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Autor:  PPAULO
E-mail:  não-disponível
Data:  29/MAR/2012 9:27 PM
Assunto:  Lot or Batch?
 
Mensagem: 

    I am  no barcode or management expert, let alone work in distribution.

   Anyway, I understand that a batch (fornada, partida, produção em uma só unidade de dia/mês/ano  etc) is a smaller unit or even a subunit of the lot.

 

    The quantity produced at one operation (at one run).

 

    On the other hand, the lot numbers may end up (say in the end of the month), in the middle of a batch (say the products made in the 1ºst of the month, or the last day of

the previous month).        Sometimes the lot numbers matches a given batch, then a batch and lot may have the same meaning, and sometimes people simply use the "lot" word for the "batch" and vice versa. 

 

         

     A batch might have to do the expiry date more than the lot in itself, the lot number is more to have a more cronological purpose.

     But then, my view, that of a layman, so it´s just my personal thinking.

 

     I also noticed that a lot number have to do the product history, whereas the batch have to do with the product "family", at the time of its production.

 

--------------------------------------------------

 

http://www.instrumentation.co.za/article.aspx?pklarticleid=6674

Material dispatch and marking

Experience has shown that the batch management database is an ideal source of data for detailed finished goods labels since all the header data (product code, product name, usage notes, batch number, expiry date...) and detail data (typically ingredients) are available in that system. Figure 4 shows a label generated using data from a batch management database.

   

 

 

http://www.medsafe.govt.nz/hot/Consultation/Recall.pdf

b) Report significant defects or concerns to Medsafe through email, fax or by phone (see Appendix 2 for contact details). The following information will be useful if available:

Product name and strength (if applicable)

Supplier

Batch/lot number/serial number (if known)

Expiry date (if applicable and known)

Defect and details of any associated clinical incident

The healthcare professional or laboratory staff member’s view on why the suspected defect is considered significant.

 

 

http://michaelis.uol.com.br/moderno/ingles/index.php?lingua=ingles-portugues&palavra=batch

batch
batch
1 fornada. 2 partida, porção, pilha, punhado, lote, quantidade de alguma coisa feita de uma vez. a batch of letters / uma pilha de cartas. 3 grupo, série...

 

http://www.pharmacyboardkenya.org/assets/files/Guidelines_for_Product_Recall.pdf

 

Guidelines for Product Recall and Product Withdrawal

10. BASIC INFORMATION REQUIRED FOR

RECALL

10.1. Name, strength, pack size, batch/lot number and

any means of identification of the recalled

product

 

 

 

http://www.merriam-webster.com/dictionary/batch

Definition of BATCH

1

: the quantity baked at one time : baking

2

a : the quantity of material prepared or required for one operation; specifically : a mixture of raw materials ready for fusion into glass b : the quantity produced at one operation

 

 

http://www.instrumentation.co.za/article.aspx?pklarticleid=6674

Material dispatch and marking

Experience has shown that the batch management database is an ideal source of data for detailed finished goods labels since all the header data (product code, product name, usage notes, batch number, expiry date...) and detail data (typically ingredients) are available in that system. Figure 4 shows a label generated using data from a batch management database.

 

 

From a Site in the Web:

In-House Manufacturing, Bulk Compounding, Packaging, and Labeling


As with commercially marketed drug products, those produced by the pharmacy must be accurate in identity, strength, purity, and quality. Therefore, there must be adequate process and finished product controls for all manufacturing/bulk compounding and packaging operations. Written master formulas and batch records (including product test results) must be maintained. All technical personnel must be adequately trained and supervised. Packaging and labeling operations must have controls sufficient to prevent product/package/label mix-ups. A lot number to identify each finished product with its production and control history must be assigned to each batch.

 

§ 211.180 General requirements.

(a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137, 3 years after distribution of the batch.


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 English Made in Brazil -- English, Portuguese, & contrastive linguistics
Lot or Batch?  –  Carla B.  29/MAR/2012, 12:01 PM
Lot or Batch?  –  Oiroso_  29/MAR/2012, 1:25 PM
 Lot or Batch?  –  PPAULO  29/MAR/2012, 9:27 PM
Lot or Batch?  –  Carla B.  29/MAR/2012, 10:35 PM

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