Most tests applied in microbiological QC are described in detail in the different Pharmacopoeias (e.g. EP, USP, and JP). These methods are regarded as being validated – but not

Knowing and applying the GMP regulations is one of the key elements in the manufacture of medicinal products and medical devices.

In the manufacture of sterile medicinal products,

With publication of the Guidance for Industry “Process Validation: General Principles and Practices” 2011, the FDA requires a new direction.

Validation is now a "Life Cycle Process" with 3 stages:<

In the aseptic processing of medicinal products, product quality usually cannot be ensured by means of lab controls of the final product. Process validation by means of media fills is

The ECA Working Group on Analytical Quality Control was founded in 2010 in order to generate a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT