Basics Of Pharmacy: Work Instructions In Pharma

Tuesday, November 30, 2021

Work Instructions In Pharma

As the name indicates, work instructions are the written instructions to complete a specific task in an area and if we talk about pharmaceutical industries then work instructions are written instructions to show how a specific work is to be performed during the manufacturing or cleaning process.

Importance Of Work Instructions

  • As we know that working in pharmaceutical industries involves very sensitive procedures so these procedures should be carried out with great care and accuracy.

  • Standard Operating Procedures are written for every equipment and processes and are followed,but these may be written in a little bit complex language so we use work instructions as well.

  • Work Instructions are simple and are written in such a way that it can easily be understood by the workers and operators as well.

  • Work instructions include details of instruction and should only contain information related to one specific process.

  • All the data added in work instructions should be to the point and readable.

  • In general practice, the procedures are explained by the old workers to the new one but there may be some manipulation during the explanation.

  • So work instructions are written 

in such a way that every new one can easily follow the written instructions.

  • The flow charts can be added during the writing of work instructions.

  • Work instruction can be written in the native language for better understanding.

  • If work instructions are written in English, always use simple and easy words.

  • Work Instructions are hung in an area where work is to be performed and are visible to the operator and workers.

  • Work instructions should be approved by the production and quality assurance head.

  • If there is any change in the procedure, it should also be mentioned in the work instruction sheet.


Take the example of work instructions for wet

granulation operation.

Work instruction should be written in following,

  • Take an approved Batch Manufacturing Record(BMR)

  • Take line clearance before starting the granulation process.

  • Weigh all the ingredients mentioned in BMR and sieve through the mesh mentioned in the batch manufacturing record.

  • Add all the sieved materials into the granulation mixer and operate according to the parameters mentioned in BMR.

  • After completion of the kneading process, sieve the wet mass through the wet mill.

  • Dry the granules in dyer at the parameters mentioned in the BMR.

  • After completion of drying time check the moisture contents of the granules.

  • If the moisture content is within range as mentioned in the batch manufacturing record, remove the granules and weigh them.

  • Calculate line loss and record yield of dry granules in the batch manufacturing record.

  • Now install the sieve in a granulator or dry mill mentioned in the batch manufacturing record and screen the dry granules.

  • Sieve all the remaining ingredients according to BMR, which are to be used in final blending.

  • Add dry granules in the blender and mix with ingredients as mentioned in the batch manufacturing record.

  • Add lubricants at the end and do not over mix.

  • Remove the final blend in containers and weigh it.

  • Calculate the line loss and record the final yield in the batch manufacturing record 

  • Tightly close all the containers and store them in the storage area according to SOP.

Also Read:

What Is Quality Assurance

Ginger and Constituents Of Ginger

Clove and Its Constituents

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