In the manufacture of medicinal products and APIs, the cleaning of facilities and equipment is an important measure to avoid contamination and cross contamination. In compliance with the GMP regulations, cleaning is performed and documented according to the described procedures. In the past, cleaning effectiveness was often monitored only visually. However, residuals of APIs and excipients as well as of detergents are increasingly an issue in inspections and audits. The success of cleaning procedures has to be validated. In addition to the FDA “Guide to Inspection of Cleaning Validation”, the PIC/S document PI 006 and Annex 15 address cleaning validation in a separate chapter. Moreover, the ICH Guideline Q7 “GMP for APIs” also requires cleaning validation – as well as two guidelines by APIC, the association
of European API manufacturers. A new Guideline from EMA on Dedicated Facilities and Exposure Limits for Cleaning Validation and the revised Annex 15 now deal with a PDE (Permitted Daily Exposure) approach. Background Many questions relative to cleaning validation are still open and have to be answered within the companies:
Hintergrund
Many questions relative to cleaning validation are still open and have to be answered within the companies:
What does the cleaning validation concept have to look like to be GMP-compliant and cost-effective?
Which risk analyses are applicable to cleaning validation?
How helpful can a riboflavin test be?
Which maximum value is scientifically acceptable, especially in the field of APIs?
Which sampling procedure is appropriate for which process and facility?
How can you cut costs by means of bracketing?
How are critical areas defined?
Is cleaning evaluation the solution for seldom manufactured products?
Which microbiological maximum values are valid in the areas of non-sterile dosage forms and APIs?
and
Special aspects of cleaning validation in biotech API plants These questions will also be discussed with the help of practical examples.
Zielgruppe
This course is directed at staff of R&D, production and quality assurance involved in cleaning validation. It also addresses Engineering companies interested in learning more about the pharmaceutical industry‘s viewpoint and in exchanging experiences. Note: The number of participants is limited.
Four parallel Workshops
Four parallel workshops, concentrating on medicinal products, chemical and biological manufactured APIs, and about the organisation of cleaning validation guarantee the practical orientation. Please choose your workshop when registering.
Determination of the critical parameter (SMART objective)
Sampling selection based on a risk-based assessment
Cleaning documentation life cycle
Cleaning Validation Concepts
Introduction of relevant Guidelines
CV Concepts
CV Risk Management
CV Plan
CV Report
CV Revalidation, CV Verification
Typical inspection findings, warning letters
Cleaning Validation in Biotech API Plants
What is different between chemical and biotech APIs?
Acceptance criteria for biotech APIs
What is the adequate analytical method to detect biotech APIs in cleaning validation
Special Aspects of Cleaning Validation
Acceptance criteria
Cleaning methods: CIP, WIP, manual cleaning
Random Controls
Hold time studies: DHT, CHT
Validation of analytical methods used for CV
Cleaning Evaluation and Validation in Chemical API Production
Differences regarding cleaning in API production to the production of medicinal products
The challenges of API production
- Acceptance criteria
- Adequate sampling
Is cleaning evaluation accepted by GMP?
Technical and Organisational Aspects on Equipment Regarding Cleaning Procedures
Design and material aspects
Requalification
CIP aspects
Riboflavin test
Maintenance
How to write a Cleaning Validation Protocol
Team and project validation creation (benchmarking best practice)
GMP requirements and best practice for a protocol redaction and content
Quality attribute to be tested for non- and sterile manufacturing
Sampling and analysis methods overview
Examples through a case study – validation and implementation in routine
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Teilnehmerstimmen - das sagen andere über unsere Seminare:
„Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis, welche die Theorie super veranschaulicht.” Marina Kicoranovic, Labor Hartmann GmbH GMP/Basis-Einstiegsschulung (B 14), September 2023
„Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe verwendet (super) und waren sehr praxisbezogen.” Astrid Gießler, Regierungspräsidium Karlsruhe Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023
„Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.” Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG GMP-Basisschulung (B 1), Juni 2023