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FACILITY AUDITS

SERVICE DESCRIPTION

Facility audits are an organized and systematic means to evaluate an organizations level of compliance with CGMPs. Audits are conducted by reviewing several if not all of the Quality System Elements within an organization. A general scheme of systems for auditing the manufacture of drugs and drug products consists of the following:

Quality System. This system assures overall compliance with CGMPs and internal procedures and specifications. The system includes the quality control unit and all of its review and approval duties (e.g., change control, reprocessing, batch release, annual record review, validation protocols, and reports, etc.). It includes all product defect evaluations and evaluation of returned and salvaged drug products.

Facilities and Equipment System. This system includes the measures and activities which provide an appropriate physical environment and resources used in the production of the drugs or drug products. It includes:
     • Buildings and facilities along with maintenance
     • Equipment qualifications (installation and operation); equipment calibration  and preventative maintenance; and cleaning and validation of cleaning processes as appropriate. Process performance qualification will be evaluated as part of the inspection of the overall process validation which is done within the system where the process is employed
     • Utilities that are not intended to be incorporated into the product such as HVAC, compressed gases, steam and water systems.

Materials System. This system includes measures and activities to control finished products, components, including water or gases that are incorporated into the product, containers and closures. It includes validation of computerized inventory control processes, drug storage, distribution controls, and records.

Production System. This system includes measures and activities to control the manufacture of drugs and drug products including batch compounding, dosage form production, in-process sampling and testing, and process validation. It also includes establishing, following, and documenting performance of approved manufacturing procedures.

Packaging and Labeling System. This system includes measures and activities that control the packaging and labeling of drugs and drug products. It includes written procedures, label examination and usage, label storage and issuance, packaging and labeling operations controls, and validation of these operations.

Laboratory Control System. This system includes measures and activities related to laboratory procedures, testing, analytical methodology development and validation or verification, and the stability program.

DAS has extensive experience in facility auditing and subsequent corrective action plan generation and execution.

WHO WILL VALUE FROM THE SERVICE

The following organizations will benefit from these services:

     • New companies who are establishing a CGMP Quality Audit System
     • Existing companies who are acting proactively to prevent regulatory action from FDA
     • Companies who have already been subject to regulatory action from FDA
     • Companies making the transition from ISO 9000 standards to 21 CFR 210 and 211 regulated work
     • Any organization looking to upgrade their level of CGMP compliance and receive an outside unbiased opinion of their compliance status

PAST EXAMPLES

Some of Delphi’s past work has involved serving as part of the FDA third party expert consultant contingent for companies who are under consent decree. Our efforts with these companies included intensive auditing and reporting functions followed by corrective action plan generation, and verification of completed corrective actions. We have also assisted companies in managing their outsourced contract work, and acted as reviewers for results generated by numerous contract research organizations.

ADMINISTRATION

All consulting service contracts are individually negotiated. Please contact us directly for more details or to request a proposal or site visit.

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