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FDA 21 CFR 820
Quality System Regulation QSR Requirements for Medical Device Manufacturers
21 CFR 820 applies to manufacturers of finished medical devices sold in the United States. This includes imported products. Only parts of the requirement may apply, depending on the class. WCH specializes in helping organizations meet the requirements of Parts 210 and 211. 21 CFR 820 can be integrated with ISO 13485, if desired.
Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing,
Packing, or Holding of Drugs
Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals
A successful cGMP project will require your company’s commitment to provide resources and complete goals and homework which arise as the result of the workshops shown in the menu below. WCH cannot stress enough how important it is for your company to commit to the project in order to be successful.
The following menu is representative of the consulting services that may be provided during an implementation project.
It is also possible to request any of these services separately on an as needed basis.
Current Good Manufacturing Practice
cGMP Gap Analysis
On-site visit to review current documents and processes, and to determine gaps between same and the requirements of The Standard.
cGMP Kick-off Meeting / Management Presentation
Staff Meeting to determine all processes in the organization and responsibilities for each.
The Presentation will focus on MANAGEMENT RESPONSIBILITY and COMMITMENT, which is essential for success of the Management System.
Review / Establish the company's Policy and Objectives.
cGMP Top Level Manual
Development / editing of a manual that establishes policies for all required elements of The Standard. There are items that need to be recorded in a centralized location. WCH believes the Manual is a good vehicle for accomplishing this. Additionally, in most companies, WCH finds that customers request a copy of the Manual in their "Supplier Surveys."
cGMP Procedure Development
Drafting the first version of flowcharts for all required processes (usually between 10 & 20), and ensuring the company can issue procedures to the system. Procedures will be developed in flowchart format using Microsoft Word. Where possible, the company’s existing documentation will be used and / or modified as necessary.
A meeting with the appropriate employees will be scheduled to draft the procedure or process. A second meeting may be held after each participant has had an opportunity to review the draft version. Changes required will be incorporated into the procedure or process before final review and approval.
cGMP Coaching and Consulting
On an as needed basis the WCH consultant will observe procedure steps and tasks, provide suggestions, and answer questions to ensure procedural documentation and corresponding actions taken by employees are mirror images.
cGMP Employee Understanding & Awareness Training
WCH will provide all employees with a basic overview of the system, the Standard requirements, their responsibilities and what to expect when the registrar conducts the Registration Audit.
cGMP Internal Auditor Training
A sound auditing program is vital to the health and continual improvement of the Management System. Internal System Auditors will be trained in the requirements of The Standard and process auditing techniques.
cGMP Second Party Internal Audit
In lieu of Internal Auditor Training, WCH Professional Services provides qualified Internal Audit support, performing value-added audits in a cost- and time- efficient manner.