Product Questionnaire

Transcription

1 Product Questionnaire Let 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...2 Product Information...3 Identification and Description...3 Active Pharmaceutical Ingredient (API)...5 Additional Ingredients or Solvents (i.e., Excluding API)...6 Process...7 Compounding...7 Bulk Material and Final Product Compatibility...7 Sterile Filtration...8 Formulated Product...8 Filling...9 Lyophilization...9 Final Sterilization...9 Cleaning Validation...10 Storage, Handling, and Shipping Conditions...10 Additional Process Information...10 Analytical Testing...11 Incoming Active Pharmaceutical Ingredient (API)...11 Drug Product in Process Control...11 Drug Product Release...11 Method(s)...12 Stability...12 Primary Packaging...13 Vial...13 Stopper (Vials)...13 Seal...14 Syringe...14 Plunger/Stopper (Syringes)...15 Plunger Rod...15 Cartridge...15 Plunger/Stopper (Cartridges)...16 Combi Seal...16 Secondary Packaging and Inspection...17 Additional Environmental Health and Safety (EHS) Information...18 Page 1 of 19

2 Contact Information Date: Company Name and Address Company name: Address: City: State: Zip: Country: Web site: Primary Contact Last name: First name: Department/title: Phone: Fax: Secondary Contact Last name: First name: Department/title: Phone: Fax: Page 2 of 19

3 Product Information Identification and Description Identification Product name: Generic name: Formulation strength(s): Please attach Material Safety Data Sheet (MSDS) and/or Toxicology Studies, Investigational Brochure, Safebridge Assessment. Description Product type: Liquid Lyophilizate Powder Sterile crystallizate Suspension/Emulsion Product indication: Application/Use: Regulatory Requirements 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: Timeline Project start date: When are the first batches required? Forecast Estimated market launch date: Annual units: Proposed batch size: Page 3 of 19

4 Identification and Description (continued) Forecast (continued) First year: Comment: Second year: Comment: Third year: Comment: Fourth year: Comment: Fifth year: Comment: Page 4 of 19

5 Active Pharmaceutical Ingredient (API) Identification API name: Chemical name: Chemical abstract number: Exposure limit/band: OEL: /m 3 or OEB (Occupational Exposure Band): class /4 General 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 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: Page 5 of 19

6 Additional Ingredients or Solvents (i.e., Excluding API) Ingredient/Solvent 1 Name: Quality/Grade: EP USP JP Other: Supplier (if a special one is required): Ingredient/Solvent 2 Name: Quality/Grade: EP USP JP Other: Supplier (if a special one is required): Ingredient/Solvent 3 Name: Quality/Grade: EP USP JP Other: Supplier (if a special one is required): Ingredient/Solvent 4 Name: Quality/Grade: EP USP JP Other: Supplier (if a special one is required): Ingredient/Solvent 5 Name: Quality/Grade: EP USP JP Other: Supplier (if a special one is required): Ingredient/Solvent 6 Name: Quality/Grade: EP USP JP Other: Supplier (if a special one is required): Page 6 of 19

7 Process 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 All excipients are USP grade? Bulk Material and Final Product Compatibility 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: Yes No Please attach a compounding process description document. Page 7 of 19

8 Process (continued) 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 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): Page 8 of 19

9 Process (continued) 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): 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: Please attach a lyophilization cycle document. 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): Page 9 of 19

10 Process (continued) Cleaning Validation List the LD 50 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: Storage, Handling, and Shipping Conditions Labeling and packaging ( C): Drug product storage ( C): Shipping ( C): Additional Process Information Please provide us with the specific process needs for your product. Please attach executed batch record or process flow diagram. Page 10 of 19

11 Analytical Testing Incoming Active Pharmaceutical Ingredient (API) Only mark the tests that need to be performed by Baxter. 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: of analytical method of analytical method Satellite sample included: Yes No Additional information: Drug Product in Process Control Only mark the tests that need to be performed by Baxter. Indicate if the method needs to be validated/transferred: Appearance ph bulk solution (pre-filtration) ph bulk solution (post-filtration) Endotoxins of compounding solution Concentration/Assay pre-filtration by: Concentration/Assay post-filtration by: Microbial purity of compounding solution Endotoxins of bulk solution to sterile filtration Other (please specify): Bioburden of bulk solution prior to sterile filtration Other (please specify): Comments: Drug Product Release Only mark the tests that need to be performed by Baxter. Indicate if the method needs to be validated/transferred: Specification attached Specification TBD Appearance ph Identity by: Purity by: Color Clarity of solution Assay by: Page 11 of 19

12 Analytical Testing (continued) Drug Product Release (continued) Only mark the tests that need to be performed by Baxter. Indicate if the method needs to be validated/transferred: Water content (Karl Fischer) Particulate matter Visual particles Sub-visual particles Other (please specify): Other (please specify): Residual solvents Other (please specify): Bacterial Endotoxin Test (Must be validated by Baxter on 3 product batches) Test for Sterility (Must be validated by Baxter on 3 product batches) Comments: Method(s) Please describe or attach a copy of analytical method(s): Please attach a copy of analytical method(s). Stability Does Baxter need to perform stability studies? Yes No Standard testing duration (months): Other: Which climatic zones should be covered? I II III IV Other: Accelerated testing duration (months): Other: Under which conditions? Has an expiration date been established for this product? Yes No If yes, please describe: Additional comments: Please attach a stability program document. Page 12 of 19

13 Primary Packaging BioPharma Solutions is prepared to support you with the packaging needs for your specific product: Vial 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 Please attach a drawing, specification, or certificate document. Stopper (Vials) 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 Please attach a drawing, specification, or certificate document. Page 13 of 19

14 Primary Packaging (continued) Seal Seal: Flip off (west) Other: Disc color: Aluminum color: Article/drawing number: Please attach a drawing, specification, or certificate document. 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: Please attach a drawing, specification, or certificate document. Page 14 of 19

15 Primary Packaging (continued) Plunger/Stopper (Syringes) 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: Please attach a drawing, specification, or certificate document. Plunger Rod Color: Catalogue number: Supplier: Cartridge Size: Catalogue number: Supplier: Glass (USP Type I, II, or III): Certificate according to: EP USP JP Please attach a drawing, specification, or certificate document. Page 15 of 19

16 Primary Packaging (continued) Plunger/Stopper (Cartridges) 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: Please attach a drawing, specification, or certificate document. Combi Seal Bilayer: Yes No Disc color: Aluminum or lacquer color: Article/drawing number: Please attach a drawing, specification, or certificate document. Page 16 of 19

17 Secondary Packaging and Inspection Inspection Inspection: Manual Semi-automated Automated 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, auto injector, or pen: Units per carton: Units per case: Distribute to multiple countries? Yes Yes No No Serialization required? Yes No If yes, check one: Unit Bundle Case Pallet Additional comments: Please attach artwork and corresponding technical specifications. Page 17 of 19

18 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) Properties Occupational Exposure Limit (OEL) G1 G2 G3a G3b G4 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). 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) 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) 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 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) 1000 μg/m³ 100 to < 1000 μg/m³ 10 to 100 μg/m³ 1 to < 10 μg/m³ < 1 μg/m³ Page 18 of 19

19 Thank You Congratulations! You have reached the end of the. In order to submit, please save the completed questionnaire and return it via to your Baxter contact along with any other documents that are required or applicable. Page 19 of 19