Skip to content
  • Clinical Studies
  • Pharma GMP
  • Pharma Tips
  • Stability Studies
  • Pharma Books
  • Schedule M

SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

  • Home
  • Job Safety Analysis (JSA)
    • Oral Dosage Forms (Tablets & Capsules)
    • Oral Liquid Dosage Forms (Syrups, Elixirs, Suspensions, Emulsions)
    • Powder and Granule Dosage Forms
    • Topical Dosage Forms (Creams, Ointments, Gels, Lotions, Pastes)
    • Transdermal Dosage Forms (Patches)
  • Standard Test Procedures (STP)
  • SOP – Blog Post
  • Toggle search form

SOP for Formulation Development Project Closure

Posted on By

SOP for Formulation Development Project Closure

Project Closure in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for the systematic and efficient closure of formulation development projects, ensuring that all activities are completed, outcomes are evaluated, and documentation is finalized in accordance with organizational standards.

2) Scope

This SOP applies to all formulation development projects within the organization, covering the process from project completion to final documentation and archiving.

3) Responsibilities

The responsibilities for this SOP include:
Formulation Development Team: Completing project activities, conducting final evaluations, and preparing closure reports.
Project Manager: Overseeing project closure activities, ensuring compliance with timelines and deliverables.
Quality Assurance: Reviewing project closure documentation to verify completeness and compliance with SOP requirements.
Regulatory Affairs: Ensuring that project closure activities comply with regulatory guidelines and requirements.

See also  SOP for Formulation Development Documentation Management

4) Procedure

4.1 Project Evaluation and Finalization

  1. Conduct a comprehensive review and evaluation of project deliverables, including formulation development outcomes, technical reports, and regulatory submissions.
  2. Verify that all project activities, milestones, and objectives have been achieved as per the project plan and stakeholder expectations.
  3. Document final project evaluations, including lessons learned, successes, challenges, and recommendations for future projects.

4.2 Documentation Completion

  1. Compile and finalize all project-related documentation, including formulation development reports, experimental data, protocols, and SOP updates.
  2. Ensure
that all documentation is accurate, complete, and compliant with regulatory requirements and organizational standards.
  • Review and approve final project documentation with cross-functional input to verify accuracy and completeness.
  • 4.3 Stakeholder Communication

    1. Communicate project closure and outcomes to stakeholders, including formulation development team members, management, regulatory bodies, and other relevant parties.
    2. Address any outstanding issues, questions, or follow-up actions identified during project closure activities.
    3. Obtain feedback from stakeholders regarding project outcomes, process improvements, and lessons learned.

    4.4 Archiving and Retention

    1. Archive all project-related documentation and records in accordance with organizational policies and regulatory requirements.
    2. Maintain a controlled document system for easy retrieval and access to archived project information.
    3. Establish retention periods for project documentation based on regulatory, legal, and business requirements.

    4.5 Project Closure Report

    1. Prepare a comprehensive project closure report summarizing project activities, achievements, challenges, and recommendations.
    2. Include an overview of project outcomes, impact on business objectives, and future implications for formulation development activities.
    3. Review and approve the project closure report for distribution to stakeholders and for archival purposes.

    5) Abbreviations, if any

    SOP: Standard Operating Procedure

    6) Documents, if any

    Project Closure Report
    Final Project Documentation
    Archived Project Records

    7) Reference, if any

    – ICH Q10: Pharmaceutical Quality System
    – ISO 9001: Quality management systems – Requirements

    8) SOP Version

    Version 1.0

    See also  SOP for Formulation Development Stability Study Monitoring
    Formulation Development Tags:API selection SOP, Batch record SOP, Change control SOP, Cleaning Validation SOP, Clinical trial material SOP, Deviation handling SOP, Drug formulation procedure, Equipment Qualification SOP, Excipient selection SOP, Formulation development SOP, Formulation process SOP, GMP SOP, Pharmaceutical SOP, Process Validation SOP, Quality by design SOP, Regulatory submission SOP, Risk assessment SOP, SOP for drug development, SOP for stability testing, SOP guidelines pharmaceutical, SOP pharmaceutical industry, SOP template for formulation, Standard operating procedure formulation, Technology transfer SOP, Validation SOP

    Post navigation

    Previous Post: SOP for Pharmacovigilance Case Narrative Writing
    Next Post: SOP for Cleaning Validation in Aerosol Production

    Standard Operating Procedures V 1.0

    • Aerosols
    • Analytical Method Development
    • Bioequivalence Bioavailability Study
    • Capsule Formulation
    • Clinical Studies
    • Creams
    • Data Integrity
    • Dental Dosage Forms
    • Drug Discovery
    • Environment, Health and Safety
    • Formulation Development
    • Gels
    • Good Distribution Practice
    • Good Warehousing Practices
    • In-Process Control
    • Injectables
    • Liquid Orals
    • Liposome and Emulsion Formulations
    • Lotions
    • Lyophilized Products
    • Maintenance Dept.
    • Medical Devices
    • Metered-Dose Inhaler
    • Microbiology Testing
    • Nanoparticle Formulation
    • Nasal Spray Formulations
    • Nebulizers
    • Ocular (Eye) Dosage Forms
    • Ointments
    • Otic (Ear) Dosage Forms
    • Pharmacovigilance
    • Powder & Granules
    • Purchase Departments
    • Quality Assurance
    • Quality Control
    • Raw Material Stores
    • Regulatory Affairs
    • Tablet Manufacturing
    • Rectal Dosage Forms
    • Transdermal Patches
    • Vaginal Dosage Forms
    • Validations and Qualifications

    Read SOPs in your Language:

     - 
    Bengali
     - 
    bn
    English
     - 
    en
    Gujarati
     - 
    gu
    Hindi
     - 
    hi
    Malayalam
     - 
    ml
    Marathi
     - 
    mr
    Punjabi
     - 
    pa
    Tamil
     - 
    ta
    Telugu
     - 
    te

    NEW! Revised SOPs – V 2.0

    • Aerosols V 2.0
    • Analytical Method Development V 2.0
    • API Manufacturing V 2.0
    • BA-BE Studies V 2.0
    • Biosimilars V 2.0
    • Capsules V 2.0
    • Creams V 2.0
    • Elixers V 2.0
    • Ointments V 2.0
    • Raw Material Warehouse V 2.0
    • Tablet Manufacturing V2.0

    New Publication: A must for All.

    Copyright © 2025 SOP Guide for Pharma.

    Powered by PressBook WordPress theme

    Go to mobile version