Question { Dishman, 20631 }

what is difference between method validation and method
verification

Answer

Method Validation: It is performed either when method is non-compendial or any changes has been made in a compendial method. only few parameters shall be validated if any changes has been in a compendial method.
Method verification: It is performed when method is compendial and only few parameters have to be checked as before implementing these method in a monograph, pharmacopoeia usually validate the method. only thing to be checked is the suitability of the method.

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Question { XYZ, 23005 }

difference between temporary change control and deviation

Answer

Temporary change control and deviation
Change control: It is a documented procedure wherein we can make changes in an approved procedure, process, equipment, method for better improvement without impacting the product quality and before implementing such changes, approval of Quality unit must be needed.All the changes made through change control procedures are PERMANENT, they are not TEMPORARY.
Deviation: There are two types of deviations
Unplanned: It is the situation where we did not follow the written procedure which is against cGMP. in such cases a deviation is need to be filed and investigation must be done and accordingly CAPA must be taken.
Planned: It is the situation where we can not follow the written procedure due to technical problem and we must deviate the procedure to process further. such planned deviation must be minor in nature and are for TEMPORARY only. Before making any planned deviation, Impact assessment shall be done. If we want to make such changes permanent then change control procedure must be used.
or we cannot follow (planned) the approved procedure to p

Question { Cadila, 23209 }

What is GMP, GLP?????????

Answer

GMP : It is an abbreviation of Good manufacturing practices. These practices are applicable when a drug manufactured for human being . This is a system by which it is ensure that the products are consistently manufactured and are controlled by quality standards.
GLP : It is an abbreviation of Good Laboratory practices and it is applicable for non-clinical research laboratories. GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.

Question { Rakshit Drugs, 2236 }

Difference between Change control and Deviation please give the answer elaborately

Answer

Change control: It is a documented procedure wherein we can make changes in an approved procedure, process, equipment, method for better improvement without impacting the product quality and before implementing such changes, approval of Quality unit must be needed.All the changes made through change control procedures are PERMANENT, they are not TEMPORARY.

Deviation: There are two types of deviations Unplanned: It is the situation where we did not follow the written procedure which is against cGMP. in such cases a deviation is need to be filed and investigation must be done and accordingly CAPA must be taken. Planned: It is the situation where we can not follow the written procedure due to technical problem and we must deviate the procedure to process further. such planned deviation must be minor in nature and are for TEMPORARY only. Before making any planned deviation, Impact assessment shall be done. If we want to make such changes permanent then change control procedure must be used.