Facilitating EU GMP certification for OSD, injectable, and biosimilar manufacturing facilities — from initial gap audit through to inspection-ready documentation.
Services & Scope
A.1 GMP Audits
- QMS audit & document update
- Layout/system gap audit
- Vendor audit
- Pre-inspection CAPA
- Data integrity assessment
A.3 Engineering (Guidance)
- Conceptual, basic, and detailed engineering
- Equipment layouts & procurement assistance
- Commissioning, qualification, and validation
A.2 GMP Compliance & Upgradation
- Establishing GMP management systems
- Gap analysis & guideline-based planning
- Implementation & documentation guidance
- Executive training & internal audits
Design Review Engineering
Preliminary facility review, conducted in sequence for a new or upgraded facility.
| Step 1: Master Site Plan | Tailored to requirements, including ground and first-floor architectural production layouts. |
| Step 2: Systems Layout | HVAC systems, equipment layout, and plant section drawings. |
| Step 3: Utilities & MEP | Utility load calculations, sizing, mechanicals, piping, instrumentation, electricals, and UPS. |
| Step 4: Commissioning Review | Validation Master Plan (VMP), risk assessment, and qualification document finalization. |
Qualification Lifecycle
URS to routine use, aligned with current EU-GMP philosophy where risk assessment drives the system lifecycle.
Documents Reviewed & Finalized: Project Validation Master Plan, Validation Master Plan, Risk Assessment, and the full Qualification set (URS, FDS, DQ, FAT/SAT, IQ, OQ, PQ).
Utilities in Scope: HVAC, Purified Water System, Compressed Air, production equipment, and QC/microbiology equipment.
Lifecycle Sequence:
Risk Assessment → URS → Vendor FDS → DQ → Purchase Order → FAT/SAT → IQ → OQ → PQ → Equipment Released for Routine Use
GMP / QMS Review & Update
Facility systems systematically reviewed against global GMP regulations. We provide guidance for protocol/SOP preparation, training support, and documentation review.
Quality System
Quality policy, VMP, equipment qualification, training, risk assessment, SOPs, vendor qualification, recall, data integrity, deviation/CAPA, OOS/OOT, APQR, market complaints, and self-inspection.
Facility & Equipment
Utilities qualification (HVAC, compressed air, water, nitrogen), plant & utility layout review, temperature mapping, preventive maintenance, and equipment qualification.
Material Management
Warehouse receipt/dispatch, batch dispensing, label management, ERP control, and material return to vendor.
Production System
Manufacturing area GMP/BMR/GDP, batch monitoring, scrap & reprocessing, material/man movement, IPQC, gowning, cross-contamination control, line clearance, and log book management.
QC Laboratory System
GLP/GDP/21 CFR Part 11 compliance, autoclave & analyst validation, AMV, audit trail verification, HPLC handling, reference standards, stability programme, and calibration.
Other Systems
HR system elements (job descriptions, medical, pest control, housekeeping, attendance, visitor control), GMP inspection participation, and good hygiene practices.
Document Preparation & Dossier Review
The exact paper trail an EU-GMP audit requires.
- Core EU-GMP Documents: Site Master File (SMF), technology transfer documentation, BMR/BPR, process validation, cleaning validation, and stability protocols for tablet/capsule products.
- Compiled Dossier Review: Review of validation data, stability data, analytical method verification data, specifications & methods of analysis (RM/in-process/PM/FP/stability), elemental & nitrosamine impurities, and the compiled dossier itself.
- Key Inspection Requirements: Serialization facility installed and qualified at the time of inspection; transport validation study completed; SOPs mapped against EU guidance and fully implemented at the site.