Monday 18 December 2017

Batch Procedures in Pharmaceutical Industry


A batch is a specific quantity of an intermediate required having a uniform character and quality. This quantity should be in particular limits and should be created during same cycle of manufacture. A batch may be a specific quantity of material or API ( Active Pharmaceutical Ingredient) processed in one or more processes so as to retain the homogeneity.

Biophar Group is a pharma franchise which says that batch number is a precise description printed on the brand of a drug or medicine that locates the batch and lets the production or manufacturing history of batch with all stages of manufacturing and  quality checks which has to be assessed.

 Batch number can also be termed as a lot number. The third party manufacturing further adds that it all starts from the inception of manufacturing process. These batches are maintained according to quantity in relates to the manufacturing cycle with manufacturing and expiry dates and composition of ingredients. The importance of batch number can be very well understood through manufacturing of drugs like capsules, tablets and syrup. The company gives strong weightage in the conduct of drug manufacturing and says that all the medicine can be traced through batch number.  This facilitates checking the content of the drug through their batch number.

According to regulatory requirements each batch of a drug is given a unique identifying number which is written on the batch record . This is helpful in the entire manufacturing process and also in the packaging.When batch of a specific drug like capsule or tablet is finished, then all equipment used for the manufacturing must be cleaned as per the regulatory conditions.  This avoids any contamination in the manufacturing process of further products.

Batch number also helps checking the manufacturing and expiry dates of medicine. It also helps checking the prices of a drug as per the specific batch number and also if there are any  price changes.

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