SOP Pharmaceutical Management Controls

Pharmaceutical Standard Operating Procedure Template Group 100 contains PH10, PH11, PH12 and PH13 procedures, forms and log books.

Pharmaceutical Standard Operating Procedure Template- Defines the role and responsibility of the company Quality Unit. Applies to all GMP operations performed at the company, and defines responsibilities for all GMP operations or services performed by contract organizations. Package consists of the procedure, a Quality Systems Review Record and a Quality systems Activities Log. To view a sample page from this SOP template Click Here.

Pharmaceutical Standard Operating Procedure Template- Describes the process and instructions for performing Internal Audits to assess the Quality Systems performance, assure it is in compliance with established requirements, Current Good Manufacturing Practices and is operating effectively. Package consists of the procedure, an Internal Audit Report and an Internal Audit Schedule Log.

Pharmaceutical Standard Operating Procedure Template- Describes the process for managing visits or inspections by regulatory agencies having legal authority over drugs manufactured or distributed by the company. Package consists of the procedure, a Regulatory Agency Daily Visit Record and a Regulatory Agency Visit Log.

Pharmaceutical Standard Operating Procedure Template- Describes a system that assures that all personnel are adequately trained to properly perform their assigned responsibilities. Package consists of the procedure, a Training Attendance Record, an Employee Training Plan and an Employee Training Record Log.