Agreement will facilitate global market access for suppliers and their customers in greater China region
EXCiPACT, an organisation that provides independent third party certification of manufacturers, suppliers and distributors of pharmaceutical excipients worldwide, has agreed that Bureau Veritas Certification Hong Kong can undertake certification of the manufacture and distribution of pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) Certification Standards.
The agreement will benefit both parties by facilitating global market access for pharmaceutical excipient suppliers and their customers in the greater China region, the organisation said.
Auditors employed by Bureau Veritas Certification Hong Kong who have completed the formal EXCiPACT Training/Examination and have undertaken a witnessed audit of a pharmaceutical excipient supplier will become Certified Auditors under the EXCiPACT Certification Scheme and will be listed on www.excipact.org.
EU and US pharmaceutical excipient regulations now require drug manufacturers to carry out either their own or third party audits of all their starting material suppliers to demonstrate GMP and/or GDP compliance. The audit burden is huge.
Using GMP and GDP standards designed for excipients, the EXCiPACT Certification Scheme is already helping excipient users and suppliers to reduce this burden, save costs and ensure quality.
EXCiPACT says more certifying bodies and auditors are expected to be registered to the scheme in the near future.