Importance of Batch number in Pharmaceuticals

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Batch number in Pharmaceuticals

What is a Batch?

According to US FDA a batch is a specific quantity of an intermediate or API required having a uniform character and quality. This quantity should be in specified limits and must be produced during same cycle of manufacture. In other sense, a batch may be a specified quantity of material or API processed in one or more processes so that it becomes homogeneous.

According to Pakistan Drug Act, 1976 batch is a quantity of any drug or medicine that is produced and manufactured during a specific period under specific conditions.

What is Batch number?

According to Pakistan Drug Act, 1976 Batch number is specific designation printed on the label of a drug or medicine that locates the batch and allows the production or manufacturing history of batch plus all stages of manufacturing and control need to be reviewed and traced. Examples of batch number are given as under:

Batch number in Pharmaceuticals

You can see the Batch number is mentioned and printed on above packs.

What is importance of Batch for Pharmaceutical manufacturer?

Batch number is also mentioned as lot number. Importance of Batch and Batch number starts from the manufacturing plant. Batches are maintained according to quantity, manufacturing cycle, manufacturing and expiry dates, weight of active ingredients and excipient etc. Batch importance can be understood from example of manufacturing of drugs like capsules, tablets, capsules and syrup etc. in New Zealand. According to New Zealand code of conduct about drugs manufacturing given by the Ministry of health, it is must that all the medicine should be traced through batch number if there develop any problem. Due to this act the operator will weigh the required active ingredients according to batch no. In manufacturing plant the operator is given a separate batch record for each separate drugs and medicines to be prepared. Batch record is documented and that documents are considered as legal paper. Batch record must have the product formula and the steps required for the preparation of that product.

According to regulatory requirements each batch of a drug is given a unique identifying number which is written on the batch record (documentation). Further this specific batch or lot number is used for throughout manufacturing process and also printed clearly on the labels pasted on products or drugs after manufacturing and during packaging. Further SOPs explain that samples of each batch must be kept for shelf-life of product plus one year. When batch of a specific drug like capsule or tablet is completed, then all equipment used for the manufacturing must be cleaned according to regulatory conditions. Reason for this is to avoid any contamination when starting manufacturing of any next drug. Further, Quality control department must check and test whether results are clear or not.

This is the specific lot or batch number on behalf of which we can check the complete history of manufacturing during that period. We can check the manufacturing and expiry dates of medicine. There can be checked prices according to specific batch number. Prices if are changed increased or decreased are also on the basis of batch number.

What is importance of Batch for Ministry of Health?

Batch numbers are very important to mention on the packs, cartons and medicine bottles etc. according to instructions of Ministry of Health of all the countries of the world. So lot or batch numbers are very important to print and mention because they are required in some serious conditions like when a vaccine, tablet or capsule batch is recalled or has documented immunogenic failure or there is found deficiency in quality of a batch.

References:

http://www.pipingnews.com/fda%20Definitions.htm

http://www.ppma.org.pk/pdf/The%20Drugs%20Act,%201976.pdf

http://www.missionpharma.com/batchtracking

http://nzic.org.nz/ChemProcesses/biotech/12F.pdf

http://www.health.gov.sk.ca/sim-chapter4

About the Author

Anjum Rehman's picture
Author: Anjum Rehman

I am an experienced Pharmacist and MBA.

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