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.
