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