QUALIFICATION & VALIDATION BASIC PRINCIPLES: LAWS, ORDINANCES AND STANDARDS
The requirement to carry out a qualification is prescribed by laws whose implementation is governed by ordinances which are in turn based on detailed requirements set out in pharmacopoeias, guidelines and standards.
The terms GLP and GMP are often quoted in this context.
These terms refer to guidelines drawn up to ensure that quality is maintained by different target groups based on different goals and statutory bases.
This stands for Good Laboratory Practice whose guidelines apply to laboratories carrying out non-clinical laboratory studies. GLP issues guidelines to these laboratories to ensure the quality of the results of laboratory studies you carry out.
These include safety tests to prove the safety of test items contained in medicinal products, plant protection products and biocides, cosmetic products, veterinary medicinal products, as well as in food additives, animal feed additives and industrial chemicals.
The manufacturing process of products in these categories falls outside the remit of GLP.
The GLP requirements are prescribed in § 19a ff of the German Chemicals Act.
Section 2 of the principles of GLP states that
Equipment which is used for your laboratory studies must have an appropriate construction and adequate capacity and the proper functioning of physical and chemical test systems must be ensured.
As a laboratory operator you can provide this proof by qualifying your equipment
We would be pleased to carry out for you the qualification of your equipment with GLP-compliant documentation.
Manufacturers to whom the EU guidelines for good manufacturing practice apply include manufacturers of medicinal products, active substances, cosmetics as well as foodstuffs and animal feed. These guidelines set out directions for manufacturing companies to follow to ensure the quality of their production processes and the production environment.
Manufacturers of medicinal products in Germany have to comply with various laws including the German Medicinal Products Act.
The implementation of this law is regulated in the German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV) which implements the principles and guidelines based on GMP-EU guidelines for medicinal products for human and veterinary use for the European Union.
§5 German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV)
“Premises and their equipment used for manufacturing processes for products under sections 3 and 5 which are of critical importance for product quality must be tested for their suitability (qualification).”
We would be glad to carry out for you the qualification of your equipment with GMP-compliant documentation
When does equipment have to be qualified and when do processes have to be validated?