DOCUMENT CHANGE PROCEDURE Sample Clauses
DOCUMENT CHANGE PROCEDURE. Chiron, in its sole discretion, will determine whether or not to modify BPDs, MPDs and/or SOPs to incorporate changes to specifications and procedures requested by BMPI. Any such modifications will be charged at the Additional Services Rate. Chiron will notify BMPI prior to implementing any change that reasonably would be expected to have an impact on the process, procedures, facilities, equipment, systems, starting materials, ingredients, packaging or testing materials involved in the production or testing of Product. TABLE 3.2: PROCEDURES ILLUSTRATIVE ONLY CHIRON: -------------------------------------------------------------------------------- PROCEDURE # TYPE PROCEDURE TITLE -------------------------------------------------------------------------------- ANALYTICAL -------------------------------------------------------------------------------- ** -------------------------------------------------------------------------------- MANUFACTURING -------------------------------------------------------------------------------- ** -------------------------------------------------------------------------------- GENERAL -------------------------------------------------------------------------------- ** -------------------------------------------------------------------------------- ** REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
DOCUMENT CHANGE PROCEDURE. This procedure first defines the classes of changes; then describes the mechanics of the change process based on those classifications per SeaMED's Internal Quality Assurance requirements.
2.1. Document classifications; Documents may be described as either generic or product-specific. The generic category includes Source and Specification Control Drawings (SCD) used for buying and inspecting commercially available "off-the-shelf" parts. Product-specific documents include all documents that are unique to the design of the product.