FAQ – EcoGrow Quality & Compliance

All production areas and equipment comply with strict regulatory and operational requirements:

• Cleanrooms qualified according to EU GMP guidelines.
• Performance validation for HVAC, pressure differentials, temperature & humidity.
• Full equipment qualification (IQ/OQ/PQ) ensuring consistent functionality.

We maintain strict product integrity throughout storage and handling:

• Defined storage conditions (temperature, humidity, light protection).
• Clear labeling, status control (Quarantine/Released/Rejected) & full traceability.
• Sealed systems and protective packaging to maintain product quality.

We follow the key GMP principle: “If it’s not documented, it didn’t happen.”

• Comprehensive SOPs for all operations.
• Complete batch, cleaning, maintenance & calibration records.
• Documentation ensures traceability, consistency & compliance.

Risk control applies at every production stage:

• Secure access control and CCTV monitoring.
• Data integrity compliant with ALCOA+ principles.
• Established change control, deviation & CAPA systems.

Products are released only after meeting all GMP requirements:

• Full QC testing — identity, purity & safety.
• Batch release authorized by a Qualified Person (QP).

We maintain a robust contamination control strategy to prevent microbial, particulate, and cross-contamination:

• Continuous environmental monitoring.
• Controlled personnel, material, and air flows.
• Validated cleaning & disinfection procedures with approved agents.

Only trained and properly equipped staff may enter production areas:

• Regular GMP, hygiene, safety & PPE training.
• Restricted access only for authorized personnel.

Yes — all critical manufacturing and analytical operations are validated:

• Validation of manufacturing processes and cleaning procedures.
• Analytical method validation confirming reliable and repeatable results.

All utilities in contact with product meet pharmaceutical standards:

• Validated HVAC systems with HEPA filtration.
• Routine quality testing of water systems (WFI, PW), gases & other media.

Always. EcoGrow maintains continuous inspection readiness:

• Regular internal and supplier audits.
• Prepared for regulatory inspections (e.g., SÚKL, EMA, FDA).
• Strong CAPA system ensuring corrective and preventive actions.