The EMA has published the “Guideline on process validation for finished products – information and data to be provided in regulatory submissions”. This Guideline will come into effect on 15. July 2014.
This guideline replaces the previous note for guidance on process validation (CPMP/QWP/848/96, EMEA/CVMP/598/99). The guideline is brought into line with ICH Q8, Q9 and Q10 documents and the possibility to use continuous process verification in addition to, or instead of, traditional process validation described in the previous guideline has been added and is encouraged.
Ermatingen, Switzerland / Ravensburg, Germany, March 17th, 2014
Mediantis Consult GmbH and CCS are delighted to announce the strategic alliance between both consultancy service providers to the regulated industries.
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The core capabilities of both companies complement perfectly one another, focusing on GCP & Medical Device quality concepts and GMP and application service platforms.
Mediantis Consult GmbH, managed by Dr. Sabine Schäfer-Preuss and Dr. Iris Teutsch and the CCS network resources, managed by Mr. Markus Roemer, are thereby enabled by a comprehensive skills and expertise set to provide excellent services to their clients.
This extraordinary partnership will allow both providers to continue to expand their excellent services ranges and areas by utilizing each other as partner to provide compliance services throughout Europe.
The two firms complement one another’s service offerings and will work together to provide clients with excellent services in GMP & GCP compliance, Quality Management Systems, Inspection Readiness Programs, Audit Management, Training, and Validation.
About Mediantis Consult GmbH
Mediantis Consult GmbH provides high value professional consulting services for Pharma, Biotech and Medical Device Industries:
Comprehensive CONSULTING in Quality Management Systems tailored to client’s individual needs
Detailed ASSESSMENT of existing Processes with a strong focus on regulatory compliance
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Development and delivery of innovative EDUCATION programs
Support in CLINICAL DEVELOPMENT with study management, study specific training and medical writing activities
comes compliance services is a premier consulting company specializing in simplifying and streamlining quality systems, and fulfilling validation and regulatory compliance requirements. The services and products are available to GMP, GDP, GLP, GCP and medical device regulated companies and suppliers. CCS is based on a global and comprehensive network setup and can deliver dedicated subject matter experts to different fields and subjects:
Quality Management Services / Pharmaceutical Quality Systems
Comprehensive and risk-based compliance concepts and services
Informationen zu IT-Infrastrukturen und zum Schutz Ihrer Daten erhalten Sie auf dem „Cross-Cluster-Treff“ mit dem Themenschwerpunkt „IT-Sicherheit“, zu dem das IT-Netzwerk cyberLAGO e.V. und das Life Science Netzwerk BioLAGO e.V. gemeinsam einladen.
Das Forum richtet sich an Vertreter aus Wirtschaft sowie Wissenschaft und lädt Sie ein zum Austausch an der Schnittstelle von Informationstechnik und Life Sciences. Nutzen Sie die Gelegenheit IT-Experten zu Ihrer Datensicherheit zu befragen.
The classical V-model is very often used as the a conceptual model for validation. Most of the V-models are purely designed on a system-based approach, showing in the left wing all sorts of specifications, from URS to design specifications and the right wing all related test phases. Moving away from such a system-based approach in order to follow a risk based approach towards the quality decision making process might impact the existing V-model and a new approach should be used (click picture to enlarge).
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As EU GMP Annex 11 states that applications, and not computerized systems, should be validated, and in real terms we do not validate a computer or system itself, the objective of validation is focused to the quality decision, which is based on the information (recorded in reports and records) derived or given by the entire process, whereas several systems or equipment might be relevant process elements.
EU GMP Chapter 4 – documentation – defines the so called instructions and records/report type. Also the term raw data is used. A GMP record contains such raw data, meta data, master data, on which a decision maker (e.g. Qualified Person, Quality Assurance) is making a quality decision (e.g. Batch Release).
Based on the IT basis such records might support electronic records or is still based on paper records. Ideally all steps (from 10 to 100) are interconnected by the qualified IT architecture.
The fundamental risk is that a wrong quality decision would be made on the basis of insufficient, faulty, tampered or missing data, directly impacting product quality, data integrity, and patient safety. So each system providing data to a GMP relevant record (e.g. Certificate of Analysis, Batch Records, etc.) should be seen as a data sources, forcing, collecting, monitoring, analyzing or calculating data along the entire data flow.
