Building from scratch
GACP structure, documentation, and processes: everything to set up before first production.
GACP Consultancy
GACP that stands up to audits, buyers, and investors.
GACP compliance is built into daily processes, documentation, and the people who apply it. The month before the audit is too late to start.
No certification promises. Independent technical assessment of current readiness status.
Operators in 12+ countries
GACP · EU GMP · ICH Q7 · ICH Q10
Methodology aligned to EMA criteria
Self-assessment
How aligned is your cultivation with GACP?
Six questions across documentation, cultivation, and traceability. A structured diagnostic before you commission a formal gap assessment.
6 questions, around 5 minutes
Personalised PDF report with archetype classification and gap analysis
Optional 30-minute review call with a Clear consultant
We collect your email at the halfway point. Privacy policy.
PREVIEW
Your Report
Foundation
CoverageYou
Maturity
Optimisation
Methodology
Built on real audit experience.
Based on EMA Good Agricultural and Collection Practice guidance (EMEA/HMPC/246816/2005) and the practical requirements buyers and inspectors apply at EU import stage. Clear's auditors work directly with manufacturers, buyers, and national competent authorities across Europe, applying the same lens that certification audits use.
Sample
The questions that matter.
“Do you maintain documented batch records that demonstrate traceability from seed to harvest?”
“How is your facility currently set up for environmental monitoring during cultivation?”
“Have you defined critical quality attributes for your output materials and do you monitor them at each harvest?”
5 archetypes
Where you stand. What you can do.
Foundation
First stages of the compliance journey. Basic systems and documentation not yet formally in place.
Coverage
Compliance frameworks in progress, with partial implementation. Gap analysis and prioritisation are the main focus.
Maturity
Mature systems with specific gaps remaining. Targeted remediation to close priority observations.
Optimisation
Near full compliance with refinement needs. Audit readiness and continuous improvement as the next horizon.
Next steps
A report, then options.
Right after submission
- ✓Your 3-page PDF report delivered to your email
- ✓Archetype classification with detailed reasoning
- ✓Concrete next steps tailored to your position
If you want to discuss
- ✓Optional 30-minute call with a Clear consultant
- ✓No commitment, no sales follow-up unless requested
- ✓Schedule directly via Zoom Scheduler
Recognition
Six situations that indicate GACP readiness needs work.
01
Production is running but there is no formal quality system structure in place.
02
SOPs exist but are outdated, applied inconsistently, or disconnected from training records.
03
Records are incomplete or would fail under external audit scrutiny.
04
Traceability is fragmented across spreadsheets, informal notes, or verbal accounts.
05
An audit or buyer qualification is approaching and nobody is sure what to show them.
06
Previous audit findings were closed superficially without root cause analysis or verified CAPA.
The problem
Compliance requires more than written procedures.
Most GACP operations have something written. Some SOPs, some records, some procedures. The real issue is documentation that fails under serious scrutiny.
International buyers, certification auditors, and pharmaceutical due diligence teams look for evidence: that you apply your SOPs, keep them current, and that your team follows them in practice.
Who it is for
Recognise your situation.
Each scenario leads to an engagement calibrated to that specific situation.
Active operation
Production is running. Buyers and audits are approaching and the structure needs to be in place.
Documentation review
Outdated SOPs, gaps in records, structure that needs to withstand serious scrutiny.
Preparing for an audit
Audit or due diligence coming up. We need to know where the gaps are before they find them.
Received nonconformities
Open findings from a previous audit. They need a systematic resolution with verified CAPA.
Dealing with buyers or investors
Advanced commercial conversation. We need to show a credible system backed by evidence.
What we do
GACP services across three areas of intervention.
Each area covers a distinct phase of the path to compliance. We can work on a single area or run the full path to readiness.
Area A
Diagnosis
Full GACP gap assessment
Assessment of the operation against GACP requirements. Structured methodology, report scored by operational dimension.
Document system audit
Analysis of SOPs, records, and document structure. Identifies gaps, redundancies, and critical areas.
Traceability analysis
Verifies that the traceability system withstands external scrutiny. End-to-end mapping.
Area B
Document system
Site-specific SOPs
Standard operating procedures written for your specific operation.
Compliant document structure
Architecture with clear hierarchy: quality manual, procedures, work instructions, templates.
Operational record templates
Templates adapted to your processes: batch records, production logs, deviation register.
Change control system
Procedure and documentation to manage changes in a compliant and traceable way.
Area C
Operations
Personnel training
Structured training for the operational team: understanding requirements, executing procedures.
Nonconformity and CAPA management
System to identify, document, analyse, and close deviations and nonconformities.
Pre-audit preparation
Targeted gap assessment, operational checklist, and mock audit to arrive prepared.
Third-party audit support
On-site presence during buyer or certification audits. Technical handling of requests.
Post-engagement monitoring
Periodic verification programme to maintain compliance over time.
Not sure which areas you need?
The gap assessment identifies them. Start there.
Regulatory framework
Four reference frameworks that govern GACP compliance.
GACP compliance draws on several reference frameworks. Understanding which ones apply at each stage is essential for building a defensible system.
How we work
Six phases, zero improvisation.
Each phase has a defined output. You always know where we are and what comes next.
What you get
Thirteen concrete deliverables.
Operational documentation ready for use in your specific context.
Cultivation foundation
Traceability and documentation
Buyer and audit readiness
Why act now
Three reasons readiness cannot wait.
01
International buyers set the bar higher
GACP expectations in European pharmaceutical markets have increased. Those who arrive unprepared lose the commercial conversation at the first due diligence request.
02
Audits surface what preparation hides
A GACP audit without preparation surfaces gaps accumulated over months. Remediation under audit pressure takes longer and costs more than structured preparation.
03
Compliance is a commercial asset
A documented and verifiable GACP system strengthens commercial negotiations, supports investor due diligence, and provides a defensible position in regulatory exchanges.
Who we are
Credentials you can verify.
Frequently asked questions
Frequently asked questions.
A gap assessment today is less expensive than a finding during audit.
A gap analysis starts with a conversation. Tell us about your operation: we will tell you where you stand and what to do.