Material Control. Comprising those employees engaged in the handling of stock, stock records, operation of Company automotive vehicles and the procurement of materials and parts required to support Technical Services.
Material Control. The Supplier shall have a material control system that identifies each item (lot, component, or part) to prevent improper use. Such identification shall relate the item to its design drawing, specification, or other descriptive information throughout its production, receipt, installation, repair, and/or modification. Throughout the manufacturing process, materials shall be controlled to prevent improper or inadvertent use.
Material Control. 4.3.1 Test Methods and Specifications [***] [***]
4.3.2 Material Destruction [***] [***]
4.3.3 Vendor Audit Responsibility [***] [***]
4.3.4 Client Furnished Materials [***] [***]
4.3.5 In-coming Material Testing [***] [***]
Material Control. 10 3.4 Manufacturing / Cleaning........................................11
Material Control. 3.3.1 INyX shall have written procedures to describe receiving, sampling, reconciliation, coding and inspection operations for all materials received and intended for use in Stiefel Products.
3.3.2 Raw Materiaxx (Xxtive and Excipient) and components used for the production of Stiefel Products shall be of the appropriate quaxxxx xx specified in approved specifications ( as specified by Stiefel and implemented by InyX) and be sourced from approved vendors. The procedures outlined in Section 2.4 shall be followed in the event that INyX is informed of any proposed processing changes to an active ingredient or a primary packaging component, and in the event that Stiefel proposes to change an Active Ingredient xx xxxipient supplier or primary packaging component. The procedures outlined in Section 2.5 shall be followed in the event that any non-conformance is encountered during the storage or control of raw materials, components, or finished Product.
3.3.3 INyX shall have clearly defined, labeled and secured areas for quarantined, rejected and approved materials, as appropriate. There shall be a well-defined written system for identification of materials according to Product type, lot number, and status.
3.3.4 Raw Material, bulk and finished goods storage conditions shall be determined by specification or Product labeling. Environmental controls or monitoring shall be in place to ensure compliance with appropriate storage conditions.
3.3.5 Raw Material retest frequencies and attributes shall be described in the appropriate raw material specification. INyX and Stiefel shall agree an SOP to be followed to extend the shelf-life of the raw material used for Stiefel Products.
Material Control. 4.3.1 Test Methods and Specifications
Material Control. 14.1. Lot Identity Materials manufactured at CYTOVANCE will be identified at CYTOVANCE using a CYTOVANCE batch record identifier (lot number or equivalent).
Material Control. Describe the system to be used for Material Control, providing data for the following areas:
1. Advanced CFM material ordering.
2. Receipt, inspection, and identification of GFM and CFM, including rotatable pool items.
3. Control of pilferable and sensitive material.
4. Control of damage and reporting system.
5. Turn-in material, including equipment shipped to subcontractors for work.
6. Scrap material and relative accounting system.
7. Ripout material which is to be reinstalled
8. Procedure for critical material decisions such as substitution.
9. Temporary issue of storeroom repair parts to support overhaul/availability. Show how the proposed system satisfies Production and QA Material Control requirements. Describe how material is distributed to the crafts.
Material Control. SUPPLIER shall have procedures in place for the receipt, identification, storage, handling, sampling, dispensing, testing/re-testing, disposition (i.e., approval, rejection, quarantine) and destruction of materials (i.e., excipients, Active Pharmaceutical Ingredient (API), packaging components, labeling components). Prior to its use in the manufacture of SUPERNUS’ PRODUCT, materials provided by SUPPLIER or SUPERNUS will be inspected, tested against current specifications and released by SUPPLIER against the SUPPLIER specification system. SUPERNUS will provide SUPPLIER with a copy of the API specification. ** This portion has been redacted pursuant to a confidential treatment request.
Material Control. Control and traceability of all materials used in the manufacture of the Products will be accomplished by adherence to internal SOPs.
