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Quality System Review

The manufacturers must build and maintain a quality system that is suitable for design or production of a specific pharmaceutical or medical device, and regularly review its suitability and validity. The date and results of the quality system review should be on the record and can be traced back to the past.
 
There are two phases to the evaluation of the quality system. The first phase is to evaluate whether the quality department has performed all procedures relating to the review and approval of production, quality control and quality assurance, and to ensure that these procedures are appropriate for their intended use. This also includes a related record keeping system. The second stage is to assess the data collected to identify quality issues and to connect to other major systems for inspection. For each notification project, the manufacturer should have written and approved procedures and cited documentation. One may, should go through the inspection, verify that the manufacturer to comply with written procedures. These ranges are not limited to the finished product of the API (Activate Pharmaceutical Ingredients), but may also include starting materials and intermediates. These ranges are not only likely to show defects within the system but may show defects within other systems that will ensure the scope of expansion. All areas under the system should be covered; The actual depth of coverage may vary depending on the planned inspection strategy, depending upon the circumstances found.
 
Service contents include:
1. Audit the manufacturer's current quality system.
2. Ensure the quality system meet the requirements of FDA and develop the quality policies and objectives for the manufacturer
3. Propose improvement suggestion to the current quality system.

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