Bare ActsThe drugs and cosmetics act, 1940

Section 24

Reprocessing and Recoveries: 24

Amendment status not verified — confirm the current text below against the official source.

Reprocessing and Recoveries: 24.1. Where reprocessing is necessary, written procedures shall be established and approved by the Quality Assurance Department that shall specify the conditions and limitations of repeating chemical reactions. Such reprocessing shall be validt.. 24.2. If the product batch has to be reprocessed, the procedure shall be authorized and recorded. An investigation shall be carried out into the causes necessitating re- processing and appropriate corrective measures shall be taken for prevention of recurrence. Re-processed batch shall be subjected to stability evaluation. 24.3. Recovery of the product residue may be carried out, if permitted, in the master production and control records by incorporating it in subsequent batches of the product.

Section 24 – The drugs and cosmetics act, 1940 | DailyLaw.ai