Pharmaceutical Auditing Approach
Intertek design audit and action plans to meet the requirements of pharmaceutical clients to ensure compliance with EC standards, FDA regulations and WHO concerns.
During a pharmaceutical audit process, Intertek takes a "snapshot" of the company's existing quality system, and superimposes it on the reference system, allowing an exact assessment of the company's conformity performance. Intertek's auditing team then recommend a strategic plan of action, which allows the company to achieve the quality assurance required.
A pharmaceutical auditing plan may include corrective actions on:
- Documentation and Record Control
- Manufacturing Process and Equipment
- Validation and Qualification
While the purpose of all audits is the same, the elements and steps involved in the audit process may differ depending on the type of audit required and its applied regulation standards. Working with the company, Intertek takes an active role to ensure corrective actions are instituted and implemented. Any pharmaceutical manufacturing company must be able to prove that it does so with absolute reliability, under optimal secure conditions, and with extreme uniformity to allow for exact reproduction. Therefore, all manufacturing equipment and processes must be qualified and validated to ensure performance.
With its extensive knowledge in various pharmaceutical manufacturing processes, automated computer control systems, laboratory & information systems, and qualification, validation & audit programs, Intertek is qualified to assist clients in assessing and defining their compliance and validation requirements, from individual operating systems to an entire facility, and provides the necessary resources to achieve these objectives. Our Total Quality Assurance expertise enables you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes. Intertek qualification and validation services include:
Design and Review of Validation:
- Facility and Processes
- Material and Product Flows
- Process and System Specifications. GMP policy
- Planning and Follow Up
Pharmaceutical auditing expertise includes writing and review of validation policies, guidelines and SOP from design qualification to performance qualification steps.
System Installation Qualification, Operation Qualification, and Performance Qualification on:
- HVAC and Clean Rooms
- Laminar Flow Hoods
- Safety Cabinets
- Sterilization Systems
- Water System
- Pure Gases Line
- Freeze Dryers
- Aseptic Filling Lines and Production Equipment
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