SOP Pharmaceutical Production and Process Controls

Pharmaceutical Standard Operating Procedure Template Group 400 contains PH40, PH41, PH42, PH43, PH44, PH45, PH46, PH47 and PH48 procedures, forms and log books.

Pharmaceutical Standard Operating Procedure Template- Describes the procedures for ensuring that inspection, measuring, test and process equipment used in GMP manufacturing 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, a Master Equipment List Log and an Equipment Use Log.

Pharmaceutical Standard Operating Procedure Template- Describes the control, preparation and use of cleaning, sanitizing agents in areas such as clean rooms and delineates the steps for sanitization of controlled and non controlled areas. Package consists of the procedure, an Agent Inspection Record, a Controlled Area Cleaning Record, an Agent Preparation Log and a Controlled Area Cleaning Record Log.

Pharmaceutical Standard Operating Procedure Template- Describes the procedures used for pest control at the company. Package consists of the procedure, a Pest Control Treatment Agent Record and a Pest Control Inspection Treatment Record.

Pharmaceutical Standard Operating Procedure Template- Describes the procedures for proper cleaning and maintenance of manufacturing equipment used in GMP manufacturing at the company including areas such as clean rooms. Package consists of the procedure and an Equipment Cleaning Storage and Use Log.

Pharmaceutical Standard Operating Procedure Template- Describes the procedures to establish production records pertaining to the accurate addition and documentation of the labeled or established amount of controlled materials in a production batch or drug product. Package consists of the procedure, a Controlled Material Dispensing Record, and a Controlled Materials Inventory Log.

Pharmaceutical Standard Operating Procedure Template- Describes the processes for receipt, inspection, storage, testing and release of controlled materials for GMP manufacturing at the company. Package consists of the procedure, a Controlled Materials Receipt and Inspection Record, a Controlled Material Disposition Record and a Controlled Material Status Log.

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

Pharmaceutical Standard Operating Procedure Template- Describes the procedure for the evaluation and disposition of API, intermediates and finished product maunfactured by the company. Package consists of the procedure, a Batch Record Review Checklist, a Batch Disposition Record, a Release Certificate and a Finished Product Log.

Pharmaceutical 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, a Software Validation Protocol, a Software Validation Report and a Software Validation Index Log.