What is GxP?

In this Post we will look in to the GxP. This is common term as part of the compliance if we are working in any Life sciences industry.

What is GxP?

GxP is a group of compliance that the particular industry should adopt as part of the industrial / audit compliance.

G- Stands for Good
x- is  Kind of Variable.
P-stands for Practice

we will see in detail few of the X- which the life science industry adapts.


Good Manufacturing Practice:

This process details the manufacturing process and also the process that are followed to eliminate the Risk.The industry need to adopt/ publish the quality standards that it will be following.It also describes the minimum deviation.  for more info

Good Laboratory Practice.

This process details and defines the quality system for the laboratory. This applies to non clinical studies.One of the core objectives is to ensure and promote the safety and reliablility of chemical in non-clinical and laboratory testing. ..read more

Good Documentation Practice:

This process defines the standards on which the documents are created,stored and retrieved in the complete life cycle of the process.It needs to have permanent traceable records.for more info

Good Clinical Practice.

This practice  defines on the process defined to conduct the clinical trial on the human bodies.High standards are required for clinical protocol. Read more

Production Planning Process Flow

I like to explain the Production Process flow for a simple demand to stock cycle.
1.1.Create a demand in the md61 transaction for a plan and material combination.
This has to be maintained for the Finished goods material only ie) which has a BOM and a routing.
1.2.Here ensure that the version check box is selected ,becoz only if it is selected it will be considered for MRP Run.

Step2:Run MRP
2.1.Now using the transactin Md02 give the same material and plant and run the MRP.
2.2 In the MD02 screen the Planning Paremeters are to be selected accordingly.
2.3 Execute the transaction.

Step3:MD04 stock requirement List
3.1.Now you can use the Md04 transaction to view the Demand created by Us and also the proposal generated by the system if there is shortage of supply for the demand.
3.2. System generats Planned order.
3.3. Double click on the planned order no , which will help us to convert the planned order into an production order.
3.4 Now you can create the Production order.
3.4 In the same step you can release and save the order.
3.5 Now in the Md04 screen on refresh we can view the Production order number on display.

step4: Production order
4.1. Using Co02 we can view the status and also the BOM,Routing etc that has been copied from the master data to the production order.

Step5: Production order confirmation.

5.1. Using CO11N confirm the Production order operations.
5.2. To avoid any error in the stock posting we should confirm the production for the previous operations or order which will be increase the stock of the finished goods.Also the required purchase material stock is also to be checked.
5.3. During the production confirmation of the final operation we can view the goods movements of the material produced and also the material consumed.
5.4. execute and save the transaction.

Step6: GR/GI check
6.1 now we can check the goodrecevied and also goods issued with different transactions
6.2 Co03 – in this you can use the Documented goods movement to view .
6.3 MB51-Material document list.
6.4.Coois – Order information list.