Guidance for Industry: Preparation

Guidance for Industry Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (draft guidance) (July 2007)... 

FDA. (2002), Guidance for Industry. Preparation of Food Contact Notifications for Food Contact Substances Toxicology Recommendations. Final Guidance. 4/2002. Accessed online at http //www.cfsan.fda.gov/ dms/opa2pmnt.html... 

US Food and Drug Administration, Centre for Food Safety and Applied Nutrition, Office of Premarket Approval, May 2002, Guidance for Industry, Preparation of Premarket Notifications for Food Contact Substances Chemistry Recomendations, 1999. 

Section 11 D (C) Food Simulents, Appendix 11, Selected Migration Testing Protocols Guidance for Industry Preparation of Pre-Market Notification for Food Contact Substances Chemistry Recommendations, April 2002. 

The Food and Drug Administration (FDA) also accept submissions prepared according to the CTD format. However, they have not directly incorporated the CTD format into US regulatory requirements, which are detailed in Title 21 CFR, Part 514.50 in the case of a New Drug Application (NDA), or Title 21 CFR Part 601.2 (a) in the case of a Biologies License Application (BLA). Rather, they have introduced the CTD format via Guidance for Industry documents. The correlation between the requirements in 21 CFR Part 514.50 and the CTD format is shown in Table 6.2. 

This procedure provides the information required to support the sterility assurance of the drug product (product name), USP, manufactured by ABC Pharmaceutical Industries. It references the FDA Guidance titled Guidance for Industry for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Dmg Products prepared by the Sterility Technical Committee of the Chemistry Manufacturing Controls Coordinating Committee of the Center for Dmg Evaluation and Research (CDER) and the Center for Veterinary Medicine (CVM) in November of 1994. 

Postmarketing Reporting of Adverse Drug Experiences, March 1,1992. Center for Drug Evaluation and Research (CDER). Guidance for Industry. Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review, Nov. 1,1992. 

FDA Draft Guidance for Industry, Nonclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (in preparation). 

FDA Guidance for Industry Guideline for the Preparation of Investigational New Drug Products (Human andAnimal),March 991. Accessed January 1, 2006, at http //www.fda.gov/cder/guidance/old042fn.pdf. 

Guidance is available to assist manufacturers in preparing the quality system information required in the PMA application. This is particularly valuable for companies who elect a modular review. If the company elects to use this method, the FDA suggests that the design control information and manufacturing information be submitted in modules that are separate from other information. (See Quality System Information for Certain Premarket Application Reviews Guidance for Industry and FDA Staff, issued February 3, 2003.)... 

An example of what can happen with raw materials that are insufficiently controlled by foreign authorities occurred in China with heparin. The raw material was intentionally adulterated with over-sulfated chondroi-tin sulfate (OSCS). Heparin injections prepared from this raw material in the United States have led to severe hypersensitivity reactions in patients [8]. The Ph. Eur. monograph has been revised with a test to detect this impurity, on recommendation of the EMA/CHMP assessment report about this topic [9]. In June 2013 the FDA issued a Note for Guidance for Industry about this subject to manufacturers taking steps to ensure that the heparin supply chain is not contaminated with OSCS [10]. 

This document has been prepared in response to the many requests from industry for guidance in the preparation of petitions for submission to the Center for Food... 

We discussed in Section 7.8 the tripartite harmonization of common technical documents (CTDs) by the US, Europe and Japan. The GMP Guidance is one of these CTDs it is described in the ICH Q7A document called GMP Guidance for Active Pharmaceutical Ingredients. Because of the wide implications of this guide, the Steering Committee of ICH invited experts from Australia, India and China and industrial representatives from the generics industry, self-medication industry and PIC/S (Pharmaceutical Inspection Cooperation Scheme, Section 7.10) to participate in Jihe preparation of this document. Hence, the Q7A document has been endorsed as a truly international document for GMP. 

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