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RAPS: New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India

23.03.2017
The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis ...

GMP: EMA issues new Guideline on "Chemistry of Active Substances"

05.01.2017
A medicinal product authorization application requires comprehensive information on origin and quality of an active substance. What information is required was defined in two Guidelines so far: ...

RAPS: WHO Seeks API Manufacturers for Prequalification Program

25.10.2016
The World Health Organization (WHO) has released an invitation to active pharmaceutical ingredient (API) manufacturers as part of an effort to increase access to and the affordability of care and ...

RAPS: EU, Japan to Share More Information on GMP Inspections

25.10.2016
The European Directorate for the Quality of Medicines and Healthcare (EDQM) this week announced a new agreement with Japanese authorities to share more information on the outcome of good ...

FDA: Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

20.10.2016
This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing ...

GMP: Effect of primary packaging on drug stability of solid dosage forms

08.09.2016
A stimuli article on The Effect of Primary Packaging on the Physical Degradation of Metformin, Lisinopril, and Simvastatin Solid Doses During Patient Use When Stored at Different Temperature and ...

GMP: EMA\'s new Draft Guideline on the Sterilisation of Medicinal Products, APIs, Excipients and Primary Containers

09.06.2016
As referred to in the European Pharmacopoeia, the procedure for terminal sterilisation of a medicinal product, an API, or an excipient is generally the method of choice. Yet, this might be ...

EMA: Current European Non-Compliance Report for an Indian API Manufacturer

09.06.2016
Major deficiencies observed during GMP inspections are entered into the EudraGMDP database. There, you can find a current Non-Compliance Report issued by the Italian Medicines Agency for the ...

GMP: EMA\'s new Draft Guideline on the Sterilisation of Medicinal Products, APIs, Excipients and Primary Containers

11.05.2016
As referred to in the European Pharmacopoeia, the procedure for terminal sterilisation of a medicinal product, an API, or an excipient is generally the method of choice. Yet, this might be ...

GMP: EMA publishes finalised Process Validation Guideline for Biotech Products

11.05.2016
Approximately two years ago the EMA published a draft guideline on process validation for the manufacture of biotech products. Now the final guideline has been published under the title ...