Tuesday, 17 November 2015

WHO Inspection Findings – NOC (Notice of concern)

WHO Inspection Findings –
 NOC (Notice of concern)

The WHO prequalification team plans and coordinates the performance of inspections (announced or unannounced) of the site(s) of manufacture of selected Active Pharmaceutical Ingredients API(s), the Finished Pharmaceutical Product (FPP), and of selected clinical testing units or Contract Research Organization (CRO). The inspection report listing all the observations and findings is prepared after the inspection (WHOPIR – WHO Public Inspection Report) and provided to the manufacturer or CRO as relevant. The manufacturer and or CRO has to take appropriate corrective and preventive action and submit a response to the inspection report for assessment by the inspectors.

NOC (Notice of concern) is a letter that is issued to a firm (i.e manufacturer, contract research organization or quality control laboratory), by the WHO Prequalification of Medicines Programme, if WHO has concerns regarding compliance of the site with specified standards such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) or Good Laboratory Practices (GLP). In other words an NOC contains the factual observations made during an inspection.
NOC was introduced in Jun 2008 by the WHO Prequalification of Medicines Programme.The WHO Notices of Concern are very similar to FDA Warning Letters.  Like FDA Warning Letters, NOC  is also published on the internet.

An NOC states observations made during an inspection that are considered to be "critical" or "major" non-compliances with WHO norms and standards, that are of concern in relation to quality management or quality assurance; or "critical" or "major" non-compliances with WHO norms and standards that were not satisfactorily addressed in the response from the company to an inspection. 
If there are immediate public health concerns or if the inspection observations relate to misrepresentation of data, falsification or manipulation of data with the intent to deceive, the NOC will be immediately published on the Prequalification of Medicines Programme web site. In other cases the NOC will be published after the corrective actions described in the response to the observations noted in the NOC have been reviewed and the review determines that the corrective actions are unsatisfactory (which may include not providing suitable objective evidence of corrective actions, if applicable).  It may also be published if a response to the observations noted in the NOC is not received within 30 days from the date of the NOC, as requested. In addition, an NOC may be issued if a manufacturer refuses inspection of their manufacturing site.

An NOC will remain active on the WHO Prequalification of Medicines Programme web site until WHO is satisfied with firms CAPA.
During the period that an NOC is in place the PQ Team Inspection Services will perform additional and more frequent inspections if the site is still supplying prequalified product. If the site has been suspended then the next inspection will be performed when the company advises that it considers that it has adequately dealt with the matters that led to the NOC. Following such follow up inspections and if satisfied that sufficient improvements have been made by the site, PQT Inspection Services will recommend the lifting of the NOC and that the site inspected may be named/continue to be named in the relevant dossiers under prequalification or already prequalified. If the NOC has been published on the website then the NOC is then removed from the website and placed in the archive.

WHO Enforcement Actions

If WHO identifies a public health risk, appropriate additional steps are taken to safeguard public health.  These steps may include:
  • Suspension of products on the "List of prequalified products"; (Notice of Suspension)
  • Recall of batches of products on the "List of prequalified products" that had been supplied by a manufacturer;
  • Rejection of applications submitted for assessment to the Prequalification Programme.

No comments:

Post a Comment