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    Preformulation/Formulation Project Initiation Form: Client Information

    Uploaded by

    monika19777
    This document is a project initiation form for a pharmaceutical development company. It provides information about the client, nature of the work to be performed, product details, technical background, analytical development details, safety information, standards, columns, data, quality assurance procedures, reporting format, technology transfer plans, and sample disposal procedures. The form is intended to capture all relevant details needed to initiate a preformulation/formulation project for a client.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd

    Preformulation/Formulation Project Initiation Form: Client Information

    Uploaded by

    monika19777
    41 views2 pages
    This document is a project initiation form for a pharmaceutical development company. It provides information about the client, nature of the work to be performed, product details, technical background, analytical development details, safety information, standards, columns, data, quality assurance procedures, reporting format, technology transfer plans, and sample disposal procedures. The form is intended to capture all relevant details needed to initiate a preformulation/formulation project for a client.

    Original Title

    Formulation

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    This document is a project initiation form for a pharmaceutical development company. It provides information about the client, nature of the work to be performed, product details, technical background, analytical development details, safety information, standards, columns, data, quality assurance procedures, reporting format, technology transfer plans, and sample disposal procedures. The form is intended to capture all relevant details needed to initiate a preformulation/formulation project for a client.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    41 views2 pages

    Preformulation/Formulation Project Initiation Form: Client Information

    Uploaded by

    monika19777
    This document is a project initiation form for a pharmaceutical development company. It provides information about the client, nature of the work to be performed, product details, technical background, analytical development details, safety information, standards, columns, data, quality assurance procedures, reporting format, technology transfer plans, and sample disposal procedures. The form is intended to capture all relevant details needed to initiate a preformulation/formulation project for a client.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    A Pharmaceutical Development Company.

    PREFORMULATION/FORMULATION PROJECT INITIATION FORM


    CLIENT INFORMATION:
    Contact Name: Title: Mailing Address: Phone #: Email address: Salutation (Mr., Ms., Dr.,): Company Name: City, State, Zip Code: Fax #: Company website:

    IRVINE AREA MANAGER:


    Contact Name: Title: Mailing Address: Phone #: Email address: Charles Petersen Dir., Formulation Development 10 Vanderbilt 949-951-4425 charles.petersen@irvinepharma.com Salutation (Mr., Ms., Dr., ): Company Name: City, State, Zip Code: Fax #: Company website: Dr. Irvine Pharmaceutical Services Irvine, CA 92618 949-951-9224 http://www.irvinepharma.com

    NATURE OF WORK:
    cGMP Method Development GC/MS LC/MS ELISA CE Gel Electrophoresis non cGMP AAA Extractables/Leachables Method Validation Cleaning Validation Method Optimization Method Feasibility Extend to Stability Preformulation Formulation API Characterization Other (please describe)

    PRODUCT INFORMATION:
    Name of Product: Product Description: (# of strengths / # of lots) Product Matrix DPI Nebulized MDI Nasal Lyophile Solution Suspension Capsule/ Tablet Other (please describe) Finished Dosage Form: Packaging Configuration: Dosage Form Strength: N Excipients: Development Phase Pre-IND I II III FDA Approved Other (please describe)

    Placebo included? Y N API: Crystaline: Y N Aqueous Solubility: Y Hydroscopic: Y N Y N Stable: Sensitive to Light: Y PKa Value: Salt Form: Finished Dosage Form:

    N Value:

    TECHNICAL BACKGROUND:
    Physical and Chemical Properties Previous Work at Irvine Special Equipment Needs? Identify ___________________________________________________________________________

    1 of 2

    A Pharmaceutical Development Company.

    ANALYTICAL DEVELOPMENT DETAILS:


    Method Development Characteristics: Method will be provided by client Type of Method: Assay Related Substances Stability-Indicating Preservative CE Method Validation Characteristics: Linearity Accuracy Precision Range Specificity Robustness System Suitability Intermediate Precision Limit of Detection Limit of Quantification Standard (Sample) solution stability Other (please describe):

    Gel Identification SEC Inorganic Residues Other:

    SAFETY INFORMATION:
    Hazardous Yes No If yes, list type(s): Mass/volume to be sent: Special Handling Requirements: Unknown DEA Controlled No X I II III IV V

    Please attach MSDS (required).

    STANDARDS, COLUMNS, AND RAW DATA:


    Reference Standards provided by: Client Irvine* Notes: ___________________________ Reference Standards characterized by: Client Irvine * ___________________________ Columns provided by: Client Irvine * ___________________________ * Project specific materials, purchased through Irvine Pharmaceutical Services, will be charged to Client at Irvine invoiced price

    QUALITY ASSURANCE:
    Full QA Review Peer Review Other: ____________________________________________________________

    FINAL REPORT:
    Irvine Template Client Template Other: ____________________________________________________________

    TECH TRANSFER:
    Back to client To Irvine AC Other: ____________________________________________________________

    DISPOSAL OF SAMPLES:
    Standard (30 days post report): Special Handling (return to client): Attention: _________________________________ Address: _________________________________ _________________________________ Client Shipping Account Number: _____________________

    ADDITIONAL NOTES (attach other pages as needed):

    2 of 2

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