7 Process Validation
ing that these are validated and ensure a level of quality assurance that is at least equal to that described in the EU guidelines. The EU guidelines, therefore, have the character of prefabricated expertise representing modern scientific and tech- nological standards for drug product manufacturing and testing.
Materials produced in or for the United States are expected to meet the Current Good Manufacturing Practices for Finished Pharmaceuticals as defined in 21CFR Parts 210 and 211 (see chapter D.1). While the USA and EU have similar GMP requirements, they are not identical as some expectations may differ. How- ever, compliance with one area's GMP will generally be found to be in reasonable compliance with the others.
In January 2011, the US FDA issued a new Guidance for Industry which is spe- cifically written to address process validation (see chapter D.2). This new Guidance replaces the 1987 Guidance issued by the FDA and aligns Process Validation with a lifecycle concept and the FDA/ICH Guidances Q8(R2) Pharmaceutical Development (see chapter E.8), Q9 Quality Risk Management (see chapter E.9), and Q10 Pharmaceutical Quality System (see chapter E.10). FDA is interested in incorporating a lifecycle approach which uses modern concepts associated with development, risk management and quality.
The process validation guidance covers several categories of drugs in the USA. They include:
Biological and biotechnology products
Finished products (medicinal products) and active pharmaceutical ingredi-
as well as:
The drug constituent of a combination (drug and medical device) product
In accordance with article 10 §3 of Directive 2003/94/EC (see chapter C.2) and the CGMP regulations and drug laws of the USA (see chapter D.1 and chapter D.16), it is incumbent upon all European and United States manufacturers to validate new manufacturing procedures and other significant changes.
The procedures applied in manufacturing must be validated in line with mod- ern scientific and technological standards. Critical phases in a manufacturing pro- cedure must be revalidated on a regular basis. When test preparations are used, the manufacturing process must be validated as a whole as far as this is indicated, and the production development phase must be allowed for; critical processing steps must always be validated. All steps taken for the design and development of the manufacturing process must be documented in full.
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