Drug Volume Reporting: Industry 

Perspective

Ben Harpster August, 2022
About GSK

• GSK is a distributer and manufacturer.

• GSK distributes both prescription drugs and vaccines.

• GSK has 20 manufacturing sites that are involved in the 

supply to the U.S. market. Some of these sites are testing 

labs.

• GSK manufactures some of its own products as well as 

products for other companies. This includes:

– Pharma products

– Vaccine products

– OTC products
What to remember when reviewing a new 

guidance.
The Plan

Step 1: Identify scope/responsibility?

Step 2: Identify source(s) of information. 

Step 3: Collect and collate the data.

Step 4: Review and submit the reports.
Identify Scope/Responsibility

• Reporting to be done on all 

NDCs. This includes:

– Distributed NDCs

– Drug Product Manufacturer 

NDCs

– Drug Substance Manufacturer 

NDCs

• At GSK, we had all three types.
Identify Scope/Responsibility

• GSK reported for products 

manufactured at GSK 

manufacturing sites.

• Contract Manufacturers that 

manufacture our products would 

do their own reporting.

• We used “release” from the site 

of manufacture.
Identify Source(s) of Information

• Next step was to link the NDCs to

the material codes that identify

individual products in our resource

management software. In our case

this is the software SAP.

NDC

Material 

Code

• As reporting was to be done per

NDC, this meant that the Structured

Product Labeling (SPL) would be the

starting source of skus in scope.

These would be provided by the SPL

Subject Matter Expert (SME).
Identify Source(s) of Information

• Linking the NDCs to the material codes for marketed

skus.

– This was a manual process. We did track this

information already, just in a separate system.

• Linking the NDCs to the material codes for

manufacturer NDCs.

– This was a lengthy process as this took

cooperation between SPL SME and the site

planning departments.
Collect and Collate Data

• Once all material codes were identified, data was

extracted from SAP for the reporting period.

• With help from someone from our data analytics

groups, we were able to put calculations in a

spreadsheet to generate the data in the requested

format.
Collect and Collate Data

• Examples of items that would need calculations would

be:

– Bulks (both drug substance and drug product).

– Products that had multiple levels of packaging.

• Example of this would be a carton containing 10

vials.
Collect and Collate Data

• For Bulk Drug Substance/Drug Product, calculations

were a quandry.

– In SAP, the amount is tracked based on the yield

(kg for API and number of tablets for a drug product,

as examples).

– In the SPL, it is tracked by container

– Decision was made to add up the total yield of

batches per month, divide by the amount identified

in the SPL and round up.
Collect and Collate Data

• Simplified example of the

API bulk calculation:

– 2 batches in June,

both with a yield of

100 kg.

– In the drug listing, the

container (drum) is

identified as holding

10 kg.

– 200kg/10kg gives us

20 drums for June.
Review and Submit the Reports

• The collated data was reviewed by the SPL SME as 

well as each site’s logistics.

• Decision was made to submit the data one report for 

one site.

– We did see parsing errors.

– We did occasionally have the program crash when 

uploading.
Clarification Requests

• What would be FDA’s guidance/preference on how we 

calculate the drug substance numbers?

– How do we handle the calculation where the yield for 

a batch does not divide out exactly?

• 75kg yield/10kg drum =7.5 drums

– If we manufacture multiple batches in a month, do you 

want us to calculate each batch separately, or add 

them up and then calculate?

• 2 batches with 75kg yield.

– Combined:150kg/10kg= 15 drums

– Separate 75kg/10kg=7.5 drums (if you round 

up this would be 16 drums, and if you round 

down it would be 14 drums) 
Clarification Requests

• For marketed product, which “release” should we use 

to identify the site that reports?

– Site Release?

– Market Release?
Questions

• Currently, we are reporting on both the distributed 

NDCs and the Manufacturer NDCs. In essence, we 

are double reporting the same information. Would it 

not be more value added to report on the distributed 

NDCs?

• At some point, I expect that FDA will introduce some 

type of arrears list for companies that have not 

submitted. Has FDA given any thought on whom they 

will notify? Possibly the contact identified in the labeler 

code request?
Suggestions

• There has been a lot of discussion and confusion around whether 

sites that only package the finished marketed product are 

required to report. Clarification is needed on this topic. If they do 

need to report, consideration should be given to adding the 

“Label” business operation as it can represent the site where final 

packaging happened. 

• Include an example of a complex supply chain identifying who is 

responsible for reporting on the different NDCs that would be in 

place to support.

– An example of a complex supply chain is included on the next 

slide.

– The slide following that depicts the possible reporting 

responsibilities.
Example of Complex Supply Chain

• Product “Beta” is distributed by Company Z under the NDC 

9999-9999-99.

• API “Alpha” manufactured at Company A (NDC 1111-1111-

11/ 25 kg per drum)

• API “Alpha” manufactured at Company B (NDC 2222-2222-

22/ 35 kg per drum)

• Bulk Drug Product “Beta” manufactured at Company C 

(NDC 3333-3333-33/ 50,000 tablets per drum)

• Company D finish packs the bulk from Company C.

• Company E manufactures and packages the distributed 

product. Manufacturer NDC is 4444-4444-44.
Reporting for the Complex Supply Chain

• Company A would report on NDC 1111-1111-11

• Company B would report on NDC 2222-2222-22

• Company C would report on NDC 3333-3333-33

• Company D would report on NDC 9999-9999-99

• Company E would report on NDC 4444-4444-44 

and NDC 9999-9999-99

• Company Z would not have to report as the 

distributer.
Experience from a Smaller Pharma

Company
Smaller Pharma Process: Background and 

Groups Involved

• Specialty pharmaceutical company with large and small 

molecule drug applications

• Used release to market to define reporting numbers.

• Reported on any NDC that is contained in an SPL that 

they submit.

• Groups Involved

– Regulatory Publisher

– Regulatory Labeling

– Quality and Supply Chain

– Regulatory CMC
Smaller Pharma Process:Group’s

Responsibilities

• Regulatory Publisher

– Provided initial template and submitted the final result

• Regulatory Labeling

– Provided the list of skus in scope based on DUNS/NDC

– Developed the necessary calculations

– Provided product specific templates to appropriate Quality 

and Supply Chain contacts for batch release alignment.

• Quality and Supply Chain

– Populated Outermost Quantity Released by Month based on 

batch record review and SAP.

– Calculated innermost Quantity Released.

• Regulatory CMC

– Reviewed/verified completed template.
Smaller Pharma Feedback

• Problem Encountered:

– Companies had different intepretations on who should submit 

for this requirement.

• Suggestions for process:

– Remove the need to report on innermost.

– Template was very useful, but easily broken.

• Suggestions for Guidance:

– Eliminate the need to submit the distributer NDC info because 

the info will already be provided in the manufacturer’s 

submission. Would get rid of duplication.

– Provide additional clarity around:

• “agents” authorized by the manufacturer to submit on 

their behalf verses “FDA official authorized agent”.

• Manufacturer verses registrant.
SPL Process Team

• The SPL Process Team is a free volunteer industry 

group where we discuss and provide assistance for

SPL and related subjects.

• If you are interested in attending our monthly 

meetings, please reach out to our co-chairs and we 

will add you to our distribution list and forward the 

meeting invite.

– Benjamin.E.Harpster@gsk.com

– KCStevenson@ceuticallabs.com

– SKuhn@its.jnj.com

– Herbert.Obrien@bayer.com