SAP OTC specifics for pharmacy companies

[Former Member]

Hello everyone

I am a SD/MM consultant and have worked for manufacturing & professional services companies in my career.

Currently I have been selected to work on a project for a pharma company and I have some basic doubts:

- I know that pharma companies have to follow certain compliance/regulations.

Does this impact/modify the standard SAP SD OTC and MM P2P Business processes ? (In short - how are these 2 processes different from an SAP implementation for a manufacturing company).

- Our client has mentioned that - prior experience of a pharma company is preferred.

Hence I want to know "what regulations/compliance information or any other important information knowledge is expected from a SAP SD/MM consultant" 

I want to get as much information as possible before being deployed at a pharma client.

Hence I require some input from you guys.

Please let me know your thoughts.

Thanks for your time.

- Vin

[Lakshmipathi · Accepted solution]

The basic pre-requisite to handle pharma industry in SAP is you should have knowledge in Batch Management.  This will take care of whatever regulations you were referring.

G. Lakshmipathi

[Former Member · Accepted solution]

Hi Lakshmipathi

Thanks for your input.

I have worked on Batch Management in manufacturing. How different is it from pharma ?

Also - could you tell me what are the generally used compliance/regulations used in pharma clients if you have an idea ?

Thanks

Vin

[Lakshmipathi · Accepted solution]

SAP has not provided anything specific to Pharma.  You have to go with standard Batch Management.  Coming to your query on difference between manufacturing and pharma, in manufacturing, there wont be any product that has Shelf Life Expiration Date (SLED) but in pharma, it is predominently being followed.  May be if you Google it on this topic, you will get lot of documentations which would help you.

G. Lakshmipathi

[Lakshmipathi · Accepted solution]

A Standard Building Block on Batch Management for Pharma is there.  As I already said, just search in Google.

G. Lakshmipathi

[former_member182575 · Accepted solution]

There is also SAP's new tracking functionality that you could review.

Hope it helps.

Waza

[Former Member]

I was very briefly associated with a Pharma company. I am not sure if you would be responsible for complete life cycle implementation or just configuration. Because pharma company have to follow strong FDA guidelines, "testing" is very crucial. A lot of time is invested in the Testing phase. So may be you would want to hone your testing skills as well before joining the project..

Sham

[phanikumar_v3]

Adding to above you should also be aware of Listing/Exclusion(some drugs cannot be salable to all the Retailers)

also a little knowledge on total quantity that is allowed for retailers in specific period.

(because some retailers are not allowed to purchase more than some specific quantity like CNS depresent drugs which is useful in treating all psychological disorders)

Also you need to understand Returnable Packaging too(some times some drugs can be sent to Retailers along with the packing facilities which will maintain the temperature between 2 to 8 degree Celsius (normally customer returns these once after receiving goods)

Phanikumar

[swapnilkelkar]

Hi Vinit

From Pharma Perspective , the solution in SAP should have below things

1. As Already mentioned Batch Management is Key. I would like to add along with batch management , the batch release process along with certificates related to Batches plays a key role.

2. Generally in pharma we have Make to order process , so it would be good to know about standard MTO flow .

3. Another key aspect is Subcontracting process. Each Pharma company has its own subcontracting process defined but its one of the critical processes in Pharma industry.

4. Planning with MRP also is important from the system set up .

Hope this helps

Regards

Swapnil