Translation Uplift Program Resource Library

Translation 1: Product Development

Translation 2: Process Scale Up

Translation 4: Phase Appropriate GMPs

Translation 5: Managing Complex Supply Chains

Translation 6: Process Validation

A glossary of key terms and abbreviations

For Transient Transfection-Based Lentivirus Production in Suspension

This review assesses the state of the art in digital advances in scaling bioreactors and the advantages and limitations of scaling techniques. Traditional approaches and their constraints are outlined.

This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes.

This guidance provides recommendations to holders of applications for human drugs and biologics on implementing a chemistry, manufacturing, and controls (CMC) post-approval change through the use of a comparability protocol (CP).

This guidance provides recommendations to applicants on preparing and using comparability protocols for post-approval changes in chemistry, manufacturing, and controls (CMC).

ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Standards Organisation (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”.

These guiding principles on transfer of technology are intended to serve as a framework which can be applied in a flexible manner rather than as strict rigid guidance.

Since clinical trials can be designed as multi-centre studies potentially involving different Member States, it is the aim of this guideline to define harmonised requirements for the documentation to be submitted throughout the European Union.

This workshop focused on potential scientific and regulatory approaches to address challenges associated with expedited product development, so that robust quality and manufacturing data packages will be submitted to enable timely access to medicines for patients whilst assuring that product safety, efficacy, and quality will not be compromised.

This guidance describes an approach manufacturers may use to implement manufacturing controls that are appropriate for the phase 1 clinical trial stage of development.

The objective of this update is to bring the guideline in line with current expectations and trends in good practices and to harmonize the text with the principles of other related international guidelines.

The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product.

The manufacture of sterile products is subject to special requirements in order to minimise risks of microbiological contamination, and of particulate and pyrogen contamination.

This document provides guidance to persons who, in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA,3 have chosen to maintain the records or submit designated information electronically and, as a result, have become subject to part 11.

The Supply Chain Security Toolkit is a resource that addresses areas of vulnerability in the medical product supply chain.

The remote assessment process was introduced during the pandemic to provide atool for continuing to perform remote assessments where it has been difficult to travelto perform on-site inspections and/or to prioritise inspections.

This guidance describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements.

This document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture.

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.

These guidelines cover the general principles of qualification and validation.

This document covers process validation of biotechnology-derived proteins used as active substance in the manufacture of medicinal products. It addresses the data requirements for process validation for submission of a marketing authorisation application or variation.

This presentation explores the adoption of the updated Annex 1 of the PIC/S GMP Guidelines for sterile medicinal products, and provides a roadmap for manufacturers to help ensure compliance.

Translation Uplift Program Resource Library

Access a curated catalogue of useful and industry relevant resources

General Resources

Country Specific Guidelines

Preclinical Studies

Clinical Studies

Other Resources

Case Study Templates

Process Characterization

Considerations for Bioreactor Process Development and Scale-Up

Digitally enabled approaches for the scale up of mammalian cell bioreactors

Addressing Process Scale-up Concerns in Chemical and Pharmaceutical Manufacturing

Confidence when Scaling up

Addressing Bioprocessing Scale-Up Challenges

FDA Guidance for Industry: Process Validation General Principles and Practices

Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information

FDA Guidance for Industry: Comparability Protocols Chemistry, Manufacturing, and Controls Information

ICH Q10

WHO Guidelines on Transfer of Technology in Pharmaceutical Manufacturing

Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials

EMA–FDA Joint Q&As on Quality & GMP Aspects of PRIME/Breakthrough Therapy applications

Guidance for Industry CGMP for Phase I Investigational Drugs

WHO Good Manufacturing Practices for Investigational Products

ICH Q8 Pharmaceutical Development

ICH Q10

GMP For Medicinal Products - Annexes

Guidance for Industry Part 11, Electronic Records Electronic Signatures - Scope and Application

Roadmap for Supply Chain Security

PIC/S Guidelines - Remote Assessments

FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs Quality Agreements

PIC/S Validation Master Plan Installation & Operational Qualification Non-sterile Process Validation Cleaning Validation

EMA Guideline on Process Validation for Finished Products

WHO: Good Manufacturing Practices Guidelines on Validation

EMA: Process validation for the manufacture of biotechnology

TGA Presentation at GMP Forum: PIC/S Revision of Annex 1

Pages

Policy Pages

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