Quality manual: The manufacturer shall establish and maintain a quality manual that i ...

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

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

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

(e) all personnel shall bear clean body covering appropriate to their duties. Smoking ...

Where product requirements are changed, the manufacturer shall ensure that relevant d ...

Data may be recorded by electronic data processing systems or other reliable means, b ...

After the NDA is accepted the various section of the application should undergo concu ...