Complaints And Recalls Handling In API Manufacturing Unit- Pharma

COMPLAINTS AND RECALLS
All quality related complaints, whether received orally or in writing, should be recorded and investigated according to a written procedure.
Complaint records should include:
− Name and address of complainant;
− Name (and, where appropriate, title) and phone number of person submitting the complaint;
− Complaint nature (including name and batch number of the API);
− Date complaint is received;
− Action initially taken (including dates and identity of person taking the action);
− Any follow-up action taken;
− Response provided to the originator of complaint (including date response sent); and
− Final decision on intermediate or API batch or lot.
Records of complaints should be retained in order to evaluate trends, product-related frequencies, and severity with a view to taking additional, and if appropriate, immediate corrective action.
There should be a written procedure that defines the circumstances under which a recall of an intermediate or API should be considered.
The recall procedure should designate who should be involved in evaluating the information, how a recall should be initiated, who should be informed about the recall, and how the recalled material should be treated.
In the event of a serious or potentially life-threatening situation, local, national, and/or international authorities should be informed and their advice sought.

Reference:- ICH HARMONISED TRIPARTITE GUIDELINE
GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS Q7

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