Inspection and Enforcement
Section 106 of the Tanzania Medicines and Medical Devices Act, Cap 219 gives powers to inspectors to enter, at all reasonable time, any premises which are in the TMDA register and any other premises, stall, vehicle, vessel or conveyance for the purpose of enforcing compliance with the Act.
Therefore, premises that are subject to TMDA inspection include pharmaceutical manufacturing facilities, Medical Stores Department (MSD), importers of veterinary and human pharmaceuticals, wholesale and retail pharmacies, Accredited Drugs Dispensing Outlets (ADDOs), hospitals, health centers , dispensaries, Port of Entries (PoE) and veterinary clinics.
The inspections conducted in these facilities can be special or investigative, concise inspection, routine inspection, follow up inspection or re-inspection and audit inspection.
Routine inspections entail full review of all aspects and components within a facility. They are generally intended for:-
- A new establishment
- An establishment that has applied for a permit to extend its scope of operations or made important changes in its key personnel or changed to new premises
- An establishment that has not been inspected for a long time
- An establishment with consistent records of non-compliances.
This inspection should be announced except when it has not been conducted for a long time, an unannounced inspection would be the norm.
Concise inspection is the evaluation of limited aspects relating to compliance of a facility. A limited number of requirements are selected by the Inspector to serve as indicators of the overall compliance of a facility. The Inspector also has to identify and evaluate any significant changes that could have been introduced by a facility since the last inspection.
Collectively, the selected indicators and the changes identified indicate facility’s attitude toward compliance to requirements. A concise inspection is conducted under the following circumstances: -
- Where premises have a consistent record of compliance with routine inspections in the past.
- Where a sample of aspects can be taken as a good indication of the overall level of compliance with requirements.
However, if the concise inspection uncovers evidence that the level of compliance has fallen, a more comprehensive or full inspection is performed soon after the concise inspection. These inspections can be announced or unannounced.
A follow up inspection is also referred to as a re-inspection or a reassessment of a premise. It is carried out to ensure that corrective measures have been undertaken following advice and notice given during a previous inspection. Depending on the nature of the defects and the work required, the follow-up inspection could be carried out between 7 days and 12 months after the previous inspection. Where a time limit was given to rectify the non-conformance, the inspection should be unannounced.
A special inspection is undertaken to do spot checks which could focus on one product, a group of related products, or specific operations e.g. false labeling. This inspection is unannounced. It is conducted under the following circumstances: -
- When there are complaints about a specific product
- To gather specific information, or to investigate specific operations of a facility.
Audit inspections are carried out to guide, support and assist audited part in carrying out inspection activities. The aim of audit inspection is to determine effectiveness, correctness and efficiency of the inspection activities and it covers all areas that inspection activities are carried out. Audit inspection helps to: -
- Ensure uniformity in conducting inspections
- Enhance compliance with legal requirements
- Assist Inspectors in improving their performance
- Identify problems and institute timely interventions
- Maintain and reinforce the administrative and technical links between higher and lower levels
- Make follow up of implementation of previous audit inspection recommendations
- Identify resource needs for inspection activities.
As a minimum requirement, audit inspection shall be conducted annually and is usually announced.
According to section 105 of the Tanzania Medicines and Medical Devices Act, Cap. 219, all drug inspectors who enforce medicines regulations have to be appointed by the authority and published in the gazette.
The actions which can be taken by inspectors include provision of advice, confiscation of unfit medicines and marking certain medicines by tape in order to prevent distribution.
Various tools are used by inspectors in the conduct of inspection. The tools include forms such as the sample, observation and confiscation forms. To see the forms, Click here.