Appendix I CONTENTS OF A SITE OR PLANT MASTER FILE The manufacturer shall prepare a s ...

2.0 Device description and product specification, including variants and accessories ...

Recall detail Footnotes i Type of Product: Medicine, Medical Device, or Biological ii ...

10.0 Analytical sensitivity: This section should include information about the study ...

5. Sanitation: Availability of written specifications and procedures for cleaning the ...

4. Equipment: (i) brief description of major production and quality control laborato ...

(v) details of competent technical staff, under whose direction and supervision the s ...

14.0 Definition of Assay Cut-off: This section should provide a summary of analytical ...