USP trains NAFDAC inspectors, manufacturers
It was a beehive of activities at the five-day training held for inspectorate officials of the National Agency for Food and Drug Administration and Control (NAFDAC), local pharma manufacturers and industrial pharmacists.
Themed ‘Advanced Good Manufacturing Practices Training,’ the conference, which was organised by the United States Pharmacopeia (USP) from 14 to 18 March at Banex Hotel in Anthony, Lagos, was aimed at promoting quality of medicines in Nigeria.
In his presentation, Teferi Bedane, a senior GMP specialist, highlighted several issues associated with pharmaceutical manufacturing, including product quality monitoring, corrective action and preventive action (CAPA), change management system, out of specification (OOS) handling and root cause analysis.
Bedane noted that Good Manufacturing Practice (GMP) must be applied throughout products’ life-cycle, while arguing that the desired established character of a product in terms of identity, strength and purity must be defined.
The Ethiopian expert canvassed accuracy and promptness during the entire manufacturing process with the aid of CAPA.
“As I mentioned earlier, CAPA can be described as an absolute measure that defines the backbone of pharmaceutical quality system. And, of course, only someone who is part of the company’s quality assurance team has the power to approve a change to meet up with the standard of procedure (SOP),” he said.
In his summation, retesting or resampling is necessary only when out of specification investigation reveals equipment malfunction or sample handling error (dilution error).
“When this happens, the sample used for retesting should be taken from the same samples. Secondly, the retesting can only be performed by an analyst other than the one who performed the original test result,” he stressed.
Discussing the role of USP in Nigeria pharmaceutical industry, Dr Chimezie Anyakora, a consultant and USP chief of party explained that the United States’ organisation is an independent, non-profit scientific organisation that sets quality standards for medicines in the United States (US) that are enforceable by the U.S. Food and Drug Administration.
Anyakora also disclosed that USP and the United States Agency for International Development (USAID) formed a cooperative agreement about 20 years ago to promote the quality of medicines globally.
“This gave rise to a USP programme known as ‘Promoting the Quality of Medicines (PQM)’. Today, PQM is active in 38 countries,” he said.
He added that the PQM programme has been active in Nigeria for about four years, with its office being formally established last year in Lagos.
Dr Anyakora is presently the chief of party for the PQM initiative in Nigeria.