Control of documents : Documents required by the quality management system shall be c ...

The manufacturer shall ensure that changes to documents are reviewed and approved eit ...

4.2.3 Control of documents : Documents required by the quality management system shal ...

Notes: Central Drugs Standard Control Organization, Ministry of Health and Family Wel ...

3.0 Labelling: The dossier should typically contain a complete set of labeling associ ...

Monitoring plan General outline of the monitoring plan to be followed, including acce ...

(ii) the applicant shall provide adequate space having regard to the nature and numbe ...

(2) Our Authorised agent shall, — (a) act as the official representative for obtainin ...