Quality Working Party (QWP)
Adopted Guidelines
MP/QWP/1529/04 Guideline on Control of Impurities of Pharmacopoeial Substances
CPMP/QWP/609/96 Rev. 2
Note for guidance on Declaration of Storage Conditions for Medicinal Products
Particulars and Active Substances (Annex to note for Guidance on Stability Testing
of New Active Substances and Medicinal Products, Annex to Note for Guidance on
Stability of Existing Active Substances and Related Finished Products) (Adoption
by CPMP December 2003) Temporarily withdrawn http://www.emea.eu.int/pdfs/human/qwp/330901en.pdf
CPMP/QWP/130/96 Rev. 1
Note for guidance on Chemistry of the New Active Substance. (CPMP adopted December
2003)
CPMP/QWP/122/02 Rev.1
Note for guidance on Stability Testing of Existing Active Substances and Related
Finished products (Adoption by CPMP December 2003) http://www.emea.eu.int/pdfs/human/qwp/015801en.pdf
CPMP/QWP/609/96 Rev. 1
Note for guidance on Declaration of Storage Conditions for Medicinal Products
Particulars and Active Substances (Annex to note for Guidance on Stability Testing
of New Active Substances and Medicinal Products, Annex to Note for Guidance on
Stability of Existing Active Substances and Related Finished Products) (Adoption
by CPMP April 2003)
CPMP/QWP/3309/01 (EMEA/CVMP/961/01)
Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical
Industry and the Data to be forwarded in the Part II of the Dossier for a Marketing
Authorisation (Adopted by CPMP/CVMP February 2003)
CPMP/QWP/130/96 Note for guidance
on Chemistry of the New Active Substance. (CPMP adopted February 2003)
CPMP/QWP/158/01 Revision
(CVMP/115/01) Note For Guidance on Quality of Water for Pharmaceutical Use (Revision
adopted by CPMP/CVMP May 02)
CPMP/QWP/2845/00 Note for Guidance
on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose
Inhalation Products (CPMP adopted March 02)
CPMP/QWP/1719/00 Note for Guidance
on Medicinal Gases: Pharmaceutical Documentation (CPMP adopted Jan. 02)
CPMP/QWP/2820/00 (EMEA/CVMP/815/00)
Note for Guidance on Specifications: Test procedures and Acceptance Criteria for
Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products (CPMP/CVMP
adopted July 01)
CPMP/QWP/2819/00 (EMEA/CVMP/814/00)
Note for Guidance on Quality of Herbal Medicinal Products (CPMP/CVMP adopted July
01)
CPMP/EWP/QWP/1401/98 Note For
Guidance on the Investigation of Bioavailability and Bioequivalence (Adopted July
2001)
CPMP/QWP/072/96 CPMP/CVMP Note
for Guidance on Start of Shelf -Life of the Finished Dosage Form (Annex to the
NFG on the Manufacture of the Finished Dosage Form) (Adopted by CPMP/CVMP May
2001)
CPMP/QWP/159/01 (CVMP/271/01)
Note For Guidance onLimitations to the Use of Ethylene Oxide in the Manufacture
of Medicinal Products (CPMP/CVMP Adopted Mar. 01)
CPMP/QWP/848/96 (EMEA/CVMP/598/99)
Note for Guidance on Process Validation (CPMP/CVMP Adopted Feb. 01)
CPMP/QWP/3015/99 Note for Guidance
on Parametric Release (CPMP Adopted Feb. 01)
CPMP/QWP/2934/99 Note for guidance
for In-Use Stability Testing of Human Medicinal Products - Annex to Note for Guidance
on Stability Testing of Existing Active Substances and related Finished Products
and Note for Guidance on Stability Testing of New Drug Substances and Products
(CPMP Adopted Feb. 01)
CPMP/QWP/604/96 Note For Guidance
on Quality of Modified Release Products:A.Oral Dosage Forms; B. and Transdermal
Dosage Forms; Section I (Quality).
CPMP/QWP/8567/99 Explanatory
Note on the Operation of Two-Year Transition Period for Application of Note for
Guidance on Residual Solvents to Marketed Products
CPMP/QWP/054/98 Annex to Note
for guidance on Development Pharmaceutics (CPMP/QWP/155/96): Decision Trees for
Selection of Sterilisation Methods.
CPMP/QWP/115/95 Note for Guidance
on Inclusion of Antioxidants and Antimicrobial Preservatives in Medicinal Products
CPMP/QWP/158/96 Note for guidance
on Dry Powder Inhalers.
CPMP/QWP/576/96 Note for Guidance
on Stability Testing for a Type II Variation to a Marketing Authorisation(CPMP
adopted Apr.98).
CPMP/QWP/556/96 Note for Guidance
on Stability Testing of existing Active Substances and Related Finished Products.(CPMP
adopted Apr.98)
CPMP/QWP/155/96 Note for guidance
on development pharmaceutics (CPMP adopted Jan. 98).
CPMP/QWP/609/96 Note for guidance
on Declaration of Storage Conditions for Medicinal Products Particulars and Active
Substances (Annex to note for Guidance on Stability Testing of New Active Substances
and Medicinal Products, Annex to Note for Guidance on Stability of Existing Active
Substances and Related Finished Products) (CPMP Adopted, Jan. 98)
CPMP/QWP/159/96 Note for guidance
on Maximum Shelf-Life for Sterile Products after First Opening or following Reconstitution
(CPMP adopted Jan. 98).
CPMP/QWP/486/95 Note for Guidance
on Manufacture of the Finished Dosage Form(CPMP adopted Sept. 95).