Monday, June 17, 2013

What is validation? What is the importance of validation in pharmaceutical industry?



1.      What is validation? What is the importance of validation in pharmaceutical industry?
Validation is a documented evidence which provides a high degree of assurance that a specific process, method or system will consistently produce to the required specification in accordance with accepted standards of cGMP.
Importance of Validation :
a)In pharmaceutical industry the validation is required for national or international regulations
b) Validation is a part of integrated requirements of a quality system
          c) Validation meets the consistency of quality product in all stages

2.      What do you mean by Prospective, Retrospective and Concurrent validation?

Prospective  : A prospective process validation states that three consecutive marketed batches are manufactured & tested as per prospective process validation SOP. Validation data has generated by validation committee. When all data are fully satisfied then this product are released for sale & called this process is validated to use routinely in production.

Retrospective : A retrospective process validation are performed by documenting all the historical information of existing 10 products using trend analysis data in QCMS system & its ensures that the existing process is under control.

Concurrent validation : Concurrent validation is carried out during routine production. This method is effective only if the development stages have resulted in a proper understanding of the fundamental of the process. Some manufacture refers the concurrent validation as Prospective process validation.


3.      Write the basic requirements of cGMP/GLP?
Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorization or product specification.
Good Manufacturing Practice is concerned with both production and quality control. The basic requirements of GMP are that -
a. appropriately qualified and trained personnel;
b. adequate premises and space;
c. suitable equipment and services;
d. correct materials, containers and labels;
e. approved procedures and instructions;
f. suitable storage and transport;

4.      What do you mean by DQ, IQ, OQ, &  PQ ?
Design Qualification (DQ): documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose.

Installation Qualification (IQ): documented verification that the equipment or systems are installed or modified &  comply with the approved design of the manufacturer’s recommendations and/or user requirements.

Operational Qualification (OQ): documented verification that the equipment or systems are installed or modified & perform as intended throughout the anticipated operating ranges.

Performance Qualification (PQ): documented verification that the equipment and ancillary systems are connected & can perform effectively and reproducibly based on the approved process method and specifications.



3 comments:

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