Q11 Development and Manufacture of Drug Substances Q&A (regarding the selection and justification of starting materials)

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. 

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Final Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products

This guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products that FDA issued on January 22, 2013 (final rule).2 (21 Code of Federal Regulations (CFR) part 4). Prior to issuance of the final rule, although CGMP regulations were in place to establish requirements for drugs, devices, biological products, and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), there were no regulations to clarify and explain the application of these CGMP requirements to combination products. The final rule did not establish any new requirements; it was intended to clarify which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products, and to set forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with applicable CGMP requirements.

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Guideline on process validation for finished products - information and data to be provided in regulatory submissions

This guideline replaces the previous note for guidance on process validation (CPMP/QWP/848/96, EMEA/CVMP/598/99). The guideline is brought into line with ICH Q8, Q9 and Q10 documents and the possibility to use continuous process verification in addition to, or instead of, traditional process validation described in the previous guideline has been added and is encouraged. This guideline does not introduce new requirements on medicinal products already authorised and on the market, but clarifies how companies can take advantage of the new possibilities given when applying enhanced process understanding coupled with risk management tools under an efficient quality system as described by ICH Q8, Q9 and Q10.

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EDQM Management of Documents and Records

Management of documents and records is one of the pillars of a quality management system (QMS).

Several chapters of the ISO/IEC 17025 4.2 Management system, 4.3 Document control, 4.13 Control of records and 5.4.7 Control of data are dedicated to these topics.

This document replaces Guideline PA/PH/OMCL (97) 5 and the part of Guideline PA/PH/OMCL (07) 105 DEF related to the archiving of records.

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Q11 Implementation Working Group Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers

Since the ICH Q11 guideline was finalised, worldwide experience with implementation of the recommendations on the development and manufacture of drug substances has given rise to requests for clarification relating to the selection and justification of starting materials. This Question and Answer (Q&A) document is intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials and on the information that should be provided in marketing authorisation applications and/or Master Files. The focus of the Q&A document is on chemical entity drug substances.

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