Compliance Program Guidance Manual - Inspection of Biological Drug Products - 7345.848 - Regulatory Issues

Compliance Program Guidance Manual - Inspection of Biological Drug Products - 7345.848
BACKGROUND
CBER-regulated biological drug products include fractionated blood and their recombinant analogues; antitoxins; allergenic products; vaccines; products that consist of manipulated, cultured or expanded human cells, and gene transfer products that introduce genetic material into the body to replace faulty or missing genetic material.
CBER is responsible for, among other things, ensuring that these biological drug products are safe and effective, and are in compliance with FDA and other applicable laws and regulations. Biological drug products are licensed under the provisions of Section 351 of the Public Health Service (PHS) Act (42 U.S.C), and because biological drug products also fall within the definition of a drug, which is found in Section 201(g)(1) of the Food, Drug, and Cosmetic Act (FD&C Act), they are inspected under the provisions of both the PHS Act and the FD&C Act.
Biological drug products are subject to the applicable regulations promulgated under both Acts, including the Current Good Manufacturing Practice regulations (CGMPs), which are found in Title 21 Code of Federal Regulations (CFR), Parts 210 and 211, and the Biologics regulations, 21 CFR Parts 600-680. Section 501(a)(2)(B) of the FD&C Act requires that biological drug products be manufactured in compliance with CGMPs. In addition, while the CGMP regulations apply to the manufacture of biological drug products, the same CGMP principles apply for the manufacture of biological drug substances under Section 501(a)(2)(b) of the FD&C Act, and the Biologics regulations under 21 CFR Part 600.
Establishments must also comply with their biologics license application (BLA) commitments, and applicable standards. These biological drug products include a wide variety of indications, dosage forms and manufacturing processes, all of critical importance to promoting and protecting the public health. For example, vaccines prevent childhood or adult diseases, or may be used in response to certain acts of bio-terrorism. Allergenic extracts enable doctors to diagnose allergies and help their patients avoid life-threatening anaphylactic reactions. Similarly, fractionated products may be used to prevent otherwise fatal hemorrhages or to prevent miscarriages from maternal-fetal blood incompatibilities. To help ensure that industry produces these important biological drugs to be consistently safe, pure, potent, and effective, FDA has for many years regularly conducted CGMP inspections of each establishment on at least a biennial basis.
To provide more effective and efficient regulation of biological drug products, the Office of Regulatory Affairs (ORA) and CBER established Team Biologics in 1997 to conduct routine and compliance follow up CGMP inspections of biological drug product manufacturers, including blood establishments. Team Biologics brought together and continues to utilize the investigative skills of ORA and the medical/scientific and product expertise of CBER, to promote and protect the public health through coordinated, integrated assessments of the compliance status of biological drug manufacturers.
Complete manual can be viewed online.