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.
Emailed in PDF format
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.
Emailed in PDF format
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.
Emailed in PDF format
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.
Emailed in PDF format
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.
Emailed in PDF format
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.
Emailed in PDF format
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.
Emailed in PDF format
