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

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

11.0 Analytical specificity: (i) This section should describe interference and cross ...

(ii) Directors, executives and personnel responsible for carrying out evaluation and ...

(vii) the registration holder shall inform forthwith, any change of existing expert ...

2. Personnel: (i) organisation chart showing the arrangements for key personnel; (ii) ...

Ethics Committee This section shall document that the clinical investigation was cond ...

PROVIDED that where deficiencies that can be rectified, are pointed out by the Centr ...