Reporting Categories

CDER has published guidances, including the SUPAC (scale-up and postapproval changes) guidances, that provide recommendations on reporting categories. 

Section 506A of the Act provides for four reporting categories that are distinguished in the following paragraphs. 

A minor change is a change that has minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as these factors 

Handbook of Pharmaceutical Manufacturing Formulations Semisolid Products 

An applicant can submit one or more protocols (i.e., comparability protocols) describing tests, validation studies, and acceptable limits to be achieved to demonstrate the absence of an adverse effect from specified types of changes. A comparability protocol can be used to reduce the reporting category for specified changes. A proposed comparability protocol should be submitted as a Prior Approval Supplement if not approved as part of the original application. 

---

The 4,5,6,7-tetrahydro-2,1-benzisoxazole group is the most reported category. The action of hydroxylamine on )3-diketones produced a mixture of 2,1- and 1,2-benzisoxazoles (Scheme 186). Ring opening gave )3-ketoacids which, under subsequent alkali treatment, degraded to diacids (67AHC(8)277). 

Do not list the name of a chemical that does not appear in Table II, such as individual members of a reportable category. For example, if you use silver nitrate, do not report silver nitrate with its CAS number. Report this chemical as "silver compounds which has no CAS number. 

The benefit for producers submitting a CP is that, upon approval of a CP, the FDA can designate, where appropriate, a reduced reporting category for future... 

For the purposes of determining the reporting category for moves between buildings, the terms different manufacturing site and same manufacturing site mean ... 

In several places throughout the guidance, different reporting categories are proposed for changes to or the addition of certain components based on whether the... 

Within the broad reporting categories of vessels (tankers and barges) and facilities (pipelines, tanks batteries, and other onshore facilities) in the period 1984—1993, numbers of reported spill incidents were roughly equivalent 42,000 incidents from vessels and 38,000 from facilities. Over this period, the vessels spilled a much larger cumulative amount of oil 45 million gallons from vessels versus 15 million gallons for facilities. Major incidents can dominate these totals. Two vessel spills account for around one-third of the vessel totals. 

Focus Reports, short reports on specific aspects of an industry, and complete market reports. Industry report categories include life sciences and biotechnology and medical and pharmaceutical products. Recent titles include Freedonia Focus on Medical Equipment, Cosmetic Surgery Products to 2007, Drug Delivery Systems to 2007, and Medical Adhesives and Sealants to 2007. 

---