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Standard Operating Procedure Templates

GMProcedures are time saving SOP Templates that cover the essential elements of a Quality Management System. These SOP Templates can be edited by you to cover your specific operations and practices, and will save you weeks of preparation time. Each SOP Template includes the procedure, one of more reporting forms, and a log book, Our SOP's are organized into five compliance groups:

  • Management Controls
  • Design and Document Controls
  • Corrective and Preventive Action
  • Production and Process Controls
  • Material Controls

GMProcedures are Designed for Medical Device and Pharmaceutical Manufacturers

These SOP templates provide the framework for a Quality System by combining procedures, reports for evidence of compliance, and log books to track compliance histories. These SOP's will provide a foundation for compliance with FDA Quality System Regulations and ISO standards and serve as a prototype for you to customize to your individual situation.

Easily Customized to Your Needs

GMProcedures are supplied on a CD. The SOP Templates, reports and log books are all furnished in Microsoft Word so that you can easily edit them to your specific requirements.

Time Saving SOP Templates

GMP Labeling has supplied SOP templates to the health care industry for 22 years, expanding their scope and adding procedures to reflect trends in both the regulations and in the industry over that time. Our SOP's include references and links to important industry guidance documents.

View Medical Device Manufacturers SOP's
View Pharmaceutical Manufacturers SOP's

These SOP templates are simple to use and will save you weeks of work.

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MANAGEMENT CONTROLS SOP Templates Group MD100 MANAGEMENT CONTROLS SOP Templates

Medical Device Standard Operating Procedure Template Group MD100 contains MD10, MD11, MD12 and MD13 procedures, forms and log books.

Price: $375.00
DESIGN AND DOCUMENT CONTROLS SOP Templates Group MD200 DESIGN AND DOCUMENT CONTROLS SOP Templates

Medical Device Standard Operating Procedure Template- Group MD200 contains MD20, MD21, MD22, MD23, MD24, MD25 and MD26 procedures, forms and log books.

Price: $645.00
CORRECTIVE AND PREVENTIVE ACTION SOP Templates Group MD300 CORRECTIVE AND PREVENTIVE ACTION SOP Templates

Medical Device Standard Operating Procedure Template; Group MD300 consists of MD30,MD31,MD32, MD33,MD34 and MD35 procedures, forms and log books.

Price: $555.00
PRODUCTION AND PROCESS CONTROLS SOP Templates Group MD400 PRODUCTION AND PROCESS CONTROLS SOP Templates

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

Price: $645.00
MATERIAL CONTROLS SOP Templates Group MD500 MATERIAL CONTROLS SOP Templates

Medical Device Standard Operating Procedure Template Group MD500 consists of MD50, MD51, MD52, MD54, MD55, MD56, MD57, MD58, and MD59 procedures, forms and log books.

Price: $825.00
QUALITY UNIT RESPONSIBILITY SOP Templates Group PH100 QUALITY UNIT RESPONSIBILITY SOP Templates

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

Price: $375.00
DESIGN AND DOCUMENTS CONTROL GROUP SOP Templates Group PH200 DESIGN AND DOCUMENTS CONTROL GROUP SOP Templates

Pharmaceutical Standard Operating Procedure Template Group 200 contains PH22 and PH23 procedures, forms and log books.

Price: $235.00
CORRECTIVE AND PREVENTIVE ACTIONS SOP Templates Group PH300 CORRECTIVE AND PREVENTIVE ACTIONS SOP Templates

Pharmaceutical Standard Operating Procedure Template Group 300 contains PH30, PH32, PH34, PH35, PH36, PH37 and PH38 procedures, forms and log books.

Price: $645.00
PRODUCTION AND PROCESS CONTROLS SOP Templates Group PH400 PRODUCTION AND PROCESS CONTROLS SOP Templates

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

Price: $825.00
MATERIALS CONTROLS SOP Templates Group PH500 MATERIALS CONTROLS SOP Templates

Pharmaceutical Standard Operating Procedure Template Group 500 contains PH50, PH51, PH52, PH53, PH54, PH55, PH56 and PH57 procedures, forms and log books.

Price: $735.00
MANAGEMENT RESPONSIBILITY SOP Template MD10 MANAGEMENT RESPONSIBILITY SOP Template

Medical Device Standard Operating Procedure Template- Describes the responsibilities of Executive Management for establishing, implementing and maintaining the Quality Management System, reviewing the suitability and effectiveness of this system, and providing resources to implement this system, maintain its effectiveness, and meet regulatory and customer requirements. Also describes management's responsibility for Risk Management and customer requirement related activities. Package consists of the procedure, a Management Activities Log and a Management Review Record form..

Price: $189.00
INTERNAL QUALITY AUDIT SOP Template MD11 INTERNAL QUALITY AUDIT SOP Template

Medical Device Standard Operating Procedure Template- Describes the process and instructions for performing Quality Audits to assess the Quality Management System performance, assure it is in compliance with established requirements, and is operating effectively. Package consists of the procedure, a Quality Audit Nonconformance Report, an Internal Quality Audit Report, and a Quality Audit Log.

Price: $189.00
REGULATORY AGENCY INSPECTION SOP Template MD12 REGULATORY AGENCY INSPECTION SOP Template

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

Price: $189.00
PERSONNEL TRAINING PROGRAM SOP Template MD13 PERSONNEL TRAINING PROGRAM SOP Template

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

Price: $189.00
DESIGN CONTROLS SOP Template MD20 DESIGN CONTROLS SOP Template

Medical Device Standard Operating Procedure Template- Describes the requirements for the Design Control System which ensures that devices are designed to meet user needs, intended uses, and specified requirements. Package consists of the procedure and a Design Review Report form.

Price: $189.00
DEVICE MASTER RECORD SOP Template MD21 DEVICE MASTER RECORD SOP Template

Medical Device Standard Operating Procedure Template- Describes the organization, content, creation and use of the Device Master Record employed in the production of all medical devices distributed by the company. Package consists of the procedure and a Device Master Record Index Log.

Price: $189.00
DOCUMENT AND CHANGE CONTROLS SOP Template MD22 DOCUMENT AND CHANGE CONTROLS SOP Template

Medical Device Standard Operating Procedure Template- Defines the system and assigns responsibilities for the control of documents pertaining to the Quality Management System at the company. Package consists of the procedure, a Document Change Order form, a Document Change Index Log, a Control Number Log, and a Document Change History Log.

Price: $189.00
RISK MANAGEMENT SOP Template MD23 RISK MANAGEMENT SOP Template

Medical Device Standard Operating Procedure Template- Defines and documents processes for addressing device related risks associated with the use and/or handling of the device in order to eliminate, or reduce to acceptable risks associated with the use and/or handling of devices manufactured or distributed by the company. Package consists of the procedure, a Risk Management Plan form, a Risk Management Summary Table, and a Risk Management File Index Log.

Price: $189.00
CONTROL OF RECORDS SOP Template MD24 CONTROL OF RECORDS SOP Template

Medical Device Standard Operating Procedure Template- Defines the policy of storage, access, preservation, recovery and purging of Quality System Records generated by or for the company.

Price: $189.00
GOOD DOCUMENTATION PRACTICES SOP Template MD25 GOOD DOCUMENTATION PRACTICES SOP Template

Medical Device Standard Operating Procedure Template- Describes the company's documentation practices and describes the process for completing Quality System Records, correcting errors, assigning significant figures, rounding numbers, verification of data entries, calculations and other document entries. .

Price: $189.00