Production
- 21 CFR Part 11- Electronic Records and Signatures
- German Drug Law
- Meat Hygiene Law
- Good Manufacturing Practices (GMP)
- Good Laboratory Practices (GLP)
- Good Storage Practices (GSP)
Today, the proper warehousing of the raw materials, packaging, and final goods is seen as an integral part of a GMP-oriented quality system. Mandatory are:
The FDA rule 21 CFR Part 11 specifies the requirements covering the use of electronic records of GMP-relevant information and the suppositions for using electronic signatures. This is to ensure that electronic information and electronic signatures underlie the same requirements as hard copies. For example, this applies to production protocols, data acquisition, quality control management, as well as the archiving of electronic data and documents. In addition, it must also be ensured that only competent and authorised people approve and release the documents and processes.
The German Drug Law also applies to veterinary medicinal products. This is to ensure that consumers are protected from eating meat and other foods of animal origin that are contaminated with veterinary medical residues.
The Meat Hygiene Law and the Poultry Hygiene Law specifies the examination of the animals and spot checks of the animals and meat for veterinary medicinal residues and other substances.
- safeguarding of all manufacturing processes
- preventing mix-ups
- preventing impurities
- production hygiene
- quality control
- documentation of manufacturing and controls
- organisation and personnel
- premises and facilities
- operating instructions
- records of results
- archiving and compulsory period of record-keeping
- warehouse documentation systems
- premises and facilities
- intermediate storage areas
- warehouse conditions and monitoring of the surroundings
- distribution and batch traceability
- status-labelling
The maximum allowable residue quantity ordinance, the maximum permissible contaminant ordinance, and the ordinance pertaining to substances with pharmacological
The food hygiene ordinance regulates the production, processing, and marketing of foodstuffs with respect to hygiene.
The Foodstuffs and Commodities Act contains numerous bans and rules for health protection and to prevent deceit.
The Precautionary Radiation Protection Act and its corresponding ordinances specify the maximum limits of radiation allowed in foodstuffs.
The Additive Ordinance specifies in which products and in what amounts additives, such as dyes and preservatives, are allowed.
Documentation
- BRC Global Standard
- General Food Law (GFL)
- International Food Standard (IFS)
The IFS was developed by German retailers in order to check and audit manufacturers of private brands in the food branches. The basis for this is the Good Food Safety Initiative (GFSI) and its goal, international security standards to stipulate for businesses, which supply retailers with private brands. In addition, it ensures a continual improvement process and documentation.
- Novel Foods Ordinance
Throughout Europe, the Novel Foods Ordinance regulates the requirements for the licensing procedure and the labelling of novel foods, including foods from genetically altered organisms and such, whose consumption has been previously unusual.
- Food-Labelling Ordinance
The food labelling ordinance contains exact specifications as to how food is to be labelled.
The BRC (British Retail Consortium) Technical Standard was developed in 1998 by a group of British retailers and has been established as the common standard for food retail businesses. Its goal is to ensure uniform security for the complete chain of suppliers, thus minimizing risks and enhancing customer trust. In March of 2003, the standard was renamed BRC Global Standard.
The General Food Law is the EU-regulation 178/2002. In January 2002, parts of the GFL became valid and from 2005 on, it will become valid in all aspects. The GFL specifies batch traceability through all processes, i.e. from the farm to the table and defines measures for food safety and quality management. It also requires systems for risk management as well as the involved risk evaluation and communication.
