CFR Part 111 Current Good Manufacturing Practice (CGMP) Dietary Supplements Compliance Checklist
The CFR Part 111 Current Good Manufacturing Practices (CGMPs) Dietary Supplement Compliance Checklist is a complete auditing compliance checklist against the Final Rule published in June 2007. The audit checklist can be used by both manufacturers and suppliers of dietary supplements and dietary supplement ingredients. The compliance checklist can be used as a starting point for regulatory, internal, informal or third party audits against the new CGMPs and can be used to determine the readiness of a supplement manufacturer for a formal FDA site inspection. The Word form of the checklist can be tailored for specific uses and circumstances. The compliance checklist is a pivotal document for insuring that your organization complies with the new CGMPs for dietary supplements.
Provider: JKS & Associates
The complete checklist is over 70pages and covers each of the major areas of the new Dietary Supplement CGMPs.The sections include:
- General Provisions
- Personnel
- Physical Plant
- Equipment and Utensils
- Production and Process Control Systems
- Establish Production and Process Control System
- Requirements for Quality Control
- Requirements for Components, Packaging and Labels
- Requirements for the Master Manufacturing Record
- Requirements for the Batch Production Records
- Requirements for Laboratory Operations
- Requirements for Manufacturing Operations
- Requirements for Packaging and Labeling Operations
- Establish Production and Process Control System
- Holding and Distribution
- Returned Dietary Supplements
- Product Complaints
- Records and Record Keeping
The document comes in twoformats, Adobe Acrobat and Microsoft Word format. The Microsoft Word format canbe tailored or modified for special use, such as using only applicable sectionsfor specific suppliers. Both formats are configured with the actual CFR Sectionidentifier and the actual CFR section titles for easy reference and navigationand includes areas to declare conformance or non-conformance to the regulationsas well as adding auditing comments. See the sample page for an example of theactual compliance checklist.
Purpose:
- Provides a comprehensive framework for CGMP compliance for any type of dietary supplement organization or manufacturer.
- The compliance checklist provides an easy way to assess compliance to CFR Part 111 either informally or formally.
- Provides a method for quality organizations, regulatory groups and management to determine if any gaps in compliance exist.
Who Will Benefit:
- End users responsible for the various aspects of day to day production of dietary supplements
- Physical plant and maintenance personnel
- Operators of automated, mechanical or electronic manufacturing equipment
- Quality control and quality system personnel
- Laboratory and lab testing personnel
- Production and process control personnel
- Packaging and labeling personnel
- Manufacturing engineers and personnel
- Regulatory personnel
- Plant managers
- Quality system auditors
- Consultants
Why Purchase This Document:
- Ready to use out of the box
- Document is easy to read and understand
- Provides detailed audit guidance
- Complete section-by-section self audit checklists
- Can by customized and tailored (Word format only)
- Ready for immediate download and use
- Strong clear design and layout
- Fully compliant to CFR Part 111
- Will keep your internal and external audits against the new CGMPs organized and provide a way to track implementation and corrective actions.
- Will save the user dozens of hours in creating a similar auditing checklist
