Table of Contents - Baxter, BioPharma Solutions...BioPharma Solutions Product Questionnaire Page 1...

of 19BioPharma Solutions Product QuestionnaireBioPharma Solutions Product Questionnaire

Product QuestionnaireLet us help you find the SOLUTION for your product needs

This product questionnaire has been designed to help you initiate a successful transfer of your product/process to an appropriate Baxter manufacturing facility.

Please fill out the applicable sections for your project.

Table of Contents

Contact Information .........................................................................2Product Information .........................................................................3

Identification and Description ......................................................3Active Pharmaceutical Ingredient (API) .......................................5Additional Ingredients or Solvents (i.e., Excluding API) ..............6Process ........................................................................................7

Compounding ...........................................................................7Bulk Material and Final Product Compatibility ..........................7Sterile Filtration .........................................................................8Formulated Product ..................................................................8Filling .........................................................................................9Lyophilization ............................................................................9Final Sterilization .......................................................................9Cleaning Validation ...................................................................10Storage, Handling, and Shipping Conditions ...........................10Additional Process Information .................................................10

Analytical Testing .........................................................................11Incoming Active Pharmaceutical Ingredient (API) ....................11Drug Product in Process Control ..............................................11Drug Product Release ...............................................................11Method(s) ..................................................................................12Stability .....................................................................................12

Primary Packaging ..........................................................................13Vial ............................................................................................13Stopper (Vials) ..........................................................................13Seal ...........................................................................................14Syringe ......................................................................................14Plunger/Stopper (Syringes) ......................................................15Plunger Rod ..............................................................................15Cartridge ...................................................................................15Plunger/Stopper (Cartridges) ...................................................16Combi Seal ...............................................................................16

Secondary Packaging and Inspection ............................................17Additional Environmental Health and Safety (EHS) Information ......18

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Contact Information

Company Name and Address

Primary Contact

Secondary Contact

Company name:

Address:

City:

State:

Zip:

Country:

Web site:

Last name:

First name:

Department/title:

Phone:

Fax:

E-mail:

Last name:

First name:

Department/title:

Phone:

Fax:

E-mail:

Date:


FDA application status: IND PLA NDA ANDA PMA Other:

FDA application registration number:

What is the intended use for this product? Preclinical Studies Cl Phase I Cl Phase II Cl Phase III Commercial

Where are the clinical studies performed? USA Japan Europe Other:

What are the target markets? USA Japan Europe Other:

Product name:

Generic name:

Formulation strength(s):

Attachment: Please attach Material Safety Data Sheet (MSDS) and/or Toxicology Studies, Investigational Brochure, Safebridge Assessment.

Estimated market launch date:

Annual units:

Proposed batch size:

Project start date:

When are the first batches required?

Product type: Liquid Lyophilizate Powder Sterile crystallizate Suspension/Emulsion

Product indication:

Application/Use:

Product InformationIdentification and Description

Identification

Timeline

Forecast

Description

Regulatory Requirements


Forecast (continued)

First year:

Comment:

Second year:

Comment:

Third year:

Comment:

Fourth year:

Comment:

Fifth year:

Comment:

Identification and Description (continued)


API name:

Chemical name:

Chemical abstract number:

Exposure limit/Band: OEL: /m3 or OEB (Occupational Exposure Band): class /4

For additional information, please refer to the chart on page 18.

API cost: per

Is API sterile? Yes No

API container size:

API container type:

Physical properties: Liquid Solid Frozen Density: g/mL

Hygroscopic? Yes No

Electrostatically chargeable? Yes No

Inert atmosphere required? Yes No

Inert gas used:

Light sensitive? Yes No

Critical wavelength:

Temperature sensitive? Yes No

API storage temperature:

Maximum exposure time at room temperature (RT):

Comments:

Active Pharmaceutical Ingredient (API)

Identification

General

Physical Properties

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PDE (Permitted Daily Exposure) / ADE (Acceptable Daily Exposure) value:

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μg/day

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Name:

Quality/Grade: EP USP JP Other:

Supplier (if a special one is required):

Name:



Name:



Name:



Name:



Name:



Additional Ingredients or Solvents (i.e., Excluding API)

Ingredient/Solvent 1







Bulk Material and Final Product Compatibility

Process

We assume that your product is compatible with

stainless steel (316L), glass, nylon, silicone,

polycarbonate, polysulfate, PE, PP, PTFE, and EPDM.

If your product is not compatible with these

materials, please specify:

Compounding

Compounding takes place in: Stainless steel vessel Glass vessel Disposable bag (polyethylene)

Compounding solution:Name of Ingredient/Solvent Concentration in bulk

solution [mg/mL] Function

Batch size (L):

Viscosity (cps):

Density (g/mL):

pH range:

Temperature range (°C):

Bulk solution holding time (h):

Can the product be formulated one day prior to filling? Yes No

Attachment: Please attach a compounding process description document.

