Guide for Pharmaceutical Manufacturing Industry Research & Development Medical Pharmacy Students FDA updates Guidelines
Custom Search
Showing posts with label How to handle market complaint ?. Show all posts
Showing posts with label How to handle market complaint ?. Show all posts

Friday, July 9, 2010

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

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Electronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates

Here is an intresting article on world wide pharmaceutical industry
Article on Pharmaceutical Industry pharmaceutical industry

Here are some interesting articles on Quality assurance systems for pharmaceutical company
1.Quality assurance in pharma industry
2.Quality by design concept for pharmaceutical industry
3.Quality by design concept in pharmaceutical industry an  explanation

Wednesday, September 3, 2008

Pharma GMP Training Questions and Answers Complaints Recalls

Test Paper 5 – WHO GMP Training

Section – Complaints and Recalls

WHO GMP Training Questions and Answers Section for pharmaceutical manufacturing units :- Complaints and Recalls
In this post i am giving some questions of which you may know answers or you may like to know answers ,i have given few options for you to think up on , this is a very good tool to gather knowlede these questions are provided with answers at the bottem of every page ,so enjoy solving them, you can use these questions and answer sheet to train your personnels.



1. The principle for complaints handling is that:

.(A) .Companies need review only complaints about defective products.

.(B) .A company must review all complaints and other information about potentially defective product.

.(C) .Only complaints from pharmacists are reviewed.

.(D) .A company may find written procedures useful.


2. A person for handling complaints:

.(A) .Must be designated in writing by every company, large or small.

.(B) .Does not have to inform the QC manager that he or she is investigating a complaint.

.(C) .Can be appointed by the company from time to time as a complaint is received.

.(D) .Must be able to handle all incoming complaints alone.


3. The written procedures sop:

.(A) .Only describe who takes what action about a defective product.

.(B) .Do not need to consider the need for a recall.

.(C) .Do not need to record the original details but just the findings.

.(D) .Are required to handle a complaint concerning a possible product defect.


4. Any complaint concerning a product defect:

.(A) .Doesn’t need to involve the quality control department.

.(B) .Only needs thorough investigation if it will result in a product recall.

.(C) .Should be recorded with all the original product details, and thoroughly investigated.

.(D) .Doesn’t need to have all the details recorded so long as the results are recorded.


5. If a product defect is discovered in one batch:

.(A) .A company must have given consideration as to whether other batches should be reviewed.

.(B) .The company must investigate batches containing reprocessed product from that batch.

.(C) .There is great relief that no other batches need investigating.

.(D) .The investigation can be terminated by the medical director in case other batches are found to be defective.




6. After investigating a complaint:

.(A) .There is a need for follow-up action to maintain product confidence.

.(B) .The company is allowed to relax because the Sales Manager will talk to the person who complained and smooth things over.

.(C) .The company can do everything except consider a product recall.

.(D) .The company must take all appropriate follow-up action including a possible product recall.


7. All decisions and measures taken:

.(A) .Are only recorded if there is a product recall.

.(B) .Are recorded but do not need to be cross-referenced to original batch records.

.(C) .Should be recorded and referenced to the corresponding batch records.

.(D) .Small manufacturers can be exempted from this requirement by the Minister.


8. Complaint records:


.(A) .Only need to be reviewed to see if they are complete before an inspector comes.

.(B) .Should be regularly reviewed for any specific problems.

.(C) .Are reviewed only to see whether a product recall might be required.

.(D) .Don’t need to be written in small companies.


9. As the competent authority, you have to be informed:

.(A) .Only if a recall is possibly needed.

.(B) .If there are serious quality problems with a product.

.(C) .Only if there is a storage defect.

.(D) .Only if there are differences between what is registered and what has been done.


10. The principle for product recall is:

.(A) .Is not the responsibility of the manufacturer once the product has left the factory.

.(B) .That there should be a system to recall from the market, promptly and effectively, products known or suspected to be defective.

.(C) .To only to recall products that have been the subject of a complaint.

.(D) .That once the company has informed the National Drug Regulatory Authority, the Government will be responsible for the recall.




11. A person responsible for executing a product recall:

.(A) .Only needs to be identified when the company is faced with the need to do a recall.

.(B) .Can come from anywhere within the company that the company can spare at the time.

