FDA's New Compliance Program Guidance Manual, Chapter 45 - Biological Drug Products

GMP News No. 714

GMP News
28 April 2006
 

FDA's New Compliance Program Guidance Manual,
Chapter 45 – Biological Drug Products

 
In addition to the Compliance Program Guidance Manual (CPGM) for API manufacturers, which we presented in our GMP News of 16 March 2006, the FDA has in the meantime published a revised version of this document type for biologics. It is intended as a guideline for FDA inspectors.

The Compliance Program Guidance Manual, Chapter - 45 Biological Drug Products is a must-read for everyone whose company is exporting biologics to the USA. It covers both APIs and finished drug products.

The product group of biologics, which lies within the sphere of responsibility of the Center for Biologics Evaluation and Research (CBER), has to comply not only with the "usual" GMP requirements from 21 Code of Federal Regulations (CFR), Parts 210 and 211, and Section 501 (a)(2)(B) of the Food, Drug, and Cosmetic Act, but also with 21 CFR 600-680.

Owing to these comprehensive requirements and the complexity of biologic products as well as of their manufacturing processes, the FDA established the Team Biologics for inspections as far back as 1997. It is supported by the Office of Regulatory Affairs (ORA) and by CBER.

The particularities of biologics are also reflected by the above-mentioned CPGM. Since - apart from these particularities - the document is based on FDA's systems-based approach to inspections, in the following we will give only some examples for additional requirements.

The inspectors' attention is, e.g., drawn to starting materials of animal origin. Testing of these materials has to be in compliance with 21 CFR 600.11 and the specifications in the marketing dossier.

The inspectors have to have a close look at the batch release records and to verify that the raw data are within the limits of the data sent to CBER. This is particularly important against the background that CBER can require samples and batch records of every batch of product at any time and decide itself about the release of the batch in question [21 CFR 610.0(a)].

Another specialty of biologics are Biologic Product Deviations (BPDs). Here, the inspectors have the task of checking whether all deviations have been reported to CBER. Special emphasis is placed on the information flow between the manufacturer and a possible contract manufacturer [21 CFR 600.14(a)].

Furthermore, they have to verify if side effects were reported completely and within the set time limits to CBER [21 CFR 600.80]. 

The attachments to the Compliance Program Guidance Manual include concise descriptions of the product groups and their manufacturing processes for which CBER is competent, e.g. plasma fractionators, vaccines, recombinant products, allergenics.

Our recommendation:
All those who are involved in the quality assurance of biologics should read this document. It provides a very good overview of CBER's current thinking and requirements.
  

We offer the following events on biologics:

GMP Webinar: GMP in Early Phases of Development - Focus on Biopharmaceuticals 
on 29 May 2006, 13:30 - 15:00 h (CEST)

GMP-compliant Development of Biopharmaceuticals - With Site Visit at CMC Biopharmaceuticals, on 15 -17 May 2006 in Copenhagen, Denmark

 
You can download the Compliance Program Guidance Manual, Chapter – 45 Biological Drug Products from FDA's website via this link: http://www.fda.gov/cber/cpg/7345848.htm

Author:
Dr Ulrich Herber
On behalf of the European Compliance Academy
 

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