All excipients are USP grade? NoYes


Process (continued)

Formulated Product

Is an inert atmosphere required? Yes No

Gas used:

Light sensitive? Yes No

Critical wavelength:

Shear sensitive? Yes No

Moisture sensitive? Yes No

Temperature sensitive? Yes No

Maximum exposure time at room temperature:

Please list any stability issues related to this product

(e.g., freeze-thaw sensitive, protein aggregation):

Sterile Filtration

Aseptic filling: Yes No

Filter for pre-filtration: Millipore Pall Sartorius Other supplier:

Filter type:

Pore size (μm):

Catalogue number:

Is this filter validated? Yes No

Filter for sterile filtration: Millipore Pall Sartorius Other supplier:

Filter type:

Pore size (μm):

Catalogue number:

Is this filter validated? Yes No


Process (continued)

Final Sterilization

Terminal sterilization: Yes No

Terminal sterilization method: Steam Other

If other, please describe (irradiated products can be

shipped to a contract sterilization facility, if required):

Lyophilization

Cycle time (h):

Minimum shelf temperature (°C):

Maximum shelf temperature (°C):

Maximum cooling rate (°C/min):

Maximum heating rate (°C/min):

Minimum vacuum:

Shelf temperature during loading (°C):

Collapse temperature (°C):

Target residual moisture (%):

Unloading temperature (°C):

Reconstitution volume (mL):

Reconstitution solvent:

Attachment: Please attach a lyophilization cycle document.

Filling

Target fill volume (mL):

Upper/lower warning limit (+/- mL):

Upper/lower action limit (+/- mL):

Filling temperature (°C):

Nitrogen flushing: Yes No

Time limit for filling (h):

Time limit for units at room temperature (h):


Cleaning Validation

Storage, Handling, and Shipping Conditions

List the LD50 value and the animal species tested

(e.g., IV mouse):

Route of application:

Normal therapeutic dosage:

Minimum daily dose:

Maximum daily dose:

Solubility in water (mg/mL):

Solubility in ethanol (mg/mL):

Solubility in isopropanol (mg/mL):

Data for other solvents:

Labeling and packaging (°C):

Drug product storage (°C):

Shipping (°C):

Additional Process Information

Please provide us with the specific process

needs for your product.

Attachment: Please attach executed batch record or process flow diagram.

Process (continued)


Only mark the tests that need to be performed by Baxter.

Indicate if the method needs to be validated/transferred:

Specification attached Identity by:

Specification TBD

Appearance Purity by:

pH

Color Assay by:

Clarity of solution



Appearance Concentration/Assay pre-filtration by:

pH bulk solution (pre-filtration)

pH bulk solution (post-filtration) Concentration/Assay post-filtration by:

Endotoxins of compounding solution

�Microbial purity of compounding solution Other (please specify):

��Endotoxins of bulk solution to sterile filtration

��Bioburden of bulk solution prior to Other (please specify):sterile filtration

Comments:

Validation�Transfer




Analytical Testing

Incoming Active Pharmaceutical Ingredient (API)Only mark the tests that need to be performed by Baxter.

Drug Product in Process Control

Active Pharmaceutical Ingredient (API): Specification attached Specification TBD

Test according to: EP USP JP Company supplied methodology

ID testing method: IR UV HPLC GC Other:

If other, please specify: Validation of analytical method Transfer of analytical method

Satellite sample included: Yes No

Additional information:

Drug Product Release





Analytical Testing (continued)

Does Baxter need to perform stability studies? Yes No

Standard testing duration (months): 12 24 36 48 60 Other:

Which climatic zones should be covered? I II III IV Other:

Accelerated testing duration (months): 3 6 12 18 Other:

Under which conditions?

Has an expiration date been established for this product? Yes No

If yes, please describe:

Additional comments:

Attachment: Please attach a stability program document.



Other (please specify):



Comments:

Drug Product Release (continued)

Stability

Validation

Visual particles

Validation

W�ater content (Karl Fischer)T�ransfer

Particulate matterSub-visual particles

Residual solventsTr�ansfer

Bacterial Endotoxin Test (Must be validated by Baxter on 3 product batches)




�Test for Sterility (Must be validatedby Baxter on 3 product batches)

Method(s)

Please describe or attach a copy of

analytical method(s):

Attachment: Please attach a copy of analytical method(s).


Size: ��DIN ISO US Format Other:

Catalogue number:

Supplier:

Glass (USP Type I, II, or III):

Type: Molded Tubing Flint (clear) Amber Untreated

SO2 treated (tubing only) Other:

Certificate according to: EP USP JP

Comments/special requirements:

Vial opening: 13 mm 20 mm Other:

Blowback feature: Yes No

Attachment: Please attach a drawing, specification, or certificate document.

