Lot (production)

from Wikipedia, the free encyclopedia

Under one lot , in logistics also batch (French: ˈʃaʁʒə to French charger , 'loaded'), in production also series , in process engineering also batch (English bæt͡ʃ , originally 'an oven filling during baking'), in the area of ​​the Medical and pharmaceutical legislation also lot (engl. shortly lɔt , quantity ') or part (French., part'), comprises all the units is meant in a batch process or a batch production produces be. These were created, manufactured or packaged under the same conditions, or according to EN  1041, this is the "defined quantity of substances or a number of medical devices, including end products and accessories, which are used in a process or in a series of related Procedure is processed ".

Such a whole is usually assigned a clear alphanumeric lot designation , serial designation , batch number or batch designation (lot designation for medical products according to 93/42 / EEC or 98/79 / EC for in-vitro diagnostics and MPG exclusively as a pictogram according to EN  ISO  15223-1 LOT permitted, abbreviated for pharmaceuticals according to AMG § 10, labeling exclusively as Ch.-B. ). This designation is then noted on the products of the corresponding lot.

In many situations, it is helpful to assign a product to a unique lot using its lot designation, even after delivery and sale to the customer. In the area of ​​pharmaceuticals and medical devices, this labeling is not optional, but rather an international legal requirement. The guaranteed batch tracing ensures that if a production defect is detected, a product is purposefully withdrawn from the market and that the production defect can be investigated. Only those units of this product need to be recalled whose lot names correspond to the contested lots.

Legal regulations for batch designations
Product area Regulation in EU Regulation in DE Regulation in AT Regulation in CH
Food EU regulation 178/02 Lot labeling regulation
Medical device LOT Regulation (EU) 2017/745 (MDR)

or 93/42 / EEC until the end of the transition period

LOT Medical Devices Act LOT Medical Devices Act # Austria


drug CH B. Medicines Act (Germany) Medicines Act (Austria)

See also

Individual evidence

  1. ANSI / ISA-88 (a standard for batch-oriented control: Batch Control).
  2. DIN EN 61512
  3. § 32 AMG ( German Medicines Act ): "State batch test".
  4. § 26 AMG ( Austrian Medicines Act ): "Batch release".
  5. a b DIN EN 1041: 2013-12 Provision of information by the manufacturer of medical devices: 3.1 batch, batch; 3.2 batch number; Lot number; Batch number; Series designation.