Standard Operating Procedure Templates - SOPs

We provide high quality good manufacturing practice (gmp) documents and templates for the regulated health industry.
Our main expertise is the Quality Management field for drug products, drug substances (active pharmaceutical ingredients, API), medical devices and the ISO regulated industry.
Our Quality Management documents and standard operating procedure templates are built on the industry specific requirements and regulations.
Conformance of our documents is our first goal.
All templates and forms are in compliance with FDA (USA) and EMEA (European) regulations.
Using one of our standard operating procedure template (SOP template) will save you money and time due to the quick and easy adaptation according to your needs.

New Products

Change Control SOP

This Standard Operating Procedure (SOP) for a well structured Change Control Process is ready to use and meets authorities’ expectations. The 10-page SOP includes a 2 pages template and only needs some minor modification before it can be followed by your personnel and guarantees an effective Change Control system.

$110.00
CAPA Management

This Standard Operating Procedure (SOP) describes the program necessary for the Corrective and Preventive Action (CAPA) Program. The purpose of this document is to provide clear guidance for Quality and personnel working in a GMP environment when conducting CAPAs. The CAPA system in addition assures the tracking and trending of actions and issues requiring mid-term and long-term corrective actions. This procedure will provide guidance on the requirements and the use of the system as well as the procedure for processing CAPAs.

$180.00
Complaint Handling - Customer Complaints

This Standard Operating Procedure (SOP) describes the Complaint Handling program, all necessary steps, starting from the notification recording, investigation and subsequent actions, which must be carried out for any customer complaint received.

$190.00
Deviations and Non-Conformances SOP

This Standard Operating Procedure (SOP) describes the program necessary to ensure that all Deviations are documented, investigated within 30 working days, assessed by the responsible line units and Quality Assurance (QA), corrective actions if applicable are implemented and implementation is tracked, the complete process is managed, monitored and controlled.

$160.00

Supplier Approval, Qualification and Certification SOP

This Standard Operating Procedure (SOP) describes the program necessary to ensure qualifying a supplier is to assess the supplier’s reliability, continuous quality of products and services and the overall effectiveness of the supplier’s quality assurance system. This SOP describes the complete process in a step-by-step approach to qualify a supplier from an approved to a certified status.

$120.00
Risk Management Process

This Standard Operating Procedure (SOP) describes in detail all the key steps to implement an reliable and effective Risk Management Program. This program is a requirement by the agencies not mattering if FDA or EMA. It is essential to identify, mitigate and control risks associated with the development medical devices.

$210.00
Vendor, Supplier and Contractor Audit
This procedure pertains to GMP related Audits of suppliers of raw materials, excipients or components, drug products, drug substances and medical devices, contract manufacturing and services, contract laboratory testing, contract packaging or labeling facilities. All of these service providers are called in the SOP “suppliers”.

$180.00
Preventive Maintenance

This Standard Operating Procedure (SOP) describes the Process on how to manage the Preventive Maintenance Program. The SOP describes the processes for requesting, conducting and managing the overall Preventive Maintenance (PM) activities.

$120.00

Design Control SOP

This Design Control Standard Operating Procedure (SOP) is ready to use and meets the expectations of a structured development by guiding the design efforts through well defined input and output phases. The 11-page SOP only needs some minor manufacture or design center specific modification before it can be used for your development.

$220.00
Quality Product Review / Annual Product Review

This Standard Operating Procedure (SOP) describes the program necessary when conducting the Annual Product Review (APR) which must be performed for each commercial product. The purpose of this SOP is to provide clear guidance on how to perform an APR with the purpose to verify the consistency of the process, to assess trends, to determine the need for changes in specifications, production, manufacturing, and/or control procedures and to evaluate the need for revalidation.

$190.00
SOP on Standard Operating Procedures

This Standard Operating Procedure (SOP) describes the Process on how to write SOPs. Standard Operating Procedures (SOPs) must be written, approved and followed for any routine operation, activity or task that may impact the safety, quality, purity and efficacy or distribution of active pharmaceutical ingredient, pharmaceutical product (i.e. drug product) or medical devices to ensure consistent application and meet regulatory compliance. The purpose of this Standard Operating Procedure (SOP) is to standardize and systematize the creation, revising, approving and issuing of Standard Operating Procedures.

$150.00
Management Review for Medical Devices

This Standard Operating Procedure (SOP) defines and describes the Management Review process, to monitor and verify the implementation of the Management System.

This assures the sustainability, suitability and effectiveness of the whole Quality Management System for medical devices and its compliance to satisfy ISO 13485 and 21CFR 820.

$160.00

Standard Operating Procedure Template - SOP Template

This is an empty SOP template to create site specific standard operating procedures. It contains all relevant section headers of an up to date operating procedure.

$9.00
Medical Device Design Verification SOP

This Standard Operating Procedure (SOP) describes the procedures verifying a Product’s design through appropriate inspection, testing, analysis, and review. This Verification ensures the Product Requirements, which are defined during the Design Input phase of Design Control, have been met.

$190.00
Medical Device Design Validation SOP

This Standard Operating Procedure (SOP) describes the program necessary to validate the design of COMPANY products against User Requirements. This Standard Operating Procedure (SOP) describes the This SOP is part of the COMPANY Design Control Program, as outlined in the Design Control SOP.

$220.00