Potentially the highest risk is in each manual step, where data is entered by an operator – whereas a qualified interface of e.g. scanners are reducing the risk of faulty data entries (steps 20, 40, 60, 80).
Step 10 defines critical process parameters, which are derived from product critical attributes, linking product (license) to the process. If a Quality by Design approach is followed, the Design Space will be the basis for the Control Strategy.
A modern approach to computer system validation requires the mapping of the data objects and flows to the final documentation in GMP records. This approach should include the verification of data integrity, as required by EU GMP Annex 11 and US-FDA 21 CFR Part 11.
On the other hand there must be a comprehensive IT strategy including systems, platforms, and interface technology in order to reach the goal of a full electronic recording of all relevant processes. By the way, companies implementing such a holistic data management approach increase efficiency and productivity extensively: Implementing GMP datability & compliance as guarantor of success.
For more information contact us at: talk@comes-services.com or use our online contact form.
Aus unserer Sicht ist die aktuelle Draft Version, die zur Kommentierung veröffentlich wurde, sehr undurchsichtig und unzureichend formuliert. Auch die Referenzen zur QWP Guideline und ICH Q11 und weitere zeigen erhebliche Inkonsitenzen und unklare Definitionen und Festlegungen.
So unterscheiden sich alleinig schon die Festlegungen, was zu einem Prozess und Lebenszyklus gehört, die unterschiedlichen Definitionen, sogar im Anhang 15 selbst. Zur Qualifzierung und Validierung wurde dann noch der Schritt der Verifizierung aufgenommen, ohne dies näher zu beschreiben. Es ist sicherlich empfehlenswert, dass zu allererst eine Festlegung der Definition eines Prozesses selbst erfolgen sollte. Die QWP Guideline beinhaltet beispielsweise im Anhang 1 ein sogenanntes Process Validation Scheme, das sehr sinnvoll ist, aber im Anhang 15 nicht direkt genannt wird. Der ICH Q11 gbit eine Control Strategy vor, die in einem Dokument “manufacturing process development” definiert sein soll.
In Kapitel 3.2 wird beispielsweise definiert, dass eine URS (für new facilities, systems or equipment) erzeugt werden muss, und dass die URS “should be a point of reference throughout the validation life cycle”. Dass aber die Anforderungen aus einer Prozessspezifikation erzeugt werden müssen, und demzufolge alle Prozesselemente (ob als System, Equipment, Gebäude, etc. definiert wären) entsprechend qualifiziert sein müssen, ist nur unzureichend formuliert. Als Lebenszyklus findet man diesen auf Produkte, Prozesse, Validierung und natürlich Daten. Ob dieses Dokument dann VMP genannt wird, und ob dies “pro Site” erzeugt wird, sollte nicht als eine Anforderung in den Annex 15 münden. Interessant könnten aber entsprechende Prozesse sein, die von externen Firmen (outsourced activities – Kapitel 7 EU GMP) durchgeführt werden. Die aktuelle Draft Version des Anhang 16 fordert hierfür ein “comprehensive diagram”, das ebenso als Grundlage zur Prozessvalidierung gelten sollte.
Ob nun einzelne Prozessschritte wie Reinigung und Transport, die natürlich wichtig sind, einzeln genannt werden müssen, auch noch in der Verbindung des Worts “Verification”, sollte diskutiert werden. Prozesse bestehen aus Prozesselementen und Prozesschritten, eigentlich über den gesamten Warenfluss (Ausgangsstoffe bis zum Fertigarzeimittel). Daher sollten Prozessbeschreibungen den gesamten Material-, Personal- und Datenfluss beinhalten, in den entsprechenden Umgebungen und Vorbedingungen.
Die aktuelle Draft Version beihaltet viele Punkte zur Diskussion und Bewertung. Daher nochmals unsere Empfehlung, damit die EMA Arbeitsgruppe die aktuelle Version verbessern kann:
Nutzen Sie unbedingt die Chance die Draft Version des Anhang 15 zu kommentierten.
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