the greneric manufacturing
Page 1: Introduction to Pharmaceutical Manufacturing
Title: PHARMA 3 Pharmaceutical Manufacturing: MNUF S7001 - Topic 2: The Generic Manufacturing Process (Kerry Devlin)
Page 2: Learning Outcomes
Objective: Successful completion will enable learners to:
Categorize manufacturing activities, inputs, outputs using a Generic Process Approach model.
Page 3: Key Topics in Generic Manufacturing Process
Life History of a Drug
Generic Manufacturing Process:
Process Definition
Manufacturing Process Diagram
Documenting the Process
Flowcharts:
Types (macro, intermediate, micro level)
Benefits of Flowcharting
Construction of Flowcharts
Flowchart Symbols
Manufacturing Layout:
Typical Layout
Considerations in Layout Design
Tutorial Completion: Emphasis on Topic 2.
Page 4: Regulatory Environment in Pharmaceutical Manufacturing
Regulation: Highly regulated industry by governmental authorities globally.
Purpose of Regulations: Ensure control and regulation of all industry aspects.
Enforcement: Done by government-established regulatory bodies.
Page 5: Life History of a Drug
Phases:
Drug Discovery
Initial Characterization
Pre-clinical Trials
Regulatory Approval for Human Trials
Marketing/Manufacturing Applications submission
Regulatory review for licenses
Manufacture Product
Regulatory Audits
Post-Market Surveillance: Ongoing reviews by regulatory authorities post-launch.
Patent Consideration: Often sought during early clinical trials.
Page 6: Business Process in Manufacturing
Key Components:
Manufacturing Processes
Stakeholder Requirements (Goals & Targets)
Inputs: Specifications, SOPs
Outputs: Results & Records
Page 7: Process Definition
Definition: Any activity using resources to transform inputs into outputs.
Page 8: Breakdown of Processes
Types of Activities: Milling, Sieving, Coating, Drying, Mixing.
Resources Used:
Man-hours
Equipment
Materials
Methods
Facilities
Data
Transformation: Process creates a state change in inputs to produce outputs.
Page 9: Information Processing Example
Data Transformation: Raw data processed into interpretable forms (e.g., Trend Charts).
Resource Consumption: All processes utilize resources including people and materials.
Page 10: The Generic Manufacturing Process Overview
Page 11: Manufacturing Process Diagram
Components of Generic Model:
Inputs: Resources (Man-hours, Machines, Materials)
Outputs: Deliverables (Products, Information, Services)
Goal: Achieve specified results/records.
Page 12: Example of Generic Process for a Painkiller Tablet
Outputs:
Product type (Generic Tablet)
Batch No., Quantity, Expiry dates.
Inputs:
Man-hours, Machines, Raw Materials, Processes, Utilities, Data Registration.
Goals and targets aligned for monitoring and analysis.
Page 13: Manufacturing Process Questions
List of Critical Questions to guide process understanding:
What are the inputs & outputs?
Are process steps documented?
How is process measured and qualified?
Are relationships to other processes identified?
Page 14: Examples of Flow Diagrams
Page 15-32: Process Flow Diagrams and Demonstrations (Examples not examinable)
Block Flow Diagrams: Providing illustrative overviews of complex processes, including chemical reactions and separations.
Page 33-35: Standard Operating Procedure (SOP)
Definition: Key document setting the standards for operational processes in manufacturing.
Function: Prescribes procedures that cover various aspects of operations, ensuring consistency and quality in results.
Page 36-39: The Need for Standardization
Importance: Ensures processes are performed consistently, reducing errors and enhancing quality.
Training Document: SOPs serve as a training tool for new employees.
Page 40-44: Process Flow Diagrams
Use Cases: Visual representation of processes to facilitate understanding and identify critical steps.
Page 45-52: Flowcharting
Benefits: Visual aids for process reliability, communication, and critical step identification.
Construction Techniques: Steps required for effective flowchart design, including use of standard symbols.
Page 53-54: Flowcharting Symbols
Overview of symbols used in flowcharting for documenting and analyzing processes.
Page 55-57: Formal Construction of Flowcharts
Construction Steps: Guidelines for developing comprehensive flowcharts, including scoping and sequencing.
Page 58-60: Levels of Flowcharting
Macro, Intermediate, Micro Level: Distinct levels for complexity in flowchart details.
Page 61-63: Further Examples of Manufacturing Process Diagrams
Page 72-83: Manufacturing Layout Considerations
Design Issues: Cross-contamination prevention, cGMP adherence, hygiene, health & safety, space for Segregation, Quarantine areas, and Productivity.
Tutorial: Exercises to apply layout principles in manufacturing environments.