After the entry into force of cross-contamination preventive regulations, and the increasing pressure of the existing regulatory authorities, the pharmaceutical plants are more than ever focused on the development and implementation of a cross-contamination preventive action plan.
On Mars 1st, 2015 entry into force the chapter numbers 3 and 5 of the GMP, establishing its implementation date as follow:
- December 1st, 2015 for medicines intended for human and produced on share facilities.
- June 1st, 2016 for veterinary medicinal products.
Simultaneously, entry into force EMEA (European Medicines Agency) new Guideline and on October, the GMP Annex number 15.
Simultaneously, entry into force EMEA (European Medicines Agency) new Guideline and on October, the GMP Annex number 15. This new regulation implications are extremely important for the laboratory plants, in particular, in terms of work volume and investments required. Some of the new and more important process that need to be implemented as part of it are:
- APIs toxicological evaluation of every medicinal product manufactured in multi-products plants.
- Risk assessment to evaluate the existing technical and organizational measures regarding the type of product manufactured in the multi-product plant.
- Assessment of the suitability of the methodology used for the Cleaning Validation Master Plan Implementation considering the following aspects:
- Design and optimization of cleaning processes
- Cleaning processes Validation
- Environmental verification.
- Assessment of the suitability of the methodology used for the Cross-contamination Preventive Plan Implementation during the manufacturing, filing, labelling and packaging processes of pharmaceutical products.
After the issuance of the final toxicological report, carried out by one of our experts and based on the data provided by the PDE, a risk assessment is made and the risk level of every APIs is determined. The multi-product manufacturing area is classified regarding the technical and organizational point of view, and FMEA is carried out and then the requires periodically measure are implemented in order to demonstrate that the plan to prevent cross-contamination is adequate and sustainable over time. The most important phases to take into consideration in a plan to prevent Cross-contamination are:
- Toxicological evaluation
- Calculation of PDEs for every API
- Classification of molecules
- Risk Assessment
- Products Categorization
- Description of the organizational measures
- Description of the technical measures
- FMEA implementation
- Cleaning Validation
- Calculation of cleaning process limits and scope
- Matrix of cleaning process
- Worst case scenarios definition
- Cleaning analytical methods
- Environmental Verification
- Development and revision of the plan
- Plan implementation
- Conclusions and reports
Qualipharma is a reference company in Spain. Our company not only cooperates with most of the national laboratory stations but also collaborates with the Spanish Drug Agency on the correct application of this regulation Regulations: Revision of chapter number 3 of the GMPs (entry into force Mars 1st, 2015) Check document PDF Revision of the chapter number 5 of the GMPs (entry into force Mars 1st, 2015) Check document PDF EMEA New guideline (entry into force Mars 1st, 2015) Check document PDF Annex number 15 of the GMPs (entry into force October, 2015) Check document PDF
- Practical, accessible and safe way to introduce new APIs in the multi-product plant
- Reputation, manufacturing competitive advantage and differentiation factor for companies
- New product lines
- Objective data that allows company to make important decisions