Changes Annual Report

The following are examples of changes that are considered to have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of a product as these factors may relate to the safety or effectiveness of the product. 

A minor change in an existing code imprint for a dosage form for example, changing from a numeric to alphanumeric code 

Addition or deletion of a code imprint by embossing, debossing, or engraving on a solid dosage-form drug product other than a modified-release dosage form 

A change in the order of addition of ingredients for solution dosage forms or solutions used in unit operations (e.g., granulation solutions) 

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Rutherford E (1904) The succession of changes in radioactive bodies. Philos Trans R Soc 204 169-219 Rutherford E, Soddy F (1902) The cause and nature of radioactivity Part 1. Philos Mag 4 370-396 Soddy F (1910) Radioactivity. In Annual Reports on the Progress of Chemistry, Vol. 7. The Chemical Society, London, p 257-286... 

Marrett D.J., Page A.L., Bradford G.R., Cardenas R., Graham R.C., Chang A.C. Background levels of soil trace elements in southern California soils, Annual report submitted to Southern California Edison Co., Rosemead, CA, University of California, Riverside, CA, 1992. 

Benjamin, S. A., Hahn, F. F. and Jones, R. K. (1972b). Hematologic changes in dogs with radiation-induced hemangiosarcomas, page 226 in Fission Product Inhalation Program Annual Report 1971-1972, Report No. LF-45 (Lovelace Foundation, Albuquerque, New Mexico). 

Participants should be provided with a detailed information pack on joining the scheme. Communication with participants should be by newsletter or annual report together with a periodic open meeting participants should be advised of changes in scheme design. Advice should be available to poor performers. Feedback from laboratories should be encouraged so participants contribute to the scheme s development. Participants should view it as their scheme rather than one imposed by a distant bureaucracy. 

Manufacturing process modification Document manufacturing changes in annual reports Approval required for every manufacturing change before implementation Submit manufacturing changes and vahdation documents to FDA 30 days prior to product distribution"... 

Filing documentation—A prior approval supplement with all data including the accelerated stability data is required. This change should also be documented in the annual report along with the long-term stability data. 

Filing documentation—A supplement should be hied showing the changes being effected. Long-term stability test data should be included in the annual report. 

Filing documentation required—Changes being effected should be identihed in a supplement. Long-term stability data are reported in the annual report. 

Chemistry documentation—(1) Application/compendial release requirements, (2) notification of change to the FDA and submission of updated batch records in the annual report, and (3) one batch should be on long-term stability with results being provided in the annual report. 

Filing documentation—Prior approval supplement with justification for change long-term stability data must be reported in the annual report. 

Filing documentation—A prior approval supplement must be filed with justification for the change. Long-term stability data should be submitted in the annual report. 

Annual Report For a minor change (minimal potential to have effect on quality and performance), all information has to be submitted to the FDA in the next annual review and the product made with the change can be distributed. 

I <5% w/w change based All drugs Stability Annual report... 

Changes being effected supplement (accelerated stability data for MR and no stability data for IR) Annual report (longterm stability data for MR and IR)... 

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