INSPECTION OF DRUG DISTRIBUTION
CHANNELS
ByO.SASIVARDHAN,Y15MPH326,ACHARYA NAGARJUNA UNIVERSITY UNIVERAITY COLLEGE OF PHARMACEUTICAL SCIENCES,
CONTENTS 1.Drug inspectors
A. QualificationsB. Organizational aspectsC. Methods of inspection D. Reference/information sources
2.Inspection of establishments in the drug distribution chainE. ObjectiveF. InspectionsG. Special category of drugs
Drug Inspectors
1.A.Qualifications Inspectors should normally be pharmacists who have
working experience in community and/or hospital pharmacy.
Where persons other than pharmacists , they should be adequately experienced in drug control affairs and suitably trained in inspectorate functions
The inspector should possess the following attributes.I. Good knowledge of pharmacy, drugs, laws and
regulations to be enforcedII. Good knowledge of technical terms and excellent
communication skills
The inspector should possess the following attributes.I. Maturity, honesty and integrityII. Willing to accept challengesIII. Ability to organize their own work with minimum
supervisionIV. Ability to hold discussions with company
management at the completion of inspectionV. Ability to motivate othersVI. Commitment to hard work and long hours
Organizational Aspects Inspectors should be embedded in an organization, usually
called an inspectorate, which ensures the following aspects A job description which describes the duties of the inspector. Inspector should report either to regulatory authority or to the
pharmaceutical department of the ministry of health. Inspector should work according to a work plan and standard
operating procedures.Inspection reports should preferably be in three or four parts Date of inspection and general information on the
establishment inspected, Description of the inspection activities undertaken, including
analytical data of sample taken, Observations and recommendation's, Conclusion.
Methods Of Inspection
The inspector uses different methods to check compliance with the national, supranational or international drug laws and regulations
They are mainly,1.Comprehensive inspection
2.Concise inspection3.Follow up inspection
4.Special inspection5.Investigative inspection
1.Comprehensive Inspection
This form of inspection is generally reserved for a new pharmaceutical establishment
When establishment is applying for permit to extend its scope of operations beyond that for which it was originally licensed,
Has made important changes in key personnel or is changing premises,
Has not been inspected for a long time , This inspection should be announced.
2.Concise Inspection
This inspection can be reserved for establishments that have previously been inspected with view of assessing standards of good pharmacy practice
The outcome of the inspection will help in proper assessment of the establishment
The inspection may be unannounced.
3.Follow Up Inspection This is the inspection can be carried out to ensure that
corrective measures have been undertaken following advice and notice given during a previous inspections.
Time limit was given form applying the corrective measures the inspection may be unannounced
4.Special Inspection This is undertaken to deal with specific complaints received
about lapses or non compliance with standards of professional practice.
The inspection should be unannounced.
5.Investigative Inspection
This type of inspection is used to assess the performance of a new establishment whose scope of operation was previously unknown
Reference/Information Sources
Reference/information sources of an investigator should include:
Existing national and international drug laws and regulations, covering such aspects as
Licensing Gmp Good distributing practice Good pharmacy practice Promotion of pharmaceutical products Codes of inspection Codes of professional ethics.
2.Inspection Of Establishments In The Drug Distribution Chain
• ObjectiveInspection of establishments undertaken to ensures
Protection of patients and members of public from malpractice by distributors and suppliers of drugs.
High ethical and professional standards of pharmaceutical practice.
• Inspection when inspecting the establishments the inspector uses
appropriate references. The method of inspection should be laid down in a SOP
• Special categories of drugs when special categories of drugs are present the inspector
may require a modified SOP.
REFERENCES1.Good manufacturing practices for pharmaceutical products.
in:who expert committee on specifications for pharmaceutical
preparations. thirty second report geneva, who,1992,annex1.
2.Guiding principles for small national drug regulatory authorities.
in:who expert committee on specifications for pharmaceutical
preparations. thirty second report geneva, who,1990,annex6
3.Provisional guidelines on the inspection of pharmaceutical
manufactures in:who expert committee on specifications for
pharmaceutical preparations. thirty second report geneva,
who,1992,annex2.
THAN Q
Top Related