GMP
The topic is planned and the article has not been written yet. Nothing on this page is published technical guidance.
This article will examine how findings from a GMP gap assessment are captured, classified by risk, and turned into engineering responses with defined evidence, owners, and verification steps. It will also explain why a CAPA plan needs closeout evidence rather than a statement that an action was taken.
If this question is live on your project, you do not need to wait for the article. Tell us about the facility and we can discuss it directly.
01GMP
In preparationThis article will examine how personnel, material, product, and waste routes are mapped at concept stage: gowning sequences, airlock and pass-through placement, and the separation of clean and return routes. It will also explain why these decisions are hard to reverse once structure and HVAC zoning follow the layout.
02Facility Planning
In preparationThis article will examine the first decisions behind a new pharmaceutical plant: product portfolio and dosage forms, sterile or nonsterile scope, capacity and shift assumptions, site constraints, and the regulatory framework of the target markets. It will also explain how these inputs become a brief that design can build on.
03Pharma Engineering
In preparationThis article will examine what each engineering phase is expected to decide and deliver, from zoning and flow strategy at concept stage, through system definitions, equipment lists, and layouts in basic engineering, to coordinated construction drawings and specifications in detailed engineering.
Next step
Share the product type, the current stage and the main constraints. We will respond with a proposed scope and next steps.
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