Is it required to inform all Market complaints and AEFI(Vaccines) to Regulatory Authorities ? If not what needs to be informed?
Please suggest.
There are different complaints.
Is it a minor complaint or major complaint.
You must review your SOPS take a formal approval from your QA and then analayse the whole process by CAPA methodology and incorporate the Risk evaluation process.
If its minor as per your system specification CAP them down.
If its a major compalint like you have failed in Sterility, Endotoxin , missing of one or more antigens in a Multivalent vaccines, Leachates found, Discolouration, Potency loss or Particulates in vaccine probably you have to recall that batch and intimate your regulatory athourities as immediately as possible and tell them about all your CAPA measures.
Depending the seriousness you have to take actions and your Quality assurance group, Compliance group and Regulatory departments will inform to concern authorities.
[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,
b)customer feedback,
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]
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?
Pl. suggest
[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,
b)customer feedback,
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]
Technically Vaccines are Small volume parenterals. They either come in small sized ampoules or 5ml or 10ml single or Multiple dosages.
Any particulate matter that is out of specification or out of identifiable substances is not at all acceptable. Black particles in parenterals/Vaccines are not acceptable. They must be rejected at the step of Visual inspection. If they pass in a large numbers out into market and once they are found, all the batch need to be called.
This is a Major regulatory breach and this is critical in issue and one has to intimate to concerned regulators immediately and give them what batches are recalled, recalled procedure, how you handled recalled batchs (you have nothing like reprocessing here–JUST DESTROY), what are steps taken to prevent such events occuring, did the company recieved similar complaints in other batches and how company handling that if they have.
Every Drug or Pharmaceutical or Biological or Immunology product will and shall have some observed reactions or side effects or contraindications on patients who take these products. These indications will be well studied and observed over and during clinical trials and will be well documented by experts from the manufacturing industry and the Doctors shall be notified prior to release of these products into markets. There will be a leaf let supplied by vaccine manufacturers which tells a bit or in detail about such reactions. " If there are new reactions which are new and which were not observed and recorded during preclinical investigations then the manufacturer should immediately RECALL the product and Notify the regulators".
In a way “NO NEW REACTIONS SHOULD BE OBSERVED WHEN A PATIENT IS ADMININSTERED A STANDARD OR SPECIFIED DOSE OR A KNOWN QUANTITY OF IMMUNOLOGICAL IN PRESENCE OF A PROPER MEDICAL GUIDANCE”.
Thanks for your guidance