This guidance provides recommendations to sponsors of new drug applications (NDA’s), abbreviated new drug applications (ANDA’s), and abbreviated antibiotic applications (AADA’s) who intend, during the post approval period, to change: SU: Scale-up during original dossier assessment. Note that this is not SU during development. Consider changes made after the Biobatch PAC: Post-PQ/post-approval, i.e. Variations. … Read more
QUALIFICATION: Qualification is the planning, carrying out and recording of tests on equipment and systems, which form part of the validated process, to demonstrate that it will perform as intended. All manufacturing equipment, laboratory instrument and supporting utilities shall be considered for qualification. After successful completion of qualification exercise, the Equipment / instrument / Utilities … Read more
The premises used for warehousing, manufacturing, processing, storage, packaging labeling and testing purposes shall be; WAREHOUSING AREA: PRODUCTION AREA: ANCILLARY AREAS: QUALITY CONTROL AREA: REFERENCE: 1. Schedule M 2. 21 CFR art 210 & 211 3. WHO Technical Report Series 908
