Handling market complaint Product Recalls

How to handle market complaint, and handling of Product Recalls. Regulatory requirements for pharmaceuticals

We are providing our readers with a guidelines about how to handle market complaint, and handling of Product Recalls , you too can contribute by comment which will be published over here.

Handling of market complaints.

There should be a written procedures or a standard operating procedure (sop ) made for handling of every complaint must be carefully

The Pharmaceutical manufacturing company should assigne accountability for handling of complaints to a senior and responsible person and there should be adequate qualified team of peoples available to assist him. He should be aware of all complaints, investigation, or recalls, a person from quality control team should be a part of an investigation of any complaint.

If there is a defect in product detail procedures recorded reciting the action to be taken, along with the reasons why the products is recalled.

Investigational findings must be properly recorded with all original details

If there is a defect is or suspected in a batch, priority should be given to ascertain that the defect is not there in other batches, and other batches too should be checked to assure that they are not affected.

The batches which are manufactured by addition of recovery of the defective batch should be investigated.

If required adequate actions, including product recall, should be taken after investigation , analysis and assessment of the complaint.

The respective batch records, the corrective measures taken against the complaint should be recorded, including the recalls if applied.

Complaints records must be periodically reviewed and studied to see if there is constant reoccurrence of a particular type of defect or problem up on which recall of products could be justified.

The concerned regulatory authorities are must be informed if a pharmaceutical manufacturer finds the defect possibly due to manufacturing process, degradation, or any other reason.

Product recall procedure

Recall operations must be initiated effectively up to the level of hospital or pharmacy or a drug store.

All regulatory authorities of all countries where the defective product is distributed must be to appropriately informed about the purpose of recall and the product to be recalled

The record of distribution of product must be properly maintained for direct customers sale or export or samples for physicians or doctors and must be made available without any delay, with the details of persons responsible for distribution activity.

The process of recall of defective products must be documented every day and must be updated with the all recalls and pending recalls and a final reconciliation report should be submitted, which should justify any difference in quantities distributed and recalled.

The efficacy and effectiveness of recall procedure should be evaluated periodically.

Pharmaceutical companies should decide and record all final actions taken on all recalled goods, it should also take care of all stored goods with proper instruction until the final action is not taken on the recalled goods.

=======================================================================
What is What is 510(k) Clearances ?
What is 510(k) Clearances, Premarket Notification for medical devices – PMN or 510(k)

Antibiotic Definition and classification

Antibiotic resistance and Drug resistance mechanism

Antioxidants food supplements

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D

What is an antibody? what is monoclonal and polyclonal antibodies?

Enzyme linked immunosorbent assay ELISA

Raido Immuno assay
http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definations.

http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing

Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coeeficient of a disinfectant

Sterility testing

Clean Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controlling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation