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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
Page 2 of 19BioPharma Solutions Product Questionnaire
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:
Page 3 of 19BioPharma Solutions Product Questionnaire
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
Page 4 of 19BioPharma Solutions Product Questionnaire
Forecast (continued)
First year:
Comment:
Second year:
Comment:
Third year:
Comment:
Fourth year:
Comment:
Fifth year:
Comment:
Identification and Description (continued)
Page 5 of 19BioPharma Solutions Product Questionnaire
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
Page 6 of 19BioPharma Solutions Product Questionnaire
Name:
Quality/Grade: EP USP JP Other:
Supplier (if a special one is required):
Name:
Quality/Grade: EP USP JP Other:
Supplier (if a special one is required):
Name:
Quality/Grade: EP USP JP Other:
Supplier (if a special one is required):
Name:
Quality/Grade: EP USP JP Other:
Supplier (if a special one is required):
Name:
Quality/Grade: EP USP JP Other:
Supplier (if a special one is required):
Name:
Quality/Grade: EP USP JP Other:
Supplier (if a special one is required):
Additional Ingredients or Solvents (i.e., Excluding API)
Ingredient/Solvent 1
Ingredient/Solvent 2
Ingredient/Solvent 4
Ingredient/Solvent 3
Ingredient/Solvent 5
Ingredient/Solvent 6
Page 7 of 19BioPharma Solutions Product Questionnaire
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
Page 8 of 19BioPharma Solutions Product Questionnaire
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
Page 9 of 19BioPharma Solutions Product Questionnaire
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):
Page 10 of 19BioPharma Solutions Product Questionnaire
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)
Page 11 of 19BioPharma Solutions Product Questionnaire
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
Only mark the tests that need to be performed by Baxter.
Indicate if the method needs to be validated/transferred:
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
Validation�Transfer
Validation�Transfer
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
Validation�Transfer
Validation�Transfer
Validation�Transfer
Page 12 of 19BioPharma Solutions Product Questionnaire
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.
Only mark the tests that need to be performed by Baxter.
Indicate if the method needs to be validated/transferred:
Other (please specify):
Other (please specify):
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)
Validation�Transfer
Validation�Transfer
Validation�Transfer
�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).
Page 13 of 19BioPharma Solutions Product Questionnaire
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):
Certificate according to: EP USP JP
Silicone treatment may be required for optimal seating of
the stopper. Is silicone treatment of the stoppers permitted?
Yes No
Attachment: Please attach a drawing, specification, or certificate document.
Primary Packaging
Vial
Stopper (Vials)
BioPharma Solutions is prepared to support you with the packaging needs for your specific product:
Page 14 of 19BioPharma Solutions Product Questionnaire
Syringe
Size:
Catalogue number:
Supplier:
Glass/Polymer:
Nest configuration:
Baked silicone: Yes No
Tip type: Stake Needle LuerLock Other:
Tip cap style:
Certificate according to: EP USP JP
Graduations: Yes No
Type: Label Screenprint
Safety device: Yes No
Manufacturer:
Attachment: Please attach a drawing, specification, or certificate document.
Primary Packaging (continued)
Seal
Seal: Flip off (west) Other:
Disc color:
Aluminum color:
Article/drawing number:
Attachment: Please attach a drawing, specification, or certificate document.
Page 15 of 19BioPharma Solutions Product Questionnaire
Plunger Rod
Color:
Catalogue number:
Supplier:
Primary Packaging (continued)
Plunger/Stopper (Syringes)
Cartridge
Size:
Catalogue number:
Supplier:
Glass (USP Type I, II, or III):
Certificate according to: EP USP JP
Attachment: Please attach a drawing, specification, or certificate document.
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
Certificate according to: EP USP JP
Inserted plunger depth:
Attachment: Please attach a drawing, specification, or certificate document.
Page 16 of 19BioPharma Solutions Product Questionnaire
Plunger/Stopper (Cartridges)
Primary Packaging (continued)
Combi Seal
Bilayer: Yes No
Disc color:
Aluminum or lacquer color:
Article/drawing number:
Attachment: Please attach a drawing, specification, or certificate document.
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
Certificate according to: EP USP JP
Inserted plunger depth:
Attachment: Please attach a drawing, specification, or certificate document.
Page 17 of 19BioPharma Solutions Product Questionnaire
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:
Page 18 of 19BioPharma Solutions Product Questionnaire
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
Page 19 of 19BioPharma Solutions Product Questionnaire
Thank You
Congratulations! You have reached the end of the BioPharma Solutions Product Questionnaire.
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.