PROSOLV®EASYtab SP (Brand name or equal) for the Albuquerque NM VA Cooperative Studies Program/ Clinical Research Pharmacy Coordinating Center (CSPCRPCC)

SOURCES SOUGHT
(PROSOLV EASYtab SP/brand name or equal)

The Albuquerque VA Medical Center at The VA Cooperative Studies Program (CSP) Clinical Manufacturing Section (CMS) has a requirement to purchase The Brand Name or Equal PROSOLV® EASYtab SP (Product) to make approximately 24,250,000 placebo tablets to support VA Cooperative Studies Program (CSP) Clinical Study CSP2002, Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT) .
This notice is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Monday, June 12, 2017, 12:00 Noon, EST. Interest/capability statements may be sent to Linda Buccigrossi at linda.buccigrossi@va.gov and should include company name, address, point of contact, socio-economic status and business size, and product information. No telephone responses will be accepted. This notice is to assist the Government in determining sources only. A solicitation is not currently available. If a solicitation is issued, all interested parties must respond to that solicitation announcement separately from the responses to this announcement.
***Email responses should include in the subject line PROSOLV® EASYtab SP

Type of Contract: Firm Fixed Price, Indefinite Delivery/Indefinite quantity

Deliver to: Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC)
VA CSPCRPCC
2401 Centre Avenue SE
Albuquerque, NM 87106
U.S.A.

Period of Peformance:


Period of Performance
8/1/ 2017 to 7/31/2018
8/1/ 2018 to 7/31/2019
8/1/ 2019 to 7/31/2020
8/1/ 2020 to 7/31/2021
8/1/ 2021 to 7/31/2022


See following for Statement of Work (SOW)/description of requirement


STATEMENT OF WORK (SOW)
PROSOLV®EASYtab SP (Brand name or equal)


CONTRACT TITLE.
PROSOLV®EASYtab SP


BACKGROUND.
The VA Cooperative Studies Program (CSP) Clinical Manufacturing Section (CMS) needs to make approximately 24,250,000 placebo tablets to support VA Cooperative Studies Program (CSP) Clinical Study CSP2002, Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT) .

The placebo tablet for CSP2002 must have essentially identical physical characteristics to the 500 mg extended release Metformin tablet we are matching for this clinical research study. We made pilot batches (i.e. conducted experiments) with a pre-blended product and with excipients the CMS would need to blend together appropriate for meeting the placebo tablet specifications of:

Weight,
Hardness (how difficult it is to break), and
Thickness.

The PROSOLV® EASYtab SP brand name or equal (Product) was chosen because the pilot batches showed that placebo tablets made with the product meet the specifications for weight, hardness and thickness and because use of the Product eliminates the 10,106 personnel hours required for CMS to blend excipients resulting in a significant cost saving to the government.


SCOPE.
The CSP Clinical Research Pharmacy Coordinating Center (CRPCC) is contemplating a firm fixed price, Indiefinate Delivery/Indefinate Quantity (IDIQ) contract of a base year plus 4 option year periods.

The IDIQ allows flexibility in the quantity of drums of Prosolv purchased each year based upon the projected study enrollment. The range for the minimum to maximum amount of Product expected to be purchased each year is defined in this notice.

The Product must:
Have a minimum expiration/re-evaluation date remaining of 2.5 years upon receipt,
Have a Certificate of Analysis supplied for each lot of product received by the CSP CRPCC, and
The manufacturer must have an active Drug Master File filed with the United States Food and Drug Administration for PROSOLV®EASYtab SP.
The Product must be Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathy (TSE) free.

REQUIREMENT:
Prosolv Easytab SP (Brand Name or Equal)
Sodium Starch Glycolate, Sodium Stearly Fumarate




ESTIMATED SCHEDULE OF SUPPLIES.



Product
Est Min Qty
Est Max
Qty


Period of Performance
Base Year
PROSOLV®EASYtab SP
150 KG
750 KG
8/1/ 2017 to 7/31/2018
Option Year 1
PROSOLV®EASYtab SP
150 KG
1650 KG
8/1/ 2018 to 7/31/2019
Option Year 2
PROSOLV®EASYtab SP
150 KG
3750 KG
8/1/ 2019 to 7/31/2020
Option Year 3
PROSOLV®EASYtab SP
150 KG
3750 KG
8/1/ 2020 to 7/31/2021
Option Year 4
PROSOLV®EASYtab SP
150 KG
6000 KG
8/1/ 2021 to 7/31/2022

SPECIFIC TASKS.

Task 1 Product
Provide the amount of Product designated yearly which shall not be less than the minimum or more than the maximum amounts stated in Item #3 above, Schedule of Supplies required by the CSP CRPCC. The Product will be provided in 25 Kg drums.

Where possible, each shipment shall consist of one lot or batch of product.

Subtask 1 Expiration Dating
The Product shall have a minimum expiration/re-evaluation date of two and one-half years (2.5) years upon receipt by the CSP/CRPCC.

Subtask 2 - Certificate of Analysis
The vendor shall assure that the product contains the following ingredients in the amounts indicated.
Ingredient
Function
Content
Regulatory Requirement
Microcrystalline Cellulose
CAS No. 9004-34-6
Binder/ Filler
95 - 98%
NF, Ph. Eur., JP
Sodium Starch Glycolate
CAS No. 9063-38-1
Superdisintegrant
1.2%
NF, Ph. Eur., JP
Colloidal Silicon Dioxide
CAS No. 112945-52-5
Glidant
1.5 2.5%
NF, Ph. Eur., JP
Sodium Stearyl Fumarate
CAS No. 4070-80-8
Lubricant
0.3 1.0%
NF, Ph. Eur., JP
The vendor shall provide a Certificate of Analysis showing the Product meets its specifications for each lot or batch of Product delivered to the CSP CRPCC.

