SOP Medical Device Production and Process Controls

Medical Device Standard Operating Procedure Template Group MD400 consists of MD40, MD41, MD42, MD46, MD47, MD48 and MD49 procedures, forms and log books.

Medical Device Standard Operating Procedure Template- Describes the procedures for ensuring that inspection, measuring, test and process equipment are routinely calibrated, inspected, checked and maintained to ensure fitness for use. Package consists of the procedure, a Calibration and Preventive Maintenance Report, a New Equipment form and a Master Equipment List Log.

Medical Device Standard Operating Procedure Template- Describes the procedures for cleaning and sanitizing building, facilities and clean rooms used in the manufacture, processing, packaging, or holding of the product in order to control and prevent product contamination. Package consists of the procedure, an Area Cleaning Record and an Area Cleaning Log.

Medical Device Standard Operating Procedure Template- Describes the procedures for use of rodenticides, insecticides, fungicides, or fumigating agents to prevent pest infestations in facilities used in the manufacture, processing, packaging and holding of the product. Package consists of the procedure, a Pest Control Inspection Record, a Pest Control Treatment Record, and a Pest Control Activities Log.

Medical Device Standard Operating Procedure Template- Describes and documents company policies and procedures for validation activities related to facilities, utilities, processes, equipment, tooling, test methods and materials which directly or indirectly affect products distributed commercially by the company. Package consists of the procedure, a Validation Protocol, a Validation Report and a Process Validation Index Log.

Medical Device Standard Operating Procedure Template- Describes the system to assure that all finished products are released for distribution only after verification of conformance to all applicable manufacturing, quality and regulatory requirements including conformance with the Device Master Record. Package consists of the procedure, a Finished Product Release Record and a Finished Product Release Log.

Medical Device Standard Operating Procedure Template- Describes software development and validation activities to ensure that software complies with established software requirements and satisfies its intended use. Package consists of the procedure and a Software Validation Index Log.

Medical Device Standard Operating Procedure Template- Describes the methods used in the development, conduct, control and monitoring of production processes for products intended for commercial distribution at the company. Package consists of the procedure, a Work Order form and a Work Order Log.