PRODUCT DEVELOPMENT REPORT WITH PLAN(2).pptx

PRODUCT DEVELOPMENT PLAN

1. Post-approval labelling changes

2. Post-approval labeling changes refer to modifications made to the labeling of a product after it has received regulatory approval. These changes can range from minor adjustments like font updates to more significant alterations impacting the product's description or usage. 

3. Types of Post-Approval Labeling Changes: Minor changes: These typically include updates to font size, color, or design that do not affect the product's information.  Moderate changes: These may involve updates to product description, dosage instructions, or warnings, requiring notification to the regulatory body before distribution. 

4. Major changes: These changes impact the product's safety, efficacy, or quality and require prior approval from the regulatory body. 

5. Examples of Post-Approval Labeling Changes: Updating product information to reflect new clinical trial results. Changing the dosage instructions based on new research. Adding or updating warnings or precautions. Modifying the packaging design while maintaining the same product information. 

6. Regulatory Requirements: Prior Approval:  Major changes generally require prior approval from the regulatory body.  Notification:  Moderate changes typically require notification to the regulatory body before implementation.  Annual Reporting:  Minor changes are often reported annually. 

7. Why Post-Approval Changes are Necessary: Ensuring product safety and efficacy:  Regulatory changes can necessitate updates to product labeling.  Reflecting new scientific evidence:  New research may lead to changes in product information or warnings.  Improving clarity and patient understanding:  Labeling updates can enhance the clarity and accessibility of information for patients and healthcare professionals. 

8. Life cycle management It is the process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal

9. Establishment Inspection Report (EIR) Detailed document created by inspectors after visiting and inspecting a company's facility . It outlines the findings of the inspection, including observations of objectionable conditions and the establishment's responses to those findings. The EIR is used to assess compliance with regulations and identify potential risks, and it is typically available to the inspected company within 30 working days. 

10. Purpose and Content: Compliance Assessment: The EIR helps determine if a facility is meeting regulatory standards and identifies areas where improvements may be needed.  Risk Identification: It can reveal potential hazards or issues that could impact the quality or safety of products.  Action Planning: The EIR provides information for both the FDA and the inspected company to take corrective or preventative actions . Documenting Observations: The report details any non-compliance issues found during the inspection, including observations recorded on the Form FDA 483 (483).  Management Response: It includes the establishment's responses to the observed issues, outlining the steps they have taken or plan to take to address them.  

11. Key Features: Report Number and Date:  Identifies the specific inspection and its date. Inspection Type:  Indicates whether it was a PSI ( Post-Shipment Inspection) or a shop inspection. Client and Supplier Information:  Lists the involved parties in the inspection. Document Details:  Includes information like inspection order file number, purchase order number, and other relevant documents. Inspection Details:  Details the location of the inspection, the means of transport, and the scope of the inspection. Quality and Quantity Check:  Describes the methods used for verifying the quality and quantity of goods inspected. 

12. Availability and Use: To the Inspected Firm: The EIR is typically provided to the inspected establishment within 30 working days of the inspection's closure.  Public Access: EIRs are generally disclosable under the Freedom of Information Act (FOIA) and can be requested by the public.  FDA Review: The EIR is reviewed by the responsible FDA center or district office to determine the appropriate course of action.  Inspection Classification: Based on the EIR findings, the FDA may assign a classification to the inspection, such as NAI (No Action Indicated), VAI (Voluntary Action Indicated), or OAI (Official Action Indicated).