as of 2019 - 05 - 07

22.B Regulatory aspects and guidance documents

22.B Regulatory aspects and guidance documents
In this chapter you will find answers to the following questions:

What is the legal position with regard to GMP for excipients?

What standards of GMP apply to the manufacture of Pharmaceutical Excipients?

What kind of guidance is given by the IPEC-PQG GMP Guide?

What is the IPEC and which objectives and activities does it pursue?

Which guidance documents are published by IPEC?

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