The goal of this workshop is to provide detailed information on the implications of Quality by Design (QbD) for the validation and qualification of tablet manufacturing processes and process development. We will also review the principles of PAT for tablets and capsules and their implications for process control, and introduce important new concepts including the use of risk and process matrices for risk management By the end of the course, you will understand the relationship between QbD principles and tablet development and process validation, understand the processes commonly used to manufacture tablets and capsules, and the factors which affect them, recognise how to identify critical processing parameters, and how to incorporate into a process validation program and understand the principles of PAT, how and where it can be most effectively deployed
Who should attend Tablet formulation and process development staff and those involved in managing process development and validation, and commissioning products into production. Regulatory Affairs staff preparing dossiers for tablet products. Quality Assurance personnel responsible for the design or implementation of tablet process validation protocols. Numbers will be limited to give participants the opportunity for thorough discussion of the issues to be covered by the programme and one on one consultation with speakers. | ||||||
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| Organized by: | PharmaTraining Services | |||||
| Invited Speakers: | To be advised | |||||
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| Deadline for Abstracts: | Not applicable | |||||
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| Registration: | http://www.pharmatrainingservices.com/PharmaceuticalPreformulation-makingthemostofyourcompound.htm | |||||
Sunday, May 24, 2009
Tablet Process Development and Validation and the Application of QbD
Batch size increase without perfoming a process validation
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| For your question there is no guidlines , But if your equipment have a capacity to increase the batch size then you can increase up to 150 kg but for regulatory purpose you have to do process validation | |
rambabu
As per u r question with out process validation on temperory basis u can changate the batch size up to 20%. but it is permenent basis u must be conduct the process validation.
| Answered By: Rizwan Kazmi PhD | | |
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| There is a SUPAC guide line for any change which is not similar to the validated batch with regards to material in the formula, equipment and process | |
what is the meanning of master validation plan & how we take stepwise proceding
| Answered By: George micheal | 2 years ago | | |
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| Planning is the most important part of computer validation. Having a good plan in place with owners, deliverables and check points makes validation easy. A master plan increases the efficiency and consistency of validation and answers the inspector's question: what is your approach towards computer system validation. A master plan is also a requirement of European GMPs. A validation project plan guides validation professionals through the entire validation process from writing specifications to system retirement. However, despite of this importance, the regulated industry is unsure on how to develop and document such planning. | |
Regarding Process validation of tablet manufacturing?
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Integrated Tablet Formulation Development
please email if you are interested in this course
Integrated Tablet Formulation Development
and Tablet Process Development and Validation
Course Dates: 28, 29 & 30 April 2009 POSTPONED to October/November
Venue: to be advised
Cost: any 1 day - £600.00, any 2 days £1160.00, 3 days £1584.00
Speaker: Dr Michael Gamlen
This unique 3 day course introduces and integrates the key elements of tablet development based on the principles of Quality by Design (QbD) set out in ICH Q9:
- Preformulation studies
- Formulation development
- Process development and validation
and explains the important links between each of these. Proper integration of these elements is essential to achieve “Quality by Design” because data from each phase of development is used to control the next step in the development process. By achieving proper integration based on sound scientific principles, many development and production problems can be avoided. The course includes case studies of tablet development at the preformulation and formulation development phases as well a detailed, step by step analysis of all elements of the tablet manufacturing process. Key process parameters and their control are identified.
Who will benefit from the course?
The course is designed for people new to tablet and process development, and those requiring a refresher in the area. It will also benefit Process Development experts wishing to extend their understanding of why processes can go wrong, and regulatory and quality personnel who need to understand the development process.
Programme
Registration and coffee are available each day from 8.30am and course proper starts at 9.15am
Day 1: Preformulation
9.00 Welcome and introductions
9.10 Introduction to preformulation for product development
10.00 Coffee
10.30 Preformulation studies in context
* Making use of your data
11.30 Material Characterisation techniques (1)
12.30 Lunch
14.00 Material Characterisation techniques (2)
14.45 Tablet components and their roles
15.30 Tea
16.00 Excipient compatibility testing
16.45 Case study - applying preformulation in tablet formulation
17.50 Close
18.00 Evening reception
Day 2: Tablet formulation - an introduction
9.00 Introduction to tabletting operations
10.30 Coffee
11.00 Tabletting operations (cont'd)
11.30 Tablet formulation development
12.30 Lunch
13.45 Formulation development case study
14.30 Formulation development case study (2)
15.15 Tea
15.30 Compression testing and use of the Precision Compression Tester
16.30 Preparation for formal stability testing
17.00 Q and A
17.30 Close
16.00 Evening reception
Day 3: Process development and validation
9.00 Workshop introduction
9.20 Quality by design - the basis for process development and validation
10.30 Coffee
11.00 Key Manufacturing processes - purpose, equipment and control (1)
* Blending and lubrication
* Dry Granulation - Roller compaction and slugging
* Wet Granulation
* Granulation end-point control
12.15 Discussion, Review and Q & A
12.30 Lunch
13.30 Case study - blending for direct compression, implementation of recent FDA guidance on blend
sampling. We follow the development of a formulation from hand filled capsules to production tablet
manufacture, reviewing blending options and actual results, and examine the effect of FDA guidance
on blend sample
15.00 Key manufacturing processes - purpose, equipment and control (2)
* Drying
* Sieving
* Tablet compression
* Film coating
16.30 Process control case study - granulation end-point control
* Developing a self-controlling process
17.15 Course ends
18.00 Evening reception
Additional Resources:An extremely comprehensive memory stick will be provided containing extensive resources on preformulation and tablet formulation, as well as colour copies of all presentations and case studies