Standard Operating Procedure Template
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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 -
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 -
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 -
Product Recall Management
This Standard Operating Procedure (SOP) describes the program necessary to assure that a product recall is conducted prompt, complete and in accordance with any governmental health agencies regulations and requirements of distributed product that is suspected or known by management to be seriously defective, and/or pose potential health risk to patients.
$180.00
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Internal Audit
This Standard Operating Procedure (SOP) describes the program necessary to assure compliance with all relevant GMP and Regulatory Requirement. Therefore this SOP defines the procedure and responsibility for the Internal Audit (Self-inspection) planning, implementation and follow-up to assure Site’s compliance with regulatory, cGMP and Site quality procedures.
$140.00 -
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 -
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 -
Training Program SOP
This Standard Operating Procedure (SOP) describes the Training program for Company personnel to acquire the skills, knowledge and qualifications necessary to perform effectively the duties and tasks for which they are employed.
$130.00
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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 -
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 -
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 -
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.
$5.00
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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 -
Development Project Initialization and Design Review
This Standard Operating Procedure (SOP) describes the Design Review requirements associated with a specific design project and is intended to ensure that a design satisfies the requirements for the intended use of a product and meets the needs of the user. This SOP is part of the COMPANY Design Control Program, as outlined in the Design Control SOP.
$180.00
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Is FDA turning into a profit center?
The FDA commissioner, Dr. Margaret “Peggy” Hamburg went into action after nomination with changes to be applied at the FDA. The commissioner today is under high pressure by the congress on the one hand and the public on the other hand. The economic crisis in the US as well as the forthcoming 2012 election of the US president has put enforcement on top of the FDA’s agenda. It is recognized by industry that FDA is much more quickly posting a warning letter after an unsatisfactory inspection. Consent decrees will not be fare a way any longer if persistent violations are proven. Currently there are many cases in the industry of well known companies which struggle well knowing that a warning letter or consent decrees will have a critical impact on reputation, sales, product availability on the market as well as companies share price. As a consequence it is even more important for the industry to meet the FDAs expectations by having founded and implemented a robust GMP Quality Management System and to take inspection preparation and management back to the top priority goals of the company.
