PH10 RESPONSIBILITIES OF THE QUALITY UNIT SOP Template
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.
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PH11 INTERNAL AUDITS SOP Template
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.
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PH12 REGULATORY AGENCY INSPECTION SOP Template
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.
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PH13 PERSONNEL TRAINING PROGRAM SOP Template
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.
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PH22 DOCUMENT AND CHANGE CONTROLS SOP Template
Pharmaceutical Standard Operating Procedure Template- Describes the process, procedures and requirements for controlling documents and changes to assure that documents and changes are adequately evaluated, reviewed and approved prior to implementation. Package consists of the procedure, a Document Change Order, a Change Control Board Record, a Document Change Index Log and a Change Control Board Index Log.
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PH23 GOOD DOCUMENTATION PRACTICES SOP Template
Pharmaceutical Standard Operating Procedure Template- Describes the company's cGXP documentation practices and describes the process for completing cGXP documents, correcting errors, assigning significant figures, rounding errors, verification of data entries, calculations and other document entries. Package consists of the procedure.
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PH30 CORRECTIVE AND PREVENTIVE ACTION SOP Template
Pharmaceutical Standard Operating Procedure Template- Describes the systematic approach used to collect and analyze information, identify and investigate product and quality issues, and take appropriate and effective corrective and preventive action to resolve product and quality issues and prevent their recurrence. This procedure also discusses the communication and documentation activities associated with the corrective and preventive action system. Package consists of the procedure, a Corrective and Preventve Action Report and a Corrective and Preventive Action Report Log.
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PH32 PRODUCT RECALLS SOP Template
Pharmaceutical Standard Operating Procedure Template- Describes the requirements and process for recalling a distributed product from customer or users for products manufactured by or for the company. Package consists of the procedure, a Recall Action Report and a Recall Action Log.
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PH34 COMPLAINT HANDLING SOP Template
Pharmaceutical Standard Operating Procedure Template- Describes the process for receiving, reviewing, and evaluating complaints and describes the responsibilities associated with the complaint handling process. This procedure also describes some elements of the customer communication and feedback process. Package consists of the procedure, a Complaint Report, and a Customer Contact and Complaint Log.
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PH35 QUALITY INVESTIGATIONS SOP Template
Pharmaceutical Standard Operating Procedure Template- Describes the procedure for documenting an exception report. This is a failure to meet predetermined material, product, process, facilities, equipment or system requirements or an observation or a trend that could potentially affect product quality. In addition, the exception report may require further action, a quality investigation and/or further action. Package consists of the procedure, an Exception Report, a Quality Investigation Checklist and an Exception Log.
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PH36 ANNUAL PRODUCT REVIEWS SOP Template
Annual Product Review Pharmaceutical Standard Operating Procedure Template
Describes the company's procedure for performing an annual product review of all product lots and related documentation to evaluate the quality standards of each drug product and to determine the need for changes in product specifications and methods, manufacturing processes, or control procedures. Package consists of the procedure, an Annual Product Review Summary and an Annual Product Review Recommendations Log.
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PH37 QUALITY RISK MANAGEMENT SOP Template
Pharmaceutical Standard Operating Procedure Template- Describes the company's process to be used in conducting a risk assessment. This document provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceuticla quality. These aspects include developemnt, manufacturing, distribution, inspection and submission throughout the lifecycle of drug substances, products and components. Package consists of the procedure.
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PH38 MANAGEMENT REVIEW SOP Template
Pharmaceutical Standard Operating Procedure Template- Describes the process for executive management to review the results of quality audits, material, process and product performance, and key quality metrics in order to monitor and measure the effectiveness of the company's quality system and performance against corporate goals and objectives. Package consists of the procedure and a Management Review Agenda.
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PH40 CALIBRATION AND PREVENTIVE MAINTENANCE SOP Template
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.
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PH41 BUILDING FACILITY SANITIZATION SOP Template
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.
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