21.01.2014 |

LOGFILE No. 33/2012 - Biological Active Substances

Comparison of Different Versions of Annex 2 EU Guide to GMP Part I

Maas & Peither AG - GMP Publishing (November 2012)

Camparison  -  PDF file

Manufacture of Biological Medicinal Products for Human Use

Original 2004

Manufacture of Biological Medicinal Substances and Products for Human Use

Draft 2010

Manufacture of Biological Active Substances and Medicinal Products for Human Use

Final January 2013

Comments Maas & Peither
Scope Scope Scope  

The methods employed in the manufacture of biological medicinal products are a critical factor in shaping the appropriate regulatory control. Biological medicinal products can be defined therefore largely by reference to their method of manufacture. Biological medicinal products prepared by the following methods of manufacture will fall under the scope of this annex (1).

Biological medicinal products manufactured by these methods include: vaccines, immunosera, antigens, hormones, cytokines, enzymes and other products of fermentation (including monoclonal antibodies and products derived from r-DNA).

The methods employed in the manufacture of biological edicinal substances and products are a critical factor in shaping the appropriate regulatory control. Biological medicinal substances and products can be defined therefore largely by reference to their method of manufacture.

This annex, along with several other annexes of the Guide to GMP, provides guidance which supplements that in Part I and in Part II of the Guide. There are two aspects to the scope of this annex:

The methods employed in the manufacture of biological activesubstances and biological medicinalproducts for human use ('biological active substances and medicinal products') are a critical factor in shaping the appropriate regulatory control.

Biological active substances and medicinal products can be defined therefore largely by reference to their method of manufacture. This annex provides guidance on the full range of active substances and medicinal products defined as biological.

This annex is divided into two main parts:

a) Part A contains supplementary guidance on the manufacture of biological active substances and medicinal products, from control over seed lots and cell banks through to finishing activities, and testing.

b) Part B contains further guidance on selected types of biological active substances and medicinal products.

This annex, along with several other annexes of the Guide to GMP in EudraLex Volume 4, provides guidance which supplements that in Part I and in Part II of that Guide. There are two aspects to the scope of this annex:

The scope for active substances and biological medicinal products for human use is now more precise.

Additionally the concept of part A and B is already introduced earlier in the document.

a) Microbial cultures, excluding those resulting from r-DNA techniques; a) Stage of manufacture - for biological active substances to the point immediately prior to their being rendered sterile, the primary guidance source is Part II. Guidance for the subsequent manufacturing steps of biological products are covered in Part I. For some types of product (e.g. cell-based products) all manufacturing steps need to be conducted aseptically. a) Stage of manufacture - for biological active substances to the point immediately prior to their being rendered sterile, the primary guidance source is Part II. Guidance for the subsequent manufacturing steps of biological products are covered in Part I. The reference to aseptic manufactured active substances was withdrawn.
b) Microbial and cell cultures, including those resulting from recombinant DNA or hybridoma techniques; b) Type of product - this annex provides guidance on the full range of medicinal substances and products defined as biological. b) Type of product - this annex provides guidance on the full range of medicinal products defined as biological. Slight editorial changes.
c) Extraction from biological tissues

These two aspects are shown in Table 1, it should be noted that this table is illustrative only and not meant to describe the precise scope.

It should also be understood that in line with the corresponding table in Part II of the Guide, the level of GMP increases in detail from early to later steps in the manufacture of biological substances but GMP principles should always be adhered to. The inclusion of some early steps of manufacture within the scope of the annex does not imply that those steps will be routinely subject to inspection by the authorities.

These two aspects are shown in Table 1, it should be noted that this table is illustrative only and is not meant to describe the precise scope. It should also be understood that in line with the corresponding table in Part II of EudraLex, Volume 4, the level of GMP increases in detail from early to later steps in the manufacture of biological active substances but GMP principles should always be adhered to.The inclusion of some early steps of manufacture within the scope of this Annex does not imply that those steps will be routinely subject to inspection by the authorities. Only editorial changes and detailed definition for active substances.
d) Propagation of live agents in embryos or animals (Not all of the aspects of this annex may necessarily apply to products in category a). Although antibiotics are not included as biological products, however where biological stages of manufacture occur, guidance in this Annex may be used. Guidance for medicinal products derived from human blood or plasma is covered in Annex 14 and for non-transgenic plant products in Annex 7. Antibiotics are not defined as biological medicinal products, however where biological stages of manufacture occur, guidance in this Annex may be used. Guidance for medicinal products derived from fractionated human blood or plasma is covered in Annex 14 of EudraLex, Volume 4, and for non-transgenic plant products in Annex 7. Slight editorial changes.

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