Thanks for your suggestions.Also please let me know ,Is there any specific Regulatory Guidance on what type of complaints needs to be informed?
For ex. a small Black particle in a vial, less volume…etc.is such incidents needs to be informed to Regulatory persons?
If pain, swelling, observed at the site of Injection after vaccination…what should be the course of action?
[quote=DURGA PRASAD][COLOR=“black”]The organization shall determine and provide the resources needed
[b]a) to implement (and maintain) the quality management system and maintain (continually improve) its effectiveness, and
b) to meet regulatory and (enhance customer satisfaction by meeting) customer requirements.[/b]
The input to management review shall include information on
a)results of audits,
c)process performance and product conformity,
d)status of preventive and corrective actions,
e)follow-up actions from previous management reviews,
f)changes that could affect the quality management system, and
g)recommendations for improvement, and new or revised Regulatory Guidances
h) Complaint register, Market complaint handling, Product recall procedures and Risk based actions.[/color][/quote]