewed electronic records.
Environmental control
Insufficient qualification and monitoring of classified areas and utilities.
Training gaps
Training records that show attendance but not demonstrated competency.
Services That Pair With This
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