GMP is a term that was introduced in 1962 by the US Food and Drug Administration (FDA). The term is synonymous for a collection of behaviour measurements and instructions that have to be taken into consideration during the production and handling of certain products (e.g. pharmaceuticals, food products, cosmetic products and veterinary medicines etc.) with the main goal being that these products are reproducible and reliable in the desired quality.

European Drug Master File (EDMF) as well as US Drug Master File (USDMF) are special documents intended to provide sufficient and all inclusive information about the drug substance to the relevant authority with the main objective to serve as a reference data base in case of an application which refers to this DMF.

To identify the still existing gaps and deficiencies with view to international (EU / US) GMP-compliance standards. In addition, to help to prepare for the important inspections performed by the individual authorities (e.g. FDA) or customers.

To establish documented evidence which provides a high degree of assurance that the production process will consistently produce a product meeting its pre-determined specifications and quality attributes.

To provide documented evidence, that production equipment including buildings, rooms, premises and utilities (water systems, HVAC, steam generator, a.o.) are installed and functioning within anticipated operating ranges and perform as intended and prescribed within the User Requirement Specifications…

There should be an adequate number of personnel qualified by appropriate education, training and experience. Training should be regularly conducted by qualified individuals and should cover as a minimum the particular operations that the employee performs and GMP as it relates to the employee’s functions.

In order to verify compliance with the principles of GMP regular internal audits should be performed in accordance with an approved schedule. This also includes the auditing of important suppliers to assure the quality of the incoming goods (e.g. raw materials).

To establish documented evidence which provides a high degree of assurance that the individual cleaning processes will consistently reduce the impurities to a predefined value which assures that there is no detrimental impact on the product produced or handled within the cleaned equipment.

To establish documented evidence that provides a high degree of assurance that computerized systems which could have an impact on product quality (e.g. ERP, DCS, PCS, LIMS, Excel Spread Sheets) will consistently perform as intended in their operational environment according to predetermined specifications and quality attributes and to assure that recorded data and information are safe and unchangeable.

To carefully analyze the production process including rooms, premises, equipment and supporting utilities based on a process flow diagram (and on-site visits, if necessary) to identify and evaluate the specific risks and define measures as well as CCPs to control the risks to assure the safety of the individual product using the principles of HACCP as laid down in the “Codex Alimentarius”.

To carefully review the basic concept and the design of a plant based on general documents such as layout drawings, Master Plans, facility description, URS, etc, and/or on-site checks and to provide comments and details that helps – if necessary - to modify the design of the plant to finally comply with the relevant GMP requirements.