United States Pharmaceopeia (USP) is planning to launch a pharma ingredients verification and qualification programme in India by November 2006. The programme will include verification of drug substances and exipients besides others, according to Dr Srini Srinivasan, a senior official at USP.
As part of the programme, USP will audit manufacturing site, review chemistry manufacturing and control documentation, test samples for compliance with USP, re-test and re-evaluate items periodically.
John T Fowler, chief business officer, USP said, the verification and qualification programmes offered by USP are even useful to small and medium companies and also those companies that are actively pursuing contract manufacturing. The companies that have undergone verification and qualification will undoubtedly have an edge over those companies that haven't.
USP's presence in India may help to offer valuable services to pharma companies in the Asian region in the coming years. On suitability, USP may offer similar programmes for pharma industry in China, Fowler added.
Senior officials at USP informed, an advisory group has been set up constituting USFDA, International Exipient Council and other expert organisations to frame and offer the programme. The programme will enable pharmaceutical companies to face audits and regulatory inspections more effectively. USP will also give its mark and certificate after the programme to the companies.
The USP verification programme will benefit regulatory bodies, manufacturers of APIs and dosage forms. In its efforts towards harmonisation, USP is also holding discussions with EDQM for mutual recognition.
Dr Srini said, the duration for carrying out an ingredient verification programme may vary from case to case, as of now USP's dietary supplements verification programme is completed within three months to three years, depending on each case.
USP is keen to offer consulting, training and certification services to the Indian pharma industry. USP has recently set up its Indian office at Hyderabad, which also has a distinction of the only USP office outside the US. The establishment of USP-India is in line with USP's global public health strategy and its primary mission to promote public health by disseminating authoritative standards and information for medicines, other health care technologies, and related practices used to maintain and improve health and promote optimal health care delivery.
Located in the ICICI Knowledge Park in Hyderabad, USP India will provide its broad range of pharmacopoeial services to USP customers in India and the neighbouring countries. The site includes a state-of-the-art laboratory and involves experienced Indian scientists in the standards-setting activities of USP.