Contract Manufacturing Quality Agreement Template

From both a regulatory and a commercial perspective, companies should cooperate with their suppliers (contract manufacturers) to ensure that they receive materials and services in accordance with quality, volume and delivery specifications. Some companies limit the supplier`s qualification process to the development of a supplier contract. However, this approach is generally insufficient when it comes to defining each party`s tasks, responsibilities and obligations with respect to product quality and testing. “The manufacture and analysis of orders must be properly defined, agreed and controlled to avoid misunderstandings that can lead to an unsatisfactory quality product or work. […] The contract must clearly state how the qualified person who releases any batch of product put up for sale assumes full responsibility” (extract from the rules on medicines in the European Union, Volume 4, good manufacturing practices, Chapter 7, manufacturing and order analysis). It contains nine cultivation tools that cover process details, materials, CPI, product specifications, stability, customers and labels. This ready-to-use model requires only a small amount of location-specific changes before you can fully accept it for your operations. All you need to do is enter your site-specific information into the marked colored fields. This master`s document model for technical quality manufacturing, over 35 pages in length, clearly defines the obligations of the contractor and the interdator and is extremely advantageous for both parties. The proposal contains all the necessary agreements, agreements and controls to avoid any misunderstanding that could lead to a product or work of unsatisfactory quality. 1 Subject to this agreement 1.1 Field of Application 1.2 Technical Information 2 Information and Management Responsibilities 3 Delivery and Manufacturing 3.1 Locals 3.2 cGMP Guidelines 3.3 Materials 3.3.1 Materials obtained by LESS 3.3.2 Materials: Batch numbering by CONTRACT GIVER 3 .4 Master Charge Record 3.5 3.6 Batch numbering 3.7 Manufacturing date 3.8 Reconditioning and preparation 3.9 Manufacturing and installation data 4 Assurance and quality control 4.1 Sample collection 4.2.1 Test 4.2 1 Packaging raw materials and components 4.2.2 Process Test 4.2.3 Finished Product 4.3 Release Procedure 4.4 Documentation 4.4.1 Documentation 4.4.2 First Three Lots 4.4.3 Requirements for Complete Documentation 4.

4.7 Refus du PRODUIT par CONTRACT GIVER 4.8 Conflit Résolution 4.8.1 Problèmes analytiques 4.8.2 Assurance et problèmes environnementaux 4.9 Inspections réglementaires 4.10 Contrôle annuel DES PRODUITS 4.11 Droit à l`examen 4.12 Mesures correctives provenant des audits 4.13 Post Marketing Issues 4.13.1 Défauts , die nach Genehmigung durch SUPPLIER 4.13.2 Produktbeschwerden 4.13.3 PRODUKTrückruf 4.13.3 PRODUKTrückruf festgestellt wurden 4.13.4 Medizinische Überwachung und unerwünschte Arzneimittelreaktionen/-ereignisse (ADR/E) 4.13.5 Kontakt mit Registrierungsstellen 5 Abweichungen und Untersuchungen 5.1 Abweichungen 5.2 Fehleruntersuchungen 6 Änderungskontrolle 7 Prozess und Analysefähigkeit – Validierung 7.1 Analytische Methodenvalidierung und Ausrüstungsqualifizierung 7.2 Reinigung 7.3 Facility and Utilities Qualification (DQ, IQ, OQ) 7.4 Prozessvalidierung (PQ) 8 Laboratories 8.1 Compliance 8.2 Equipment 8.3 Dokumentation 8.4 Vertragslaboratorien 9 Personal, Gesundheit & Sicherheit 9.1 Personal 9.2 Gesundheit, Sicherheit und Umwelt 10 Lagerung und Versand 10.1 Versand an CONTRACT GIVER 10.2 Versand an DIE Kunden von CONTRACT GIVER 11 Vertraulichkeit , Nutzungsbesbeschr-nkung 12 Gew-hrleistungen – Verbindlichkeiten- Entsch-digung 12.1 Gew-hrleistung12.2 Gew-hrleistungsausschluss 12.3 Beschrunkung der Rechtsbehelfe 12.4 Freistellung 13 Versicherung 13 Laufzeit, Kondigung, Wirkungen auf Kondigung 15 H-here Gewalt 16 Verschiedenes 16.1 Positionen 16.2 Abfindung 16.3 Verzicht 16.4 Abtretung 16.5 Mitteilung 16.6 Volls 16.7 Gegenst-cke 16.8 Beh-rde 17 Geltendes Recht – Streitigkeiten 17.1 Geltendes Recht 17.2 Zust-ndigkeit 18 TECHNISCHE INFORMATIONEN mit 9 Anhangen.