Pharma_Logic

Our mission: patient safety through a secure supply chain in life sciences. Our services include complying with traceability, serialization, DSCSA, DQSA, UDI.

[Pharma_Logic @pharma_logic]

During @HDAconnect #Traceability2019 day 2, the #HDA legal panel provided valuable information on implementation of #DQSA, #DSCSA, & verification (#DSCSAVRS).

Our subject matter experts can help you avoid issues, risks and audit your proper compliance.

[email protected]

[Pharma_Logic @pharma_logic]

@HDAconnect

During the #HDA #Traceability2019, Peter Sturtevant, @GS1_US confirmed that #DQSA #DSCSA partial case label recommendations are under review to include NDC in symbol.

Our Certified GS1 Professionals can help you adopt proper label layouts. [email protected]

[Pharma_Logic @pharma_logic]

@HDAconnect #DQSA #DSCSA

The #HDA #Traceability2019 event kicks off day 2 with Peter Sturtevant, GS1 US and discussion about barcode and data standards and recent adoption.

Our Certified GS1 Professionals can help you avoid issues and audit current use. [email protected]

[Pharma_Logic @pharma_logic]

@HDAconnect @US_FDA #DSCSA #DSCSAVRS

The need to ensure quality barcodes is EXTREMELY IMPORTANT was emphasized many times during #HDA #Traceability2019.

Does your company grade barcodes for each batch?

We have helped simplify this for many companies. [email protected]

[Pharma_Logic @pharma_logic]

@HDAconnect @US_FDA #HDA #Traceability2019 #DSCSA #DSCSAVRS

During the HDA legal panel discussion, they emphasized the FDA enforcement delay does not change the Manufacturer's requirement to verify SN today!

Are you sure you are ready? We can help. [email protected]

[Pharma_Logic @pharma_logic]

@HDAconnect @US_FDA #HDA #Traceability2019 #DSCSA #DSCSAVRS

The HDA industry panel on verification of drug products stated that companies must ensure ALL of their serial numbers are in their VRS system.

We have helped audit SN compliance for many. [email protected]

[Pharma_Logic @pharma_logic]

@HDAconnect @US_FDA #HDA #Traceability2019 #DSCSA #DSCSAVRS

During the HDA Traceability meeting, an industry panel discussed challenges associated with complying with verification for returned products that will be resold.

Is your organization ready? [email protected]

[Pharma_Logic @pharma_logic]

@HDAconnect @US_FDA #HDA #Traceability2019 #DSCSA #DSCSAVRS

HDA legal panel emphasized the need to have SOP in place and followed to avoid enforcement actions.

An independent subject matter export can audit your compliance and prevent issues.

Write [email protected]

[Pharma_Logic @pharma_logic]

@HDAconnect @US_FDA #HDA #Traceability2019 #DSCSA #DSCSAVRS

HDA legal panel clarified that verification failure means the product MUST be TREATED as SUSPECT.

Are you sure your current project addresses all areas of the law and not just technical? Write [email protected]

[Pharma_Logic @pharma_logic]

@HDAconnect @US_FDA #HDA #Traceability2019 #DSCSA #DSCSAVRS

The HDA legal panel discussed the DSCSA and DQSA law and pilot projects being conducted by the FDA.

A subject matter export who is not selling solutions can cut through confusion. Write [email protected]

[Pharma_Logic @pharma_logic]

@HDAconnect @US_FDA #HDA #Traceability2019 #DSCSA #DSCSAVRS

FDA presented the work they are doing to clarify issues relating to how an unverified product or verification error should trigger suspect investigations.

Are you ready? Independent review by [email protected].

[Pharma_Logic @pharma_logic]

@HDAconnect @US_FDA #HDA #Traceability2019 #DSCSA #DSCSAVRS

FDA presented important updates on the barcode and product identifier, including clarifying the GTIN CANNOT be substituted for the National Drug Code (NDC).

NDC is human readable and symbol required on CASE and UNIT.

[Pharma_Logic @pharma_logic]

@HDAconnect @US_FDA #HDA #Traceability2019 #DSCSA #DSCSAVRS

Connie Jung, RPh, Sr Advisor for Policy, U.S. Food and Drug Administration (FDA) presents updates on the FDA activities around supply chain security in life sciences and drug distribution, including DQSA / DSCSA law.

[Pharma_Logic @pharma_logic]

@HDAconnect @US_FDA #HDA #Traceability2019 #DSCSA #DSCSAVRS

The Healthcare Distribution Alliance (HDA) annual traceability meeting is off to a great start. Perry Fri, Executive Vice President and COO presents many important details about industry activities.

[Pharma_Logic @pharma_logic]

@HDAconnect @US_FDA #HDA #Traceability2019 #DSCSA #DSCSAVRS

During the Healthcare Distribution Alliance (HDA) Verification Router Service (VRS) meeting, several concerns with readiness were discussed, including but not limited to verifying that all SN data is in production.

[Pharma_Logic @pharma_logic]

@HDAconnect @US_FDA #HDA #Traceability2019 #DSCSA #DSCSAVRS

Healthcare Distribution Alliance (HDA) Verification Router Service (VRS) meeting is focused on coordination and collaboration to facilitate testing across the various solutions and solution providers.

[Pharma_Logic @pharma_logic]

@HDAconnect @DEAHQ #DQSA #DSCSA #HDA #Traceability2019 #DSCSAVRS @US_FDA

If a manufacturer receives a verification request and cannot positively verify the product, does their awareness of unverified product trigger the response to notification requirements? Has your legal staff evaluated risk?

[Pharma_Logic @pharma_logic]

@HDAconnect @DEAHQ #DQSA #FDA #HDA @HDAconnect #Traceability2019 #DSCSAVRS @US_FDA

The manufacturer must perform a suspect product investigation as defined under § 360eee–1(b)(4)(A) following a failed VRS requests.

[Pharma_Logic @pharma_logic]

@HDAconnect @DEAHQ @HDAconnect @US_FDA #DQSA #FDA #HDA #Traceability2019 #DSCSAVRS

Under U.S. Code, Title 21, Chapter 9, Subchapter V, § 360eee–1(b)(4)(B) (iii), a manufacturer must respond to a notification from a trading partner that it has an illegitimate product. Is a failed #VRS notice?

[Pharma_Logic @pharma_logic]

@HDAconnect @DEAHQ #DQSA #FDA #HDA @HDAconnect #Traceability2019 #DSCSAVRS @US_FDA

Although enforcement of verification has been delayed, the response to the notification requirement has not changed.

Under the #DSCSA, a manufacturer must still respond to a verification from a trading partner.