Validation of Equipment – Pharma Industry

The concept of validation was first developed for equipment and processes. In 1993 the software for a large radiotherapy device was not designed and tested properly. Several problems resulted in several devices giving doses of radiation higher than intended. Because of that several patients died and several got permanently injured. That is why validation of equipment is required for pharma industry. Following are the steps followed to do validation of equipment in SAP and how to create link between maintenance order and calibration order.
Validation of Equipment after Corrective Maintenance by QC in SAP.
  1. When Equipment Breakdown is reported by Production, Maintenance Person gets a break down order. He attends the Breakdown through Breakdown order.
  2. After solving the issue Maintenance person submit the Equipment to Production for check/dry run
  3. Then Production person will raise a Request for Validation to Quality department.
  4. Quality person will validate the Equipment through calibration order. They will check all the parameters, Room Temperature, humidity & also the parts replaced by maintenance etc. according to details mentioned in the Maintenance order.
  5. After completion quality person will revert back to Production, Production gives approval to close the Maintenance order.
  6. To create link in SAP between Maintenance order and Calibration order, you can use suborder concept.
In SAP create a maintenance order PM01 for break down, and then create a calibration order PM05 as sub order (IW36). You can settle the sub order to a different cost center, so that calibration order cost is settled to Quality department.
nchitre Validation of Equipment – Pharma Industry
Nikita Chitre

ArchitectSAP Solutions
SAP. Streamlined.

16 comments:

ravi said...

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pharmaceutical equipment

ravi said...

warm Greeting


These kind of post are always inspiring and I prefer to read quality content so
I happy to find many good point here in the post, writing is simply great, thank you for the blog.




pharmaceutical equipment

dasbiswajite said...

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mithun12 said...

We can then execute the protocols, analyse and interpret the data collected, resolve any deviations noted during the execution, and prepare final validation reports.Qualification and Validation are integral steps in Quality by Design, building quality into any process or facility.

Bikram ku das said...

Standard person can validate the Equipment through calibration order. They will check every the parameters, Place Heat, humidity & additionally the components changed by maintenance and others. based on information discussed inside the Upkeep purchase.automateandvalidate

jackbroobgm said...

We can then execute the protocols, analyse and interpret the data collected,
resolve any deviations noted during the execution, and prepare final validation reports.
building quality into any process or facility.


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Kevin Petter said...

Any single group must be subjected to the 3 validation cleaning requirement,
except if a rationale is recorded and also approved by the Standard Authority
which the worst-case product of one group is clearly a worst-case product for every one of the groups.
Software validation is a part of the design validation for a finished device,
but is not separately defined in the Quality System regulation.


equipment validation

Andree Symond said...


Validation has become one of the pharmaceutical industry’s most recognized and discussed subjects.
It is a critical success factor in product approval and ongoing commercialization.
This article provide brief introduction about the pharmaceutical process validation and its importance according to regulatory provision,
also provide the answer of question like why to do, when to do and how to do it.
This work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process.
Quality is always an imperative prerequisite when we consider any product.



equipment validation

Andree Symond said...

we have probably seen the equipment before.
Our consultants will use their experience from many sites to ensure that critical to quality parameters are considered during this process.
We've seen what works and what definitely doesn't.

equipment validation

Devid Woody said...

Standard person can validate the Equipment through calibration order.
They will check every the parameters,
Place Heat,humidity & additionally the components changed by maintenance and others.
writing is simply great,thank you for the blog.

equipment validation

Alexis Texes said...

You are faith on mordern software ,please contact :-The Validation Software solution article is clearly stating the new software validation process that can work in the favor and help in making the run for any Validation Change Management money. There are different tools and software’s which are enhanced and come with Validation Software abilities making it very true in the present market. For instance the new condition of all works which is happening in the software industry is Electronic Validation quite similar.

Lavies Dammp said...


Focuses on the validation of laboratory equipments used in the production of pharmaceutical products.
Determination the requirements of the end user,
which are often defined in the User Requirements Specifications.equipment validation is a part of the design validation for a finished device,
but is not separately defined in the Quality System regulation.

equipment validation

williams paul said...

The well-known tools and greater management validation process :-
The best of Equipment Log Management facts and the software tools which are coming of age make way for the things that are necessary to have Paperless validation. The order and new languages are all meant to serve the purpose in best new ways as best thing about the life. The Risk Based Validation Meteor basically depends on jQuery. The tool can Equipment Validation be used in the process of the help of JavaScript UI library.

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