Vaccine post approval for industry for biological products 2013
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This notice clarifies requirements for submitting post-approval changes to biological products licensed in India. Manufacturers must submit an updated product profile dossier on a yearly basis compiling all changes made after initial approval. The updated dossier must include any changes approved by or notified to the regulatory authority. Additionally, no change impacting a biological product's quality can be implemented before approval from the authority. All manufacturers are instructed to submit an updated dossier adhering to the specified guidance within 15 days.
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The document discusses scale up and post approval changes (SUPAC) for generic drug applications. It defines SUPAC as changes made to a drug's composition, manufacturing process, equipment, or site after approval. The FDA modernization act of 1997 established four categories for reporting post-approval changes - prior approval, 30-day notice, immediate implementation, and annual report. The FDA has issued SUPAC guidance documents that describe what types of changes require validation studies or prior approval versus those allowable without notice. Post-marketing surveillance is also required to monitor adverse drug events after approval.
Supac
The document discusses SUPAC (Scale-Up and Post-Approval Changes) guidances issued by the FDA for pharmaceutical manufacturing process changes. It provides an overview of existing SUPAC guidances for immediate-release solid oral dosage forms and nonsterile semisolid dosage forms. The document also describes three levels of changes - Level 1, Level 2, and Level 3 - with varying test documentation and filing requirements based on the type and extent of manufacturing changes. Guidance documents for other dosage forms are still under development.
Scale up process and post marketing survilence
This document discusses scale up process approval changes and post marketing surveillance. It defines scale up as increasing batch size from research to production. It describes SUPAC guidelines which define levels of changes (minor, moderate, major) and required tests and documentation. The guidance provides recommendations for changes to composition, manufacturing site, batch size, and process. It also discusses post marketing surveillance methods like controlled trials, spontaneous reporting, cohort and case control studies to identify adverse drug effects. Manufacturers must establish standard operating procedures for post marketing surveillance.
Good clinical practices tutorial-june-21-09 shehnaz-v7.0
The document provides an overview of clinical trial regulations in India, China, and Russia. It discusses key aspects of India's regulatory history and framework, including important definitions, the roles of regulatory agencies like CDSCO and DCGI, clinical trial application requirements, and current applicable regulations like Schedule Y and GCP guidelines. It also briefly outlines the agenda for a discussion on practical experiences with QA audits in these countries.
documentation in pharmaceutical industry
This document discusses documentation in the pharmaceutical industry, including scale-up and post-approval changes (SUPAC), post-marketing surveillance, and outsourcing bioavailability and bioequivalence studies to contract research organizations (CROs). It covers SUPAC guidelines for minor, moderate, and major changes. It also discusses current requirements for post-approval changes involving components, manufacturing sites, batch size, and processes. The document reviews methods of post-marketing surveillance and sources of information. Finally, it provides an overview of reasons for outsourcing studies to CROs and factors to consider when identifying appropriate CRO capabilities.
regulations for combination products .
Combination product includes:
(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
(2) Two or more separate products packaged together in a single package or as a unit .
(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose;
CMC , POST APPROVAL CHANGES.pptx
The document discusses the roles and responsibilities of chemistry, manufacturing, and controls (CMC) regulatory affairs professionals. CMC ensures that pharmaceutical products are manufactured according to good manufacturing practices and that facilities meet regulatory standards. CMC regulatory affairs professionals work with various teams to provide CMC strategy, submit required information to regulatory agencies for approvals, and make submissions for any post-approval changes or studies. They act as responsible agents and certify that submissions meet all requirements.
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supplementalnewdrugapplication-200808084708 (1).pdf
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Good clinical practices tutorial-june-21-09 shehnaz-v7.0
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Vaccine post approval for industry for biological products 2013
- 1. t Fi Ie no. X 11026/306/11-BD Central Drug Standard Control Organization Directorate General of Health Services Office of Drugs Controller General (India) (Biological Division) DATE: 1 8 JAN 2013 NOTICE Clarification and requirements related to Post approval changes as per CDSCO Guidance for Industry for Biological Products. This is in reference to the implementation of Guidance for Industry posted on COSCO website for evaluation of various applications of post approval changes/variations for Biological Products. In order to update the Quality information of already licensed products in a systemic approach it has been decided to submit the updated PPD of all approved Biological Product on yearly basis having all changes compiled in Quality information. The updated PPO for all approved Biological drug products should include following information:- • All subsequent supplement and notifiable changes implemented after obtaining approval from this Directorate. • All subsequent minor changes intimated to this directorate which doesnot requires approval from OCG(I). This is further clarified that all subsequent applications made after obtaining Market Authorization from DCG(I) should be applied under Post approval changes as per requirements of Guidance for Industry (PAC/1108 ver. 1.1) and no change having impact on the quality on the Drug product should be implemented prior to approval from this directorate. Accordingly all are advised to submit updated PPO as per Document no, PPO/71108 ver 1.1 of Guidance for Industry including Appendix section (hard and soft copy) to this directorate within 15 days of issuance of this notice. (Dr. G. . Singh) Drugs Contro er General (I) To All Manufacturers/Importers of Vaccines