Pharma Serialization Update - April

Bill Fletcher highlights a few key deadlines looming for Pharma Serialization:

1. The FDA enforcement discretion not to enforce the transaction document aspects of the Drug Supply Chain Security Act (DSCSA) ends May 1. Companies who may have chosen to spend more time working out kinks in their transaction document (TD) may be running out of time.  
2. There is controversy with the way shipper cases are tracked in Brazil.
3. Companies selling into Brazil will now need to collect traceability data from 3 LOTs by December of this year. 
4. Chinese traceability is fully effective this December.  
5. New requirements in India for primary packages are creating very onerous designs on manufacturers
6. EU delegated acts for Falsified Medicines is expected in the next couple of months. Encoding will include GTIN, country reimbursement code, LOT expiration date and serial number in human readable and encoded in a GS1 DataMatrix symbol

Bill Fletcher - Pharma-Logic

India’s Pharma Export Regulations Update And The NECC Story

India’s Pharma Export Regulations Update And The NECC Story - By Dirk Rodgers of RxTrace.com
I was more than a little disappointed when I saw that SecuringIndustry.com had beaten me in a race to publish an essay/article about the new crazy serialization and traceability requirements published last week by the government of India.  That was to be my topic for next Monday.  But after reading their excellent coverage—received just as I was sitting down to begin writing—I felt better.  At least I had not yet started writing!  Don’t miss Phil Taylor’s excellent coverage and his link to the source regulation.  See if you agree how crazy it is. View full article here

Saptac : Benefits of Supplier Relationship Management

It is often seen that companies focus on maintaining and improving their relationship with the customers. Fostering customer loyalty has become the prime goal of the business organizations but while doing so, there is a dire need to ensure that the relationship with suppliers doesn’t get neglected. A good relationship with the suppliers is equally […]


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