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Quality Services
 

Facility Design Manufacturing Quality Audit Training Due Diligence FDA / CMC

 

An independence Quality organization is a fundamental requirement for regulatory compliance under cGMPs, QSRs, GTPs and GLPs.  We assist in the development and review of our clients' quality organizations and participate in preparation of suitable documents and document control systems.  The quality organization must have the authority to fulfill the following regulatory tasks and responsibilities:

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Approve or reject all components, materials, containers / closures, in-process materials, packaging materials and labeling.

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Approve or reject all bulk substance (active pharmaceutical ingredient - API) and final products.

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Establishment, operation and control (approval/rejection) of documentation systems.

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Standard Operating Procedures (SOPs) - Approximately 80 general procedures are required by cGMPs and approximately 50 are required by QSRs.  In addition, facility and manufacturing specific procedures may increase the total number from a few hundred to over a thousand for larger operations.

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Specifications for components, materials, containers / closures, in-process materials, packaging materials, labeling and for API and final products.

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Master and batch production and control records (cGMPs), device history records (QSRs), HCT/P manufacturing and tracking records (GTPs) or non-clinical study protocols and reports (GLPs).

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Validation/qualification protocols, calibration and maintenance records, as-built facility drawings and other documents.

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Documented training of employees and/or control (approval/rejection) of training performed by others.

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Auditing (both internal and external) to ensure regulatory compliance and to qualify contractors and vendors.

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Quality control laboratories for analytical and microbiological testing.

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Interaction with regulatory authorities, agencies and inspectors (although this is responsibility is often performed by a separate regulatory organization).

The QSIT (Quality System Inspection Technique) process used for FDA inspections by the Office of Regulatory Affairs looks at the Quality organization first and then at one or more other cGMP / QSR functions.

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