Welcoem to posts!!
in the future - u will be able to do some more stuff here,,,!! like pat catgirl- i mean um yeah... for now u can only see others's posts :c
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41 pages SOP for Analytical Method Validation to Share the link, Simply write LINK in Comments
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Quality Assurance vs Quality Control
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5 Essential Components of GMP for Every Pharma Professional
Read Full Article HERE
pharmuni.com/2024/09/23/5-essential-components-of-โฆ
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Sterile Manufacturing Based on EU GMP Annex 1
If you want to have link of FREE EU GMP course with EU Aproved Certification simply Write LINK in Comments
A Sterile Manufacturing Factory, particularly in the pharmaceutical or biotechnology industries, has several critical components to ensure a sterile environment and compliant production process. Here's a list of the main areas and systems typically found in such a facility:
1. Cleanrooms
- ISO Classifications: ISO 5, ISO 7, ISO 8 for different levels of air cleanliness.
- HVAC Systems: Designed for maintaining temperature, humidity, and pressure differentials.
- HEPA Filters: To ensure removal of airborne particles and microorganisms.
2. Sterilization Equipment
- Autoclaves: For steam sterilization of equipment, materials, and sometimes the final product.
- Sterile Filtration Systems: For sterile filtration of liquids.
- Depyrogenation Ovens: For removing endotoxins from equipment and containers.
3. Aseptic Processing Areas
- Isolators or Restricted Access Barrier Systems (RABS): Used for maintaining a sterile environment during the manufacturing process.
- Laminar Flow Hoods: To provide a sterile airflow over the working surface.
4. Manufacturing and Filling Equipment
- Sterile Filling Lines: For filling sterile products into containers such as vials, syringes, ampoules.
- Blow-Fill-Seal (BFS) Technology: For aseptic production of containers.
- Lyophilizers (Freeze Dryers): For lyophilization (freeze-drying) of products.
5. Quality Control and Microbiology Labs
- Environmental Monitoring Systems: For regular monitoring of air, surfaces, and personnel for microbial contamination.
- Sterility Testing Labs: For testing finished products to ensure sterility.
- Particle Counting and Microbial Sampling Devices.
6. Material and Personnel Airlocks
- Pass-through Boxes: For transferring materials without breaching sterility.
- Gowning Areas: For personnel to don sterile clothing before entering clean areas.
7. Water Systems
- WFI (Water for Injection) Systems: For providing sterile water used in production.
- Clean Steam Generators: Used for sterilizing equipment and in the production process.
8. Warehousing and Material Storage
- Controlled Storage Areas: For storing raw materials and finished products in controlled environmental conditions.
- Cold Storage: For temperature-sensitive products.
9. Automation and Control Systems
- Building Management Systems (BMS): For controlling and monitoring the environment in critical areas.
- Supervisory Control and Data Acquisition (SCADA): For automating and controlling production processes.
10. Personnel and Training Facilities
- Training Rooms: To ensure all staff follow strict aseptic techniques.
- Personnel Monitoring: Regular checks to ensure compliance with gowning and hygiene procedures.
11. Waste Management
- Decontamination Systems: For proper disposal of biological or chemical waste.
- Effluent Treatment Systems: To safely manage liquid waste.
Each of these systems plays a vital role in maintaining the sterile integrity and ensuring the quality of the products manufactured in the sterile environment.
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GMP VS cGMP
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5 Zones of ICH Stability
Zone I: This zone represents the most stable conditions, with low temperature and low humidity levels. Products stored in this zone typically have a longer shelf life.
Zone II: This zone has slightly higher temperature and humidity levels compared to Zone I. Products stored in this zone may have a shorter shelf life compared to those stored in Zone I.
Zone III: This zone has higher temperature and humidity levels compared to Zone II. Products stored in this zone may have a limited shelf life and may require additional packaging or storage conditions to maintain stability.
Zone IV: This zone represents the least stable conditions, with high temperature and humidity levels. Products stored in this zone are at risk of degradation and may have a very limited shelf life.
Zone IVb: This is an additional zone that is sometimes used to represent extreme conditions, such as high temperature and high humidity levels. Products stored in this zone are at high risk of degradation and may require specialized storage conditions to maintain stability.
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GMP Free Course With EU Approved Certification
LINK IN COMMENTS
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Welcome to Pharmatalks!
In the pharmaceutical industry, compliance with Good Manufacturing Practices (GMP), regulatory requirements, and quality control standards is crucial for ensuring the safety and efficacy of medications. At Pharmatalks, our mission is to provide you with comprehensive guidance on the latest developments, best practices, and regulations in the pharmaceutical industry.
Our channel covers a wide range of topics, including:
GMP : From facility design to equipment validation, we'll guide you through the essential elements of good manufacturing practices.
Pharmaceutical industry : Learn about the importance of quality control and assurance in ensuring the safety and efficacy of pharmaceutical products.
Subscribe to Pharmatalks today and stay ahead of the curve in the pharmaceutical industry!