Monday, June 17, 2013

Pharmaceutical Complaint, Recall, Corrective Action, Preventive Action, In-Process Control, Sanitation, Houskeeping & Self-inspection

1.      Define complaint & recall.
All quality related complaints of a product from the market should be recorded & investigated accordingly to a written procedure.

Recall is the removal from the market of specified batches or all batches of a product. A recall situation can result from information entering a company in various ways:
                           Customer complaints – these may be so serious as to initiate a     
                recall.  An example could be the evidence of a lack of sterility
                           GMP deviations/results of a failure investigation 
                           The result from the QC stability programme
                           Request by the regulatory authorities
                           Result of an inspection
                           Known counterfeiting or tampering
                           Adverse drug reaction (ADR) reported, leading to a recall decision (however, an ADR does not automatically lead to a recall).

2.      Define Corrective Action & Preventive Action ?

Preventive Action : In order to prevent occurrence the potential action has to be taken from non         conformity, defect or other undesirable situation.

Corrective Action :  Action has to be taken to eliminate the detected non conformity or other undesirable situation.

3.      What is In Process Control  ? Why it is important ? 
To ensure the product conformation of its specification, checking & monitoring are performed during production. The controlled of the environment or equipment may also be regarded as part of in process controlled.

Importance : It is important to adjust the process to assure that the product confirms to it final specification.

4.      What is Sanitation & House keeping?

Sanitation : It is the hygienic control on manufacturing process including personnel, premises, equipment & material handling.
Housekeeping is the practice of keeping the workplace clean, tidy & free of potential hazards. Correct housekeeping is practised before, during & after the task is completed.

5.      What is self inspection?

Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.

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