GMP Facility Design, Qualification, Validation and TGA GMP License

SeerPharma has provided GMP Consulting assistance to support the design, commissioning, qualification, validation and licensing of a new GMP facility for an Australian pharmaceutical contract manufacturer.

The client identified a gap in expertise associated with their new GMP facility design and qualification, and requested SeerPharma to provide suitable resources to enable this project to drive forward. SeerPharma’s efforts have helped the company obtain a TGA GMP license.

SeerPharma also ensured the client's GxP related IT systems (LIMS and SAP ERP) were validated.

To assist, SeerPharma  deployed a Senior GMP Consultant who  participated in project meetings and provided both oversight and advice to the client and their key vendors / suppliers. Our team:

• Provided Quality oversight at project meetings to ensure that key user requirements were met, ensuring quality and TGA GMP licensing timeframes were included and communicated as part of the project plan.
• Participated in Design Review meetings as a Quality / GMP expert to ensure that regulatory and company quality requirements were identified and scoped into the design process.
• Provided quality requirement communications to Vendors and subcontractors.
• Provided quality documentation review for Quality Management System (QMS) documentation including SOP’s, Protocols and Reports.
• Assisted GMP training of new staff with respect to the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-8) currently adopted by the TGA.

In addition, the contracting arm of our business provided a resource to complete GMP facility qualification and GMP facility validation activities as required by the client for when these tasks could not be done with internal resources.

SeerPharma's team of Computer System Validation (CSV) experts also conducted a gap analysis and spent time with the client's IT system owners to review  processes, documents, system validation status, and operating environment. Where systems were found to be non-compliant with TGA expectations, remediation plans and options were prepared.

SeerPharma's approach was risk-based and pragmatic, therefore the remediation plan targeted “sufficient remediation” rather than “gold plating”, and helped the client get to a compliant state with the least amount of cost and effort.

Contact us should you require assistance with Quality Assurance of your GMP facility, processes, equipment or IT systems to local or international regulatory agency standards such as the FDA CFR and EU or PIC/S Guide to GMP.

This post comes from our July 2016 Journal.  You may also be interested in this post:

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