Formulation:

Mold number:

Coating:

Type:

Supplier:

Contact:

Pre-siliconized: Yes No

Silicone level (if applicable):


Silicone treatment may be required for optimal seating of

the stopper. Is silicone treatment of the stoppers permitted?

Yes No


Primary Packaging

Vial

Stopper (Vials)

BioPharma Solutions is prepared to support you with the packaging needs for your specific product:

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Please include any cleanliness or particle load specifications for any RTS and RTU components.

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Syringe

Size:

Catalogue number:

Supplier:

Glass/Polymer:

Nest configuration:

Baked silicone: Yes No

Tip type: Stake Needle LuerLock Other:

Tip cap style:


Graduations: Yes No

Type: Label Screenprint

Safety device: Yes No

Manufacturer:


Primary Packaging (continued)

Seal

Seal: Flip off (west) Other:

Disc color:

Aluminum color:

Article/drawing number:



Plunger Rod

Color:

Catalogue number:

Supplier:


Plunger/Stopper (Syringes)

Cartridge

Size:

Catalogue number:

Supplier:

Glass (USP Type I, II, or III):



Formulation:

Mold number:

Coating:

Type:

Supplier:

Contact:

Silicone treatment may be required for optimal

seating of the plunger. Is silicone treatment of the

plungers permitted?

Yes No


Inserted plunger depth:



Plunger/Stopper (Cartridges)


Combi Seal

Bilayer: Yes No

Disc color:

Aluminum or lacquer color:

Article/drawing number:


Formulation:

Mold number:

Coating:

Type:

Supplier:

Contact:

Silicone treatment may be required for optimal

seating of the plunger. Is silicone treatment of the

plungers permitted?

Yes No


Inserted plunger depth:



Inspection: Manual Semi-automated Automated

Secondary Packaging and Inspection

Inspection

Secondary Packaging

Secondary packaging: Bulk packaging Unit packaging

If unit packaging:

Labeling: Individual unit label Individual graduated unit label No label

Individual unit carton: Yes No

Insert: Yes No

Blister pack: Yes No

Tamper evident seal: Yes No

Inserted into safety device, Yes Noauto injector, or pen:

Units per carton:

Units per case:Distribute to multiple

countries?

Attachment: Please attach artwork and corresponding technical specifications.

Bundle Case Pallet

Yes No

Serialization required? Yes No

If yes, check one: Unit

Additional comments:


Additional Environmental Health and Safety (EHS) Information

This chart represents a classification of active substances for hazard classes based on their pharmacological and toxic effects.

Occupational Exposure Band (OEB)

PropertiesOccupational Exposure Limit (OEL)

G1 Very little pharmacological and toxic effect:• No evidence of reproductive hazards (such as fertility disturbances,

disturbances in embryonic development) -and-• No evidence of disturbing effects on organ functions (e.g., liver,

circulation, CNS, kidney) -and-• No evidence of genetic changes (cell division cycle, DNA adducts).

≥ 1000 μg/m³

G2 Minor pharmacological and toxic effect:• Evidence of minor or reversible fertility impairment at high dosages

(exceeding the therapeutic dose range by far at high dosages in animal tests) -or-

• Evidence of minor and reversible changes in organ function (e.g., liver, circulation, CNS, kidney) and/or changes at high dosages (exceeding the therapeutic dose range by far and/or at high dosages in animal tests) -and-

•No evidence of genetic changes (cell division cycle, DNA adducts)

100 to < 1000 μg/m³

G3a Moderate pharmacological and toxic effect:• Evidence of reversible reproductive disturbances (such as fertility

disturbances, delayed embryonic development) at medium dosages (exceeding the therapeutic dose range by far and/or medium dosage in animal tests) -or-

• Evidence of reversible organ dysfunction (e.g., liver, circulation, CNS, kidney) and/or changes at medium dosages (exceeding the therapeutic dose range by far and/or at medium dosages in animal tests) -and-

•No evidence of genetic changes (cell division cycle, DNA adducts)

10 to 100 μg/m³

G3b Major pharmacological and toxic effect:• Evidence of reproductive disturbances (such as fertility disturbances,

disturbances in embryonic development) at low dosages -or-• Evidence of organ dysfunction (e.g., liver, circulation, CNS, kidney)

and/or changes at low dosages -or-•Evidence of genetic changes for which an effect threshold exists

1 to < 10 μg/m³

G4 Pronounced pharmacological and toxic effect:• Confirmed reproductive disturbances (such as fertility disturbances,

disturbances in embryonic development) at very low dosages -or-• Confirmed organ dysfunction (e.g., liver, circulation, CNS, kidney)

at very low dosages -or-• Confirmed genetic changes for which no effect threshold exists (e.g.,

DNA adducts)

< 1 μg/m³


Thank You

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In order to submit, please save the completed questionnaire and return it via email to your Baxter contact along with any other documents that are required or applicable.

Table of Contents - Baxter, BioPharma Solutions...BioPharma Solutions Product Questionnaire Page 1...

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