Legal provisions

QC1: Does the country have a legal provision requiring analysis of drugs by government or other independent laboratories?

Yes
No

QC1.1: If yes, indicate the title and date of enactment and the article number of the provision:

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Organization

QC2: Does the DRA have its own quality control laboratory?

Yes
No

QC2.1: If yes, give the name, address and date of establishment of the laboratory:

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QC3: If no, does the DRA use other in-country or external drug quality control laboratories?

Yes
No

QC3.1 If yes, provide the names and addresses of other quality control laboratories used by the DRA:

QC3.2: If yes, do such laboratories also work for the private pharmaceutical industry’?

Yes
No

QC3.3: If yes, are contracts issued on the basis of a written agreement?

Yes
No

QC3.4: If yes, collect a copy of the agreement used?

Yes
No

QC5: Does the DRA’s quality control laboratory have the necessary facilities, materials and resources to carry out its functions?

Yes
No

QC5.1: If no, what are the main problems in terms of lack of equipment, human resources, supplies, funding, etc.?

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QC6: Does the DRA laboratory prepare its own working standards?

Yes
No

QC7: Do the functions of the DRA laboratory include the following?

Human resources

QC8: What is the number of staff working in the DRA laboratory(ies)?

QC8.1: Do the staff of the DRA laboratory have job descriptions?

Yes
No
Some have

Financing

QC9: Is there a specific budget for the DRA’s quality control laboratory?

Yes
No

QC9.1: If yes, what was the budget for the last five years (US$)?

QC9.2: What was the source of the budget in the last five years (answer yes/no)?

QC9.3: If the answer to QC9 is no, what is the estimated expenditure of the DRA quality control laboratory in the last five years?

QC10: If the DRA laboratory charges fees, indicate the fees charged for the various services provided:

Activities

QC11: Indicate below the number of drug samples submitted to the DRA laboratory for testing in the last five years, for each of the various sources of test requests listed:

QC12: Does the DRA laboratory also collect samples for testing?

Yes
No

QC12.1: If yes, indicate if it does so as part of planned quality surveillance and what kinds of products are targeted.

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QC13: Indicate below the activities of the DRA laboratory in the last five years:

QC14: Is the general level of substandard products known (e.g. from testing of random samples)?

Yes
No

QC 14.1: If yes, what is the general level of failure of samples tested for quality in the country?

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QC15: Indicate below the tests/assays methods performed by the DRA laboratory?

Monitoring and evaluation

QC16: Are the activities of the DRA laboratory based on a work plan?

Yes
No

QC16.1: If yes, obtain a copy of the most recent plan and provide information on the implementation rate:

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QC17: Is the DRA laboratory required to submit an annual report?

Yes
No

QC17.1: If yes, get a copy of the last report and/or information on the main findings of the report.

QC18: Does the DRA laboratory participate in schemes that show its level of performance compared to other laboratories (proficiency test)?

Yes
No

QC18.1: If yes, give details of the scheme (s) in which the laboratory participates:

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QC19: What are the main constraints, weaknesses or problems and the strengths of the DRA laboratory?

If there is any specific and important information that is not covered by the above questions, please provide additional information as appropriate.