RESOURCES
Organizations
Food and Drug Administration (FDA)
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. Find out more at: https://www.fda.gov
American Association of Pharmaceutical Scientists (AAPS)
Founded in 1986, the AAPS is a professional, scientific organization of approximately 7,000 individual members and over 10,000 actively participating stakeholders employed in academia, industry, government, and other pharmaceutical science related research institutes worldwide.
https://www.aaps.org
California Sharing Science Solutions (CASSS)
CASSS is an agile, non-profit scientific community whose strength is bringing together professionals from industry, academia, and regulatory agencies to solve scientific and technical problems to advance the field of biopharmaceutical development.
https://www.casss.org
Parenteral Drug Association (PDA)
The PDA is the leading global facilitator of science, technology and regulatory information. The organization provides technical documents, training and conferences for professionals to discuss currents issues and trends.
https://www.pda.org
BioProcess International (BPI)
Bioprocess International is a monthly, controlled-circulation publication devoted to the development, scale-up, and manufacturing of biotherapeutics and biodiagnostics. BPI organizes yearly biprocessing conferences focusing on the science and technology of biologics. https://lifesciences.knect365.com/bioprocessinternational
Documentation
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Q1A(R2): Stability Testing of New Drug Substances and Products
This Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for Climatic Zone I and II. Furthermore, the revised document takes into account the requirements for stability testing in Climatic Zones III and IV in order to minimise the different storage conditions for submission of a global dossier.
Q2(R2): Analytical Validation Guideline for Residual Solvents
The scope of the revision of ICH Q2(R1) includes validation principles that cover analytical use of spectroscopic or spectrometry data (e.g., NIR, Raman, NMR or MS) some of which often require multivariate statistical analyses.
Q3A(R2): Impurities in New Drug Substances
The Guideline addresses the chemistry and safety aspects of impurities, including the listing of impurities in specifications and defines the thresholds for reporting, identification and qualification.
Q3E: Extractables and Leachables
The Guideline was established to work on the development of the Q3E Guideline on the assessment and control of extractables and leachables (E&L), and is expected would assist both applicants and regulators by providing focus on critical aspects, and improving transparency in requirements for medicinal products including drug delivery device components.
Q5C: Quality of Biotechnological Products -- stability testing of biotechnological/biological products
This document augments the stability Guideline (Q1A) and deals with the particular aspects of stability test procedures needed to take account of the special characteristics of products in which the active components are typically proteins and/or polypeptides.
Q5E: Comparability of Biotechnological/Biological Products subject to changes in their Manufacturing Process
The objective of this document is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product. Therefore, this Guideline is intended to assist in the collection of relevant technical information which serves as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety and efficacy of the drug product.