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List of Documents: 01.manufacturing Site

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.

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Shahadat Hossain Tipu
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523 views2 pages

List of Documents: 01.manufacturing Site

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.

Uploaded by

Shahadat Hossain Tipu
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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

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