Legal provisions

GIN1: What is the title and date of enactment of the drug legislation/regulations and the article number of the provision requiring GMP inspections?

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GIN2: Are there provisions in the drug law/regulations that define the powers and status of GMP inspectors?

Yes
No

GIN2.1: If yes, what are the powers of GMP inspectors?

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Organization

GIN3: Is there an GMP inspectorate?

Yes
No

GIN3.1: If yes, to whom does it report?

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GIN4: What is the relationship of the GMP inspectorate to the:

(a) Manufacturers’ licensing unit? ________________________
(b) Product registration unit? ____________________________

GIN5: Are there written national GMP guidelines?

Yes
No

GIN5.1: If yes, give reference to the title and date of publication of the guidelines:

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GIN5.2: Have the GMP guidelines been enacted as a law/regulations?

Yes
No

GIN6: Are there manuals or a standard operating procedure (SOP) for GMP inspectors?

Yes
No

GIN6.1: If yes, give reference to the date of publication of the SOP:

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GIN7: Are there procedures for the consideration of appeals against enforcement measures taken by the GMP inspectorate?

Yes
No

GIN7.1: If yes, to whom are appeals referred and what is the procedure for handling appeals?

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GIN8: Is there a job description pertaining to the duties and responsibilities of GMP inspectors?

Yes
No

GIN9: Is a GMP certificate issued to manufacturers of pharmaceutical products?

Yes
No

GIN9.1: If yes, is the certificate issued on a product basis or is it a general certificate? Explain.

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GIN10: How many pharmaceutical manufacturers have GMP certificates for export?

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Human resources

GIN11: How many GMP inspectors are there in the country (indicate if the inspectors also serve as inspectors of the distribution chain)?

(a) full-time employees ________
(b) part-time _________________

GIN11.1: If there are no GMP inspectors, who inspects manufacturing plants? Is the work contracted out? Explain.

________________________________________________________________

GIN12: Do the GMP inspectors receive training in GMP inspection/auditing?

Yes
No

GIN12.1: If yes, provide information on their qualifications, the type of training offered and their experience (number of years) as GMP inspectors:

GIN13: What is the average net salary of a GMP inspector compared to other categories indicated in the table?

Financing of GMP inspection

GIN14: Is there a specific budget for the GMP inspectorate?

Yes
No

GIN14.1: If yes, what was the budget of the GMP inspectorate during each of the last five years (US$)?

GIN14.2: What was the source of budget in the last five years (answer yes/no)?

GIN14.3: If the answer to GIN14 is no, what was the estimated expenditure of the GMP inspectorate in the last five years?

GIN15: Does the inspectorate charge fees?

Yes
No

GIN15.1: If yes, what fees are charged for the various inspection services?

GIN15.1: Is the inspectorate allowed to use the fees collected?

Yes
No

GIN15.2: If yes, what are the total fees collected in the last five years?

Activities

GIN16: Is there planned GMP inspection?

Yes
No

GIN16.1: If yes, what are the criteria for planned inspections? Obtain a copy of the criteria used if there is a written document; otherwise, collect the information.

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GIN17: What is the frequency of planned inspections?

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GIN18: Give below information on GMP inspections carried out in the last five years:

GIN19: What is the number of planned GMP inspections conducted in the last five years, out of total number of planned inspections targeted to be carried out in those years?

GIN20: Indicate below the number of manufacturing plants holding a GMP certificate (or complying with GMP), out of the total number of manufacturing plants in the country, in each of the last five years:*

* In some countries, GMP certificates are awarded on the basis of production categories or dosage forms (for example, capsule, injection) instead of a general certificate to manufacture. Please make a note if this is the case for this country.

GIN20.1: What are the major problems found/reported when pharmaceutical manufacturing plants do not comply with GMP?

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GIN21: Indicate in the table below the number of enforcement measures taken against manufacturing plants in each of the last five years for noncompliance with GMP requirements. (Please also describe any other strategies used for improving the level of GMP compliance in the country.)

GIN22: Are samples collected during GMP inspection of manufacturing plants and then tested? (Describe also any other strategies applied for checking the quality of products from local manufacturers.)

Yes
No

GIN22.1: If yes, indicate the number of drug products collected and tested during each of the last two years:

GIN23: Are there sanctions for products that fail laboratory tests?

Yes
No

GIN23.1: If yes, who is empowered to take action on the basis of the results of laboratory tests?

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GIN23.2: What actions/sanctions have been taken against products that failed laboratory tests in the last two years?

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GIN24: Is there a product recall system?

Yes
No

GIN24.1: If yes, indicate the number of recalls made per year in the last five years:

Monitoring and evaluation

GIN25: Is there an audit and/or review system to examine the performance of inspectors and the inspectorate?

Yes
No

GIN25.1: If yes, indicate whether this is external, internal or both:

________________________________________________________________

GIN25.2: Indicate below the actions that have been taken as a result of audits or reviews in the last five years:

GIN25.3: What are the main constraints, weaknesses or problems and the strengths of GMP inspection in the country?

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