CONTROLLED DOCUMENTS. Paper or electronic documents that are part of the quality system and contain data/information required by cGMPs. These documents may also be referred to as GMP documents. Such documents must be initiated and revised through document control and/or change control procedures. Examples of controlled documents are: SOPs, analytical test methods, specifications, batch records, validation protocols, forms, etc.
Appears in 2 contracts
Sources: Commercial Manufacturing and Supply Agreement (Ophthotech Corp.), Clinical Manufacturing and Supply Agreement (Ophthotech Corp.)