News about GMP/cGMP

Here is the list of responses:

• AEGSP - Association of the European Self Medication Industry
• APIC - Active Pharmaceutical Ingredients Committee
• AstraZaneca
• EDQM - European Directorate for the Quality of Medicines and Healthcare
• EFPIA - European Federation of Pharmaceutical Industries and Associations
• IFAH Europe - International Federation for Animal Health Europe
• NL Health Care Inspectorate
• Prateek Goyal
• PDA - Parenteral Drug Association
• Teva Pharmaceutical Industries
• TGA - Therapeutic Goods Administration
• Vertex

It is well worth taking a closer look at the detailed comments and proposed modifications. Various points of criticism are targeted, ranging from the required RTRT Master Plan up to the use of new terminology in vague wording. Taking part in public consultations is an important possibility to narrow down the gap between legal requirements and the possible practical implementation and application of the regulation.

Source:

EC: Good Manufacturing Practices – Major Developments