.(C) .If different from the authorized person must make the authorized person aware of any recall.

.(D) .May not have any enough support staff so the inspector should check carefully that the recall has been completed efficiently.


12. Established written recall procedures are:
.(A) .Regularly checked and updated for the organization of any recall activity.

.(B) .Developed only when if the Government insists on a recall.

.(C) .Not required for very small-scale manufacturers.

.(D) .Only required in commercial factories but not in Government-owned manufacturing facilities.


13. Distribution records:

.(A) .Are only required for product shipped within our own country.

.(B) .Do not need to record any batch numbers if they go to wholesalers.

.(C) .Should include product shipped for export and sent out for use in clinical trials and as medical samples those who received samples for clinical trials and medical samples.

.(D) .Are only accessible to the distribution manager.


14. The progress of the recall process:

.(A) .Includes a reconciliation between the delivered and recovered quantities of the products.

.(B) .Does not need to be recorded unless a Government Inspector says so.

.(C) .Only needs to be recorded when the job is done and there is some spare time available.

.(D) .Is recorded only by the QC manager.


15. Recalled products:

.(A) .Can be stored anywhere in the main warehouse if the company has a validated computer quarantine system.

.(B) .Have to be kept within the quarantine area.

.(C) .Can be left outside the factory because they are not worth anything.

.(D) .Must be kept in a secure segregated area while their fate is decided.


16. An example of a defect which may result in a recall is based on investigation :

.(A) .One empty blister pack in a batch of tablets.

.(B) .A readily visible cosmetic package fault.

.(C) .A product labelled with the incorrect name.

.(D) .A product which fails its shelf life studies.




17. A customer complaint that may result in a recall is:

.(A) .Contamination on the outside of a package which has minimal risk to the patient.

.(B) .Microbiological contamination of a sterile product.

.(C) .A small mark on the tablet coating.

.(D) .Microbial contamination of a non-sterile product which may have medical consequences.


18. A company knows it has a recall situation when:

.(A) .The National Drug Regulatory Authority informs them.

.(B) .The company discovers from its ongoing stability programme that a product has become hazardous to patients.

.(C) .A customer complaint indicates that the product is dangerous to health.

.(D) .The National Drug Regulatory Authority finds that a counterfeit or tampered product is on the market in the company’s packaging.

.(E) .All of the above.


19. A product with a life threatening defect must be recalled:

.(A) .Within the next 48 hours.

.(B) .Anytime within the next 5 working days.

.(C) .By all reasonable means whether in or out of business hours.

.(D) .Immediately if a patient has died but otherwise in normal business hours.


20. Complaints received by a company concerning product quality:

.(A) .Are mostly generated by people who want stock replacement of their expired pharmaceuticals.

.(B) .May be dealt with by the company if other more important work has been completed.

.(C) .Should be regularly reviewed by the top management of the company to see if there are any trends emerging.

.(D) .Are an important source of information enabling product quality to be improved.



Test Paper 5 – GMP Training

Section – Complaints and Recalls

Answers


.1. .B

.2. .A

.3. .D

.4. .C

.5. .A

.6. .D

.7. .C

.8. .B

.9. .B

.10. .B

.11. .C and D

.12. .A

.13. .C

.14. .A

.15. .D

.16. .C and D

.17. .B and D

.18. .E

.19. .C

.20. .C and D


I HOPE THIS TEST WILL REALY HELP YOU TO INCREASE YOUR KNOWLEDGE ON GMP

Following are some of articles which;will be useful for you in further understanding of aspects of sterile dosage form manufacturing

Pharmaceutical Validation

Cleen Room Classification

Pharmaceutical Industry

Pharmaceutical Manufacturing

Clinical Trials

Pharmaceutical

To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies

Like This Website on Facebook and Stay Connected Share This Article with your Friends




Latest Pharma Update

USFDA approves first drug Inmazeb to treat Ebola Virus Infection

US FDA approved first drug to treat Ebola Virus Infection (zaire ebolavirus) . So far there was no drug treatment available for Ebola virus ...

You May Also Like

If you are looking for latest Pharmaceutical Manufacturing Guidelines of USFDA, UKMHRA, TGA WHO GMP then this website is one of most popular source.
Subscribe to this website by providing your email


Enter your email address get latest Pharma Guideline and technology update by email whenever this website is updated