Scribd Logo
Upload

Welcome to Scribd!

  • List of Documents: 01.manufacturing Site

    Uploaded by

    Shahadat Hossain Tipu
    32 views2 pages
    The document lists various documents required for different departments of a manufacturing site including Production, Quality Assurance, Quality Control, Product Development, Microbiology, Warehouse, Engineering, Sanitation and Hygiene and Product Marketing and Development. Key documents listed include Standard Operating Procedures, Master Files, Manuals, Logs, Specifications, Protocols and Plans.

    Original Description:

    Document

    Original Title

    Documents List

    Copyright

    © © All Rights Reserved

    Available Formats

    DOCX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    The document lists various documents required for different departments of a manufacturing site including Production, Quality Assurance, Quality Control, Product Development, Microbiology, Warehouse, Engineering, Sanitation and Hygiene and Product Marketing and Development. Key documents listed include Standard Operating Procedures, Master Files, Manuals, Logs, Specifications, Protocols and Plans.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    32 views2 pages

    List of Documents: 01.manufacturing Site

    Uploaded by

    Shahadat Hossain Tipu
    The document lists various documents required for different departments of a manufacturing site including Production, Quality Assurance, Quality Control, Product Development, Microbiology, Warehouse, Engineering, Sanitation and Hygiene and Product Marketing and Development. Key documents listed include Standard Operating Procedures, Master Files, Manuals, Logs, Specifications, Protocols and Plans.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 2

    List of Documents

    01.Manufacturing Site 01. Site Master File


    02. Drugs Master File
    03. Training Manual
    04. Health & Safety Manual
    05. Job Description
    06. Factory Organogram
    07. Administrative Structure
    08. Organizational Structure
    09. And Relevant Documents
    02. Production Dept. 01. SOPs ( Operational , Cleaning)
    02. BMR
    03.BPR (Primary & Secondary)
    04. Change Control
    05. Reconciliation & Deviation Form
    06. Production Checklist & Forms
    07. Machines Log Book
    08. And Relevant Documents
    03. Quality Assurance Dept. 01. SOP OF SOP
    02. SOPs
    03. Complaints & Product Recalls
    Procedure/Handling
    04. And Relevant Documents
    04. Quality Control Dept. 01. laboratory Safety Manual
    02. Quality Control Checklists & Forms
    03. Standard Product Specifications
    04. Quality Manual
    05. SOPs (Active & Excipient)
    05. Standard Test Procedure of
    Packaging material
    06. Water Test Specification
    07. Machine Calibration
    08. SOP of Ref. Std. / Working std.
    09. Real Time stability Protocol
    10. Stability Protocol
    11. Validation Master Plan
    12. Validation Protocols
    13. Method Validation & Process
    Validation
    14. And Relevant Documents
    05. Product Development Dept. 01. SOPs for PD Activity
    06. Microbiology Dept. 01. SOPs for Microbiology Activity
    06. Warehouse (RM/PM) 01. SOPs
    07. Engineering Dept. 01. SOPs
    02. Qualification Stage
    i) DQ ii) IQ iii) OQ iv) PQ
    02.Water System
    i) Maintenance of Water System
    ii) System Sanitization
    03. Pest & Dust Control
    04. Preventive Maintenance
    05. And Relevant Documents
    08. Sanitation & Hygiene 01. Procedures For Sanitation and/or
    Cleaning (Premises & Equipment)
    02. Personal Hygiene
    03. And Relevant Documents
    PMD Documents
    01.Marketing Plan
    02. Market Forecasting
    03. Market Analysis
    04. Product Budget
    05.Product Budget
    PMD Activity 06. New Product Launch
    07. Training Manual
    08. SWOT Analysis
    09.Promotional Budget
    10.And Relevant Documents

    You might also like