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Why Do We Need to Batch Produce and use Batch Numbers?

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2 June 2016 No comments

A batch, according to the US FDA is a definite amount of API that is necessary to develop a constant quality and character of the drug. The amount should be in a specific limit and must be manufactured during the identical cycle of manufacture. A batch therefore is a specified amount of API or materials that are processed in in one or more ways becoming homogenous in the process.

Batch Number

According to the FDA a batch number is a certain designation that is printed on the drug’s label that traces the batch number and permits the manufacturing and production of batch history including the control and all levels of the manufacturing that needs to be traced and review.

It is important that all batches of tablets are given an identifying number straight after coming from the rotary tablet press (or any type of pill press) or capsule filler and before going to the packaging stage.

Importance of the Batch Number for Pharmaceutical Companies

Batch number is also called as “lot number”. The importance of the batch and the batch number typically starts at the manufacturing plant. Batches are maintained based on:

  • Quantity
  • Manufacturing cycle
  • Expiry date
  • Weight of the active ingredient
  • Excipient

The importance of the batch is best understood from drugs that are manufactured in New Zealand. According to the code of conduct of New Zealand Ministry of Health with regards to the drug manufacturing, is that should there be any problem, it can be traced back through the batch number present. The act ensures that the operator will measure the active ingredients depending on the batch number. When in the manufacturing plant, the operator will also receive a different batch record for each different medicine or drugs to be prepared. The batch record is then documented and is considered as legal paper. The record must show the product formula and the steps needed to prepare the product.

According to the regulatory guidelines, each drug batch is provided with a unique identifying number that is written on the batch documentation. The specified batch is then use all throughout the process and should also be printed on the labels clearly after the manufacturing process and during the packaging. A sample of each batch is then kept for shelf-life plus a year. When a lot or a batch of a drug is done and completed then all equipment must be sanitized and cleaned according to the regulatory condition. The rationale behind this is to prevent any contamination that may start when starting out a new drug. The QA department should also check and test if the results are clear or problem.

The exact lot or batch number on behalf of which, one can check the entire manufacturing history during that time. One can check the expiry and manufacturing date. The prices of the specified batch can be checked.

Importance of the Batch Number for the Ministry of Health

The lot number or batch number is important and should be place on the bottles, packs and cartons as specified by the Ministry of Health of all countries. The lot number is important as they may be required especially when the vaccine or capsule is recalled or there is a failure with regards to the quality of the batch.