Dr Ulli Backofen, Boehringer Ingelheim Pharma, Germany
Dr Thomas Fürst, Boehringer Ingelheim Pharma, Germany
Dr Cornelia Nopitsch-Mai, Quality Assessor, Germany
Dr Thomas Uhlich, Bayer, Germany
This Live Online Training covers different aspects of specifications for Active Pharmaceutical Ingredients (APIs = Drug Substances), biological substances and pharmaceutical drug products from an analytical and regulatory perspective. The examples presented will help the participants to define or to evaluate specifications in their daily work.
In the development of new pharmaceutical products it is a great challenge to establish meaningful and reasonable specifications, which are scientifically sound and appropriate for APIs (chemical and biological drug substances), excipients and drug products. According to ICH Guideline Q6A, a specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described.
The analytical result, which will be compared to the specification, is affected by the variability of the measurement itself and depends also on the sampling process and on the variability of the manufacturing process of the tested product itself. This makes statistical considerations essential and consideration of the associated measurement uncertainties vital when setting or complying with specifications.
Analytical methods that were not “stability-indicating” are frequently cited in FDA 483s and Warning Letters. This Live Online Training will thus address how to set impurity limits for related substances and degradation products based on method capability and stability results.
This Live Online Training is of particular interest to specialists from QA, QC and Regulatory Affairs departments of the API and pharmaceutical industry and CROs as well as to members of the EU inspectorates and authorities.
During the Q&A sessions, participants have the opportunity to exchange their experiences they gained with the different aspects of ‘specifications’ with the experts from the API and pharmaceutical industry as well as with members of competent authorities.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
09.00 – 09.15 h
09.15 – 09.45 h
Basic Principles for Setting of Release and Shelf-life Specifications
- Some basic statistics: Distribution and Variation
- Variation and specifications
- Changes over time and shelf life specification
- Process Capability
- Control strategy
- QbD or not to be
09.45 – 10.45 h
Current Regulatory Requirements for Setting Specifications (ICH Q6A)
- Regulatory overview
- Impact of pharmacopoeial provisions
- Setting specifications for active substances and finished products
- Justification of specifications
- Introduction to the requirements of risk assessment with focus on setting specifications for heavy metals
- How authorities will proceed in respect of submitting the required documentation for approved marketed products
10.45 – 11.00 h
11.00 – 11.45 h
Specifications of Biopharmaceuticals
- Overview of regulatory requirements
- Critical Quality attributes and Control Strategy
- Differences between NCEs and NBEs
- Considerations for Drug Substance and Drug Product
- Specifications during early and late stage development
- Acceptance criteria at release and for shelf life
11.45 – 12.30 h and 13.15 – 13.45 h
Rational Development and Justification of API Specifications (Part 1 and Part 2)
- Impurity identification and profiling
- Impurity tracking
- Classification of impurities
- Thresholds for Drug Substance
- Assay, organic impurities and degradation products, water, residual solvents, heavy metals, particle size distribution, polymorphs, genotoxic impurities etc.
12.30 – 13.15 h
Q&A sessions after each presentation ensure interaction and that your questions are answered.
13.45 – 14.45 h
Setting Specifications throughout Drug Development
- Specifications throughout development
- Specifications in Pharmacopoeias
- Stability of the manufacturing process
- Specifications for comparator products
14.45 – 15.00 h
15.00 – 15.45 h and 16.00 – 16.30 h
Rational Development and Justification of Drug Product Specifications (Part 1 and Part 2)
- Specification types
- Regulatory limits and limits based on data
- Typical tests for different types of drug products, e.g.assay, purity, content uniformity, dissolution, fill volume, endotoxines, sterility etc.
15.45 – 16.00 h
16.30 – 17.15 h
Specifications for Specific Drug Products – What is the Difference to Standard Formulations
- Specific aspects required for special drug products, e.g.
- Gastro-intestinal therapeutic systems (GITS) or osmotic-controlled release oral delivery systems (OROS)
- Transdermal patches
- Orally inhaled and nasal drug products (OINDPs)