Course Background
Compared to other dosage forms, Parenteral Products present unique challenges in both their development and manufacture as their method of administration requires sterile and pyrogen free products. During formulation and development studies, products need to be formulated to meet solubility and stability requirements, as well as ensuring compatibility with manufacturing operations and the intended administration route. Biological products present additional formulation and analytical challenges often including the need for freeze drying to facilitate long term storage.
Primary packaging is particularly critical for parenteral products as sterility and efficacy needs to be maintained throughout the product鈥檚 shelf life. In recent years there has been increasing emphasis on devices to facilitate the administration of parenteral products and enable products suitable for self-administration to be developed.
From a manufacturing perspective, the need to achieve sterile, pyrogen free products that also have extremely low particulate levels is paramount. Facilities, equipment and utilities must all be appropriately designed and validated to ensure that microbial, chemical and physical contamination is prevented. Sterile product operations are considered the highest risk category amongst the main pharmaceutical dosage forms by the regulatory authorities and subsequently, are the focus of detailed licence application review and frequent inspections.
Course Objectives
This Course will provide an overview of the design and manufacture of a range of parenteral products, with a mixture of lectures, case studies and workshops. The workshops are designed to encourage interaction between delegates and presenters and to enhance participants understanding of specific key aspects of parenteral products. The course will cover routes of parenteral administration, types of parenteral product, common formulation strategies and relevant regulatory guidelines.
The formulation of biological and freeze dried products will also be discussed as well as primary packaging and delivery devices.
The discussion of parenteral product manufacture will include problems encountered in the production environment, sterilisation, depyrogenation, media simulations and the quality assurance of parenteral products. The Course will also outline the use of isolators and access barriers for aseptic processing and discuss the quality criteria for water for injection GMP requirements and regulatory expectations specific to parenteral products and sterile processing will be discussed throughout the course.
A feature of the Course is the Workshops designed to enhance participant鈥檚 understanding of specific aspects of Parenteral Products
Summary of Key Benefits of Attending
After attending the course participants should be familiar with:
Product Development and Formulation
Who Should Attend
Graduates, Managers, Scientists and Technical staff in industry or hospitals who wish to develop an overall understanding of the formulation and manufacture of parenteral products. This includes scientists in QA/QC and Regulatory Affairs. The course will be particularly useful for staff that are transferring or changing responsibilities to a role involving the development and manufacture of parenteral products.
Compared to other dosage forms, Parenteral Products present unique challenges in both their development and manufacture as their method of administration requires sterile and pyrogen free products. During formulation and development studies, products need to be formulated to meet solubility and stability requirements, as well as ensuring compatibility with manufacturing operations and the intended administration route. Biological products present additional formulation and analytical challenges often including the need for freeze drying to facilitate long term storage.
Primary packaging is particularly critical for parenteral products as sterility and efficacy needs to be maintained throughout the product鈥檚 shelf life. In recent years there has been increasing emphasis on devices to facilitate the administration of parenteral products and enable products suitable for self-administration to be developed.
From a manufacturing perspective, the need to achieve sterile, pyrogen free products that also have extremely low particulate levels is paramount. Facilities, equipment and utilities must all be appropriately designed and validated to ensure that microbial, chemical and physical contamination is prevented. Sterile product operations are considered the highest risk category amongst the main pharmaceutical dosage forms by the regulatory authorities and subsequently, are the focus of detailed licence application review and frequent inspections.
Course Objectives
This Course will provide an overview of the design and manufacture of a range of parenteral products, with a mixture of lectures, case studies and workshops. The workshops are designed to encourage interaction between delegates and presenters and to enhance participants understanding of specific key aspects of parenteral products. The course will cover routes of parenteral administration, types of parenteral product, common formulation strategies and relevant regulatory guidelines.
The formulation of biological and freeze dried products will also be discussed as well as primary packaging and delivery devices.
The discussion of parenteral product manufacture will include problems encountered in the production environment, sterilisation, depyrogenation, media simulations and the quality assurance of parenteral products. The Course will also outline the use of isolators and access barriers for aseptic processing and discuss the quality criteria for water for injection GMP requirements and regulatory expectations specific to parenteral products and sterile processing will be discussed throughout the course.
A feature of the Course is the Workshops designed to enhance participant鈥檚 understanding of specific aspects of Parenteral Products
Summary of Key Benefits of Attending
After attending the course participants should be familiar with:
- Routes of parenteral administration and the different types of parenteral product
- Critical Quality Attributes for parenteral products
- Common formulation strategies for parenteral products, including approaches to overcome solubility and stability challenges and to meet sustained release criteria
- Formulation and analytical approaches in the development of biological products
- Formulation and manufacture of freeze dried products
- Parenteral product primary packaging and administration devices
- Sterilisation and depyrogenation processes
- Cleanroom standards and environmental monitoring
- The control of Water For Injection and clean steam systems
- Principles of quality control, quality assurance and documentation in relation to parenteral products
- Process validation
- GMP and Regulatory requirements for the development and manufacture of parenteral products
Product Development and Formulation
- Routes of Administration
- Types of parenteral product
- Sterility considerations in parenteral product development
- Target product profiles and quality attributes
- Simple solution formulations
- Formulating poorly soluble drugs
- Slow release parenteral products
- Special considerations when formulating and developing macromolecules
- Types of devices for administration
- Compatibility issues
- Theory and practice of freeze drying
- Formulation and development of freeze dried products
- Freeze drying in a production environment
- Moist and dry heat sterilisation processes
- Chemical sterilisation and disinfection
- Irradiation
- Depyrogenation technologies
- Filtration mechanisms and filter types
- Product compatibility and process development
- Integrity testing
- Cleanroom standards and design
- Aseptic processing considerations
- Environmental monitoring and control
- Isolators and Restricted Access Barriers
- Production and control of water for injection
- Clean steam attributes
- Process validation
- Process simulations
- Production and control of water for injection
- Clean steam attributes
- Regulatory expectations
- GMP issues
- Quality Assurance
Who Should Attend
Graduates, Managers, Scientists and Technical staff in industry or hospitals who wish to develop an overall understanding of the formulation and manufacture of parenteral products. This includes scientists in QA/QC and Regulatory Affairs. The course will be particularly useful for staff that are transferring or changing responsibilities to a role involving the development and manufacture of parenteral products.
