If the VMP and SMF were reviewed annually, how about the frequency of review for Quality System Manual? Is it also annually?
Management review should provide assurance that process performance and product quality are managed over the lifecycle. Depending on the size and complexity of the company, management review can be a series of reviews at various levels of management and should include a timely and effective communication and escalation process to raise appropriate quality issues to senior levels of management for review.
The above text is copied from Pharmaceutical Quality System (ICH Q10) that was published by EMEA on 31st Januray 2011.
This explains that Quality Management system or Pharmaceutical Quality System should be reviewed continually on a time basis.
The effective review will be 6 months.
The reasons might be
-Regulatory Updates
-ISO updates
-If you are a CMO-- Updates from your Client
-Regulatory inspection findings
-CAPA and RCA findings from Internal or external audit sources.
-BMR/BPR and QC record reviews.
-Document management and Risk based Validation findings.
-New projects and Novel Drugs or Clinical products from R&D.
-Continuous improvement polocy (KAIZEN)
-Lean implementation
etc etc
Thank you Sir. Your brief but concise explanation is highly appreciated.