FDA Two-Track GMP Inspection Strategy Compliance Program Template
The FDA Two-Track GMP Inspection Strategy Compliance Program Template is a comprehensive tool designed to help pharmaceutical companies comply with the FDA’s Good Manufacturing Practice (GMP) regulations. This template is a Word document that can be easily customized to fit the specific needs of your organization.
The FDA Two-Track GMP Inspection Strategy Compliance Program Template is based on the FDA’s two-track inspection strategy, which focuses on both compliance and risk-based inspections. This template includes all the necessary elements to ensure that your organization is prepared for both types of inspections.
The template includes a detailed overview of the FDA’s GMP regulations, as well as a comprehensive checklist of all the requirements that must be met. It also includes templates for standard operating procedures (SOPs) and forms that can be easily customized to fit your organization’s needs.
The FDA Two-Track GMP Inspection Strategy Compliance Program Template is designed to help your organization achieve and maintain compliance with the FDA’s GMP regulations. By using this template, you can ensure that your organization is prepared for both compliance and risk-based inspections, and that you have all the necessary documentation in place to demonstrate your compliance.
Overall, the FDA Two-Track GMP Inspection Strategy Compliance Program Template is an essential tool for any pharmaceutical company that wants to ensure compliance with the FDA’s GMP regulations. With its comprehensive checklist, customizable templates, and detailed overview of the regulations, this template is the perfect solution for any organization looking to achieve and maintain compliance.
FDA Two-Track GMP Inspection Strategy Compliance Program Template
The FDA Two-Track GMP Inspection Strategy Compliance Program Template includes information regarding mandatory points to be evaluated, Track I and Track II inspections, and instructions for reviewing records. During the inspection, the investigator will record observations of areas inspected on form FDA 483. The areas to be inspected will depend on the circumstances of the investigation. For Class I devices, complaint files and MDR will usually be all that is investigated unless major problems are discovered.
The Two Track strategy requires a comprehensive GMP inspection (i.e., a complete systems audit of the quality assurance program) every four years and a limited GMP inspection at the intervening two year mark if, and only if, the firm at the two year mark meets the conditions specified in this Compliance Program.
FDA Two-Track GMP Inspection Strategy Compliance Program Template Details
Pages: 07
Words: 1860
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: Business Sampler
Category: Manufacturing
Procedure: FDA Inspections Procedure MFG104
Type: Guide
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