Brazil delays excipient GMP deadline
pharmafile | September 6, 2012 | News story | Manufacturing and Production |Â Â ANVISA, Brazil, GMPÂ
Brazil’s national medicines regulatory agency ANVISA has delayed proposed new rules on good manufacturing practice (GMP) for pharmaceutical excipients after a series of strikes by government staff.
ANVISA published a draft resolution earlier this year which aims to introduced GMP for excipients used in medicines used in Brazil, including the introduction of a licensing scheme for excipient suppliers and formal requirements for manufacturing facility inspections.
The document – first published at the end of May – was due for a 60-day comment period which ended on August 2. An English version has been provided by pharma trade group Rx-360 and is available here.
However, since the agency has been affected by a widespread strike of government officials in July and August – which resulted in two thirds of ANVISA staff being off work – an additional 60-day period has been agreed. The striking workers were schedule to return to their jobs on September 3.
The proposed GMP rules lay out standard operating procedures which must be applied by the manufacturer “to ensure that used facilities, methods, processes, systems, and controls are proper to ensure the quality of the pharmaceutical excipient”.
The draft states that while the resolution will take effect on the date of its publication, existing establishments will have 12 months to come into compliance. New facilities must comply immediately.
The International Pharmaceutical Excipients Council (IPEC) Federation has been in discussion with ANVISA regarding the proposals and said that while the requirements are a little more stringent than its own GMP standards, the agency appears open to negotiation.
Brazil’s overtures in this area come shortly after China published its own GMP regulations for pharmaceutical excipients – which were finalised within weeks and are due to come into force in February 2013 – and also new rules governing excipients that are included in the EU’s falsified medicines directive.
The initiatives come amid growing recognition of the critical role that excipients play in medicines and the potentially catastrophic consequences that can follow if supply is compromised by quality problems or even deliberate adulteration.
Just this week, concerns have surfaced about the use of ‘gutter oil’ – reclaimed from kitchen waste – in the manufacture of antibiotic products in China.
Earlier this year, the country was also rocked by a major scandal involving chromium contamination of gelatin-based capsules, while there have been a string of incidents in the past years in which contamination of glycerin caused fatalities in countries such as Haiti, Panama and Nigeria.
Recognising that a harmonised set of standards for excipient manufacture and distribution would help secure supply chains, IPEC has set up an excipient certification scheme – called EXCiPACT – to make it easier for drugmakers to identify reliable, quality suppliers via a third-party accreditation system.
Phil Taylor
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