SERVICES

NEW FACTORY CONSTRUCTION

New Plant Construction


You must know how important it is to get the design right when it comes to build a new manufacturing plant. KRB Consulting has set up extensive design capabilities to allow us to provide GMP & GEP compliance consulting to make sure a correct and right start, we will support until the plant is inspected and approved by the local Authorities.

• Drawing and conceptual design review: review conceptual designs and drawings to identify potential design irregularities or risks.

• Compliance audits during new plant construction: send team to be onsite to audit during construction especially core plant construction and installation, to ensure the science and ease of use of construction and installation.

• GEP compliance: assist in GEP system building or consulting services for new plants who do not have GMP systems in place.

• Gap analysis for the current systems: review the current systems to identify the possible gaps and guide for CAPAs.

• QMS establishment or upgrading: guide for the new plant to set up QMS or guide the plant already have the systems to upgrade.

• Validation support: guide or assist for validation and re-validation after the renovation.

• Process transfer support: provide technical guidance for process transfer, process verification and cleaning validation.

• SME Training: coach and train core personnel and SME to improve the overall quality capabilities.

• Mock audit: perform audit and mock audit after the upgrading.

• Official inspection support: send on-site expert team to support for official inspection to quick response and take actions.

• GMP interpreter: provide GMP interpreter (English, Spanish, Korean) during official inspection.

• CAPA response: assist in CAPA plans and response after the inspection, until finally pass the inspection.


Key words:

NEW FACTORY CONSTRUCTION

New Plant Construction

Category:

SERVICES


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Phone number:400-0123-669

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Address:A805, Tower A, Chaowai SOHO, 6B Chaowai Street, Chaoyang District, Beijing 100020

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