Pharmaceutical Facility Setup & GMP Compliance Consulting
Facility design and SOP systems built to FDA cGMP guidelines from day one.
What this covers
Most compliance findings are not caused by careless operators. They are designed in - a room that cannot hold its pressure differential, a corridor that forces clean and dirty flows to cross, a procedure written for a machine the plant does not own. By the time an inspector sees it, the fix is capital work.
This engagement front-loads that risk. Layout, flow, environmental controls and the documentation system are worked out against current FDA cGMP guidelines before the walls go up, by the person who would otherwise be assessing them.
We plan and commission manufacturing facilities against current FDA cGMP guidelines - layout and flow, environmental controls, material and personnel segregation, and the documentation system that has to hold up under inspection. Corporate SOPs are written to your actual process, not adapted from a template. Work is led directly by a GMP Auditor, so compliance gaps get caught at the design stage rather than during your first audit.
Included capabilities
- 01Facility setup per FDA / cGMP guidelines
- 02Corporate SOP development
- 03Regulatory & GMP compliance consulting
- 04Audit readiness and gap assessment
Who this is for
- Manufacturers fitting out a first facility or a new suite
- Operations teams preparing for an FDA or customer audit
- Companies whose SOPs no longer match how the line actually runs
- Contract manufacturers taking on regulated product for the first time
What you actually receive
Documents and outcomes, not hours. Each item is something you can hand to an inspector, a supplier or your own team.
- 01
Facility layout and flow plan
Room-by-room layout with material, personnel and waste flows separated, and classification and pressure cascade defined per area.
- 02
Corporate SOP set
Procedures written to your actual process and equipment - operable as written, not adapted from a generic template.
- 03
Gap assessment report
Where the current facility, process or documentation departs from cGMP expectations, ranked by inspection exposure.
- 04
Audit readiness pack
The documentation trail assembled and cross-referenced so it can be produced on request rather than reconstructed.
The sequence for this engagement
- 01
Walkthrough and gap assessment
On-site review of the existing space, process and documentation against cGMP expectations.
- 02
Layout and classification
Room layout, flow separation, area classification and the pressure cascade that supports them.
- 03
SOP and documentation build
Procedures, forms and records written to the process as designed, with training points identified.
- 04
Commissioning and audit prep
Verification that the built facility behaves as specified, and a dry run against the documentation.
Facility Setup & Compliance questions
- How early should a GMP consultant be involved in a facility build?
- Before the layout is fixed. Classification, pressure cascade and flow separation are decided by the floor plan, and changing them after construction means capital rework. Ztech Consulting & Tech Inc is normally engaged at the planning stage, alongside the architect or contractor.
- Can you write SOPs for a facility you did not design?
- Yes. SOP development is frequently a standalone engagement. The work starts with observing the process as it currently runs, so the written procedure matches the line rather than describing an idealised version of it.
- What does an FDA audit readiness assessment cover?
- Facility and environmental controls, equipment qualification status, batch record and SOP completeness, training records, and the traceability between them. Findings are ranked by how likely they are to be raised and how hard they would be to remediate under observation.
What usually goes with this
Formulation Development
Solid dose, powder and coating formulation from bench through scale-up.
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Equipment Solutions
Sourcing, installation, in-process equipment, validation and preventive maintenance.
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Free initial consultation
Need facility setup & compliance?
Describe the facility, product or line and you will get a direct technical answer from Mohammed Z. Rahman, GMP Auditor.