Parameter
Acceptance Criterial
Reference
Identification I Microcrystalline cellulose
Violet Blue Color
NF, Ph. Eur., JP
Identification II Microcrystalline cellulose
Stable suspension
JP
Identification III Microcrystalline cellulose
Degree of polymerization NF, Ph. Eur., JP
Identification IV Sodium Starch Glycolate
Blue or violet color
NF, Ph. Eur., JP
Identification V Sodium Stearyl Fumarate
0.3 1.0%
JRS Method
Identification VI Colloidal Silicon Dioxide
Yellow Color
NF



Assay Sodium Starch Glycolate
0.5 2.0%
JRS Method
Heavy metals
NMT 20ppm
JRS Method
Loss on drying
NMT 7.0%
USP, Ph. Eur., JP
pH
6.0 8.0
USP, Ph. Eur., JP
Residue on ignition (Assay Colloidal Silicon Dioxide)
1.5 2.5%
USP, Ph. Eur., JP



Total Aerobic Microbial Count
103 cfu/g
USP, Ph. Eur., JP
Total Yeast and Mold Count
102 cfu/g
USP, Ph. Eur., JP
Escherichia coli
Absent in 1 g
USP, Ph. Eur., JP
Pseudomonas aeruginosa
Absent in 1 g
USP, Ph. Eur., JP
Salmonella species
Absent in 10 g
USP, Ph. Eur., JP
Staphylococcus aureus
Absent in 1 g
USP, Ph. Eur., JP



Bulk Density (g/ml)
0.30 0.42
NF, JP
Degree of brightness
Min. 87%
JRS Method
Particle size (retained on air jet sieve)
> #60 mesh sieve (250 µm)
> #200 mesh sieve (75 µm)

Max. 8%
45 80%
JRS Method
Particle size (laser diffraction)
D10
D50
D90

25 50 µm
90 150 µm
190 300 µm
JRS Method
Powder Flow - Angle of Repose (°)
Max. 38°
JRS Method


The raw materials, manufacturing process and product shall not contain any of the solvents listed in the Residual Solvents (USP , Ph. Eur. ) except toluene, ethanol and acetone.

Residual Class 2 solvents toluene and ethanol shall be below Option 1 limit and residual Class 3 solvent acetone shall be below 0.5 per cent.

Subtask 3 - Drug Master File

The vendor must have an active Drug Master File (28461) filed with the United States Food and Drug Administration for PROSOLV®EASYtab SP. The vendor will provide the CSP CRPCC with notifications of changes to the manufacturing process that may impact the Product.

Subtask 4 - TSE/BSE Free

The Product must be Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathy (TSE) free.

PERFORMANCE MONITORING.

The CSP CRPCC will monitor performance upon product delivery by:

Statements
Standards/AQLs
Inspections
Methods
Identification testing on each lot of product received
FT-IR: The sample is positive for microcrystalline cellulose if the software matches it to microcrystalline cellulose
Or
FT-NIR: Positive for Microcrystalline Cellulose if the match value is 90.00 or greater
Laboratory Analysis
FT-IR







FT-NIR
Reviewing each Certificate of Analysis (CofA) to assure the product meets the vendor s specifications
See the attached example of a JRS Pharma CofA for Product
Review CofA
Direct Observation




OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS.

Identification of Possible Follow-on Work.

CSP2002 is expected to last a minimum of seven years. Because of the large tablet requirement, we will need to continue ordering the same Product to supply tablets for the length of the study.

Information on the clinical study is reported to the Food and Drug Administration (FDA). FDA expects the CSP CRPCC to use the same Product for the life of the study because changing the Product might influence the outcome of the trial.

Identification of Potential Conflicts of Interest (COI).

No organizational COI exists.

Identification of Non-Disclosure Requirements.

The contractor will not have access to sensitive or proprietary information.

Packaging, Packing and Shipping Instructions.

Product shall be shipped from the vendor to the attention of:

Jan Hickey
VA CSPCRPCC
2401 Centre Avenue SE
Albuquerque, NM 87106
U.S.A.

Product shall be shipped in appropriate containers to prevent contamination, degradation or shipping damage.

Inspection and Acceptance Criteria.

The CSP CRPCC will:
Inspect each shipment for damage upon receipt,
Sample each shipment and conduct identification testing to assure the appropriate Product is received.
Review the Certificate of Analysis to assure the Product meets its specifications.

RISK CONTROL.

The CSPCRPCC will minimize risk to Veteran patients taking placebo tablets manufactured using the Product by:
Testing each lot of placebo tablets manufactured using this product to assure it meets the in-process and finished placebo tablet specifications.
Entering all process and product deviations, out of specification results, etc. into our Corrective and Preventive Action (CAPA) system, reviewing and correcting these items, documenting all changes appropriately and completing other actions as required to assure the Product is safe.


DELIVERY SCHEDULE.
Deliverable Title
Format
Number
Calendar Days After Start
PROSOLV® EASYtab SP
25 kg drums, 6 drums to a pallet

Minimum 3 year retest/ expiration

Each lot of Product shall have a Certificate of Analysis

Varies
24