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Inspection
Posted on June 12, 2008. Filed under: CGMP | Tags: Inspection, Inspectors, Types of Inspection |
Inspection
Prof. Manohar A. Potdar
Head of Quality Assurance Department, Poona College of Pharmacy, Pune, India
potdar_manohar@yahoo.com.au
Inspection means the control and enforces compliance with general Good
Manufacturing Practices or we can say to authorize the manufacture of specific
pharmaceutical products normally in response to a licensing application.
In pharmaceutical field the inspection of manufacturing & Quality Control
facilities are to be done prior to marketing authorization for the product to be granted.
Inspector may be the independent person or a group of person who review the
quality system of a company in compliance with the standards issued by the
International Organization for Standardization (ISO 9000-9004) or British Standards
Institution (BS 5750) with other equivalent National Standards.
Inspector’s requirements
Good Inspector
Experience concerning usage and quality problems
Good communication with staff of all levels
Experience of the components manufacturing process
Full understanding of G.M.P. & legal requirements
Familiar with general manufacturing standards operated in industry concerned
Prepare in advance of visit
Realistic prepared to listen
Responsibilities of an Inspector:
An inspector should present a detailed factual report on standards of manufacture and
control applied to specific products. However, inspection should not be limited to
compilation of an inventory of faults, irregularities, and discrepancies. Provided it is in
keeping with national policy and does not breach understandings regarding
confidentiality of information having commercial value, advice may be offered on how
production and control procedures can be usefully upgraded. An inspector should
always be expected, to offer advice on how to improve an in-process test procedure or
to offer other assistance which, in his or her opinion. An inspection should be regarded
as an opportunity to assist and motivate a manufacturer to comply with GMP and to
correct any specific deficiencies.
Types of inspections:
Routine inspection
This is a full inspection of all relevant components of GMP and licensing requirements.
It may be indicated when the manufacturer is newly established or requests the renewal
of a license or he has introduced a new product, or has made a significant
modifications to the manufacturing methods or has made some changes in key
personnel, premises, equipment, etc.;
Concise inspection
Manufacturers with reliable records of compliance with GMP in the course of previous
routine inspections are appropriate for concise inspection. The heart of a concise
inspection is on a partial number of GMP requirements chosen as indicators of overall
GMP recital, with respect to the identification of any noteworthy changes that could
have been introduced since the last inspection. Cooperatively, the information obtained
will indicate the overall attitude of the firm towards GMP. Evidence of unsatisfactory
GMP recital observed throughout a concise inspection should set off a more
comprehensive inspection.
Special inspection
Special inspection are generally carried by visits which may be essential to carry out
spot checks for following complaints or recalls associated to supposed quality defects in
products. Reports of adverse drug reactions may also point out that all is not well. Such
inspections may be focused on one product, a group of related products, or specific
operations such as mixing, sterilization, or labelling. Special visits may also be made to
set up how a specific product is manufactured as a precondition for marketing approval
or issuance of an export certificate. A supplementary reason for special visits is to
congregate specific information on or to investigate specific operations and to advise
the manufacturer of regulatory requirements.
Inspection procedures
The GMP inspectorate should have the necessary resources such as financial, human,
facilities and documented procedures to allow the inspection of manufacturing
operations to be carried out in accordance with the general requirements of the WHO
guidelines on GMP and/or the national GMP guidelines. The GMP inspectorate should
require the manufacturer to have documented procedures in accordance with a quality
management system, and complying with the WHO guidelines on GMP and/or the
national GMP guidelines. The GMP inspectorate should perform regular inspections of
the manufacturing premises, procedures and quality systems of authorization holders at
least once every 2 years in accordance with a written inspection programme. Written
inspection reports should be prepared and sent to the national regulatory authority to
keep it informed of the outcome of such inspections. The arrangement of inspections of
manufacturers and the evaluation of compliance with the planning concerning the
performance of the different types of inspections should be documented. The types of
inspections should include as a minimum routine inspections, specific inspections,
follow-up inspections and concise inspections.
INSPECTION
What the inspector expect and keep in his mind during his inspection according to
W.H.O. and how we can prepare for the same?
There are following things in the mind of inspector. These are classified section wise as
follows: