Regulatory information

FDA
US Food and Drug Administration
NEW draft guideline:
  Analytical Procedures and Methods Validation
  Now includes methodologies to particle size
  analysis.
NEW and IMPORTANT guideline:
  Part 11 - Scope and Application
  FDA's current thinking of electronic records
  includes a re-examination of Part 11 and a
  withdrawal of the previous draft guidance.

ICH
International Conference on Harmonisation
IMPORTANT guideline:
  Q6A Specifications: Test Procedures and
  Acceptance Criteria for New Drug Substances
  and New Drug Products:
  Chemical Substances.
IMPORTANT Decision Trees:
  Decision Tree #3 : Setting Acceptance
  Criteria for Drug Substance PARTICLE SIZE
  DISTRIBUTION.

IFPMA
International Federation of Pharmaceutical Manufacturers Associations

EMEA
The European Agency for the Evaluation of Medicinal Products

EUDRA
This portal is a EudraNet service to the European Pharmaceutical Regulatory Sector

Method standards

DS
Dansk Standard
(Danish Standards Association)

ISO
International Organization for Standardization

Particle standards

Duke
Duke Scientific Corporation

NIST
National Institute of Standards and Technology

Contract research organizations

Galenica
Consultancy services in the field of galenical pharmacy.

Equipment manufacturers

Malvern Instruments
Leading manufacturer of equipment for particle size analysis.