Based on Section 51 of the Tanzania Medicines and Medical Devices Act, Cap 219, medicines registered in the country are those manufactured by premises and operations that comply with Good Manufacturing Practices requirements.
Therefore, human pharmaceutical manufacturing facilities which includes domestic and foreign facilities intending to market products in the country are required to meet the East African Community (EAC) GMP compendium. To see the Guidelines, Click here.
GMP requirements for human pharmaceutical facilities differ slightly from those of veterinary pharmaceutical facilities. The GMP requirements for veterinary pharmaceuticals manufacturing facilities are found in the Good Manufacturing Practices Guidelines for Veterinary Medicinal Products. To see the Guidelines for veterinary manufacturing facilities, Click here.
In order to verify compliance to GMP requirements there are four types of inspections that can be conducted; routine inspection, concise inspection, follow-up inspection and Special inspection. For more details on each type of inspection refer Inspection and Enforcement Section.
Generally TMDA GMP inspections must be conducted by at least two inspectors; one of them is the lead and the other is the co-inspector.
TMDA recognizes all reports for manufacturing facilities that were inspected under EAC and ZAZIBONA.
Some facilities will be required to submit documents so that Desk Review could be performed to determine their compliance to EAC GMP requirements. The facilities that are eligible for desk review are as follows;
- Located in countries with Stringent Regulatory Authority (SRA) or approved by WHO Listed Authorities (WLA) as follows;
- Founding regulatory members of the International Conference on Harmonization (ICH) namely European Commission (EC)/European Medicines Agency (EMA), Japan and United States of America; or
- Standing regulatory members namely Health Canada and Swiss Medics (or as may be updated from time to time and approved by TMDA).
- Regulatory members namely Health Science Authority (HSA) Singapore, the Therapeutics Goods Administration (TGA) Australia and Agencia Nacional De Vigilancia Sanitaria (ANVISA) Brazil.
- Inspected and approved by World Health Organization (WHO) under Medicines Prequalification Program.
Application for GMP Inspection of non- domestic facilities:
Non domestic manufacturing facilities should be registered by their respective National Medicines Regulatory Authorities before applying for Good Manufacturing Practices (GMP) inspection in Tanzania mainland.
The application for GMP inspection should be submitted by filling the GMP Inspection application form. To access the form, Click here . To apply for GMP inspection online Click here. This must be accompanied with proof of payment of GMP inspection fees and current site master file. For fees and charges regulation Click here.
Application for GMP inspection of domestic manufacturing facilities
For each facility, inspection is done at least once per year. The GMP inspection for already established domestic manufacturing facilities is conducted after they apply for renewal of business permit every year before 30th June. Applications for renewal of business permits are processed by the TMDA zone offices by submitting a dully filled in application form Click here to access the form. For online application Click here. To link with the zones Click here.
The basis for GMP inspections for both domestic and non-domestic manufacturing facilities is the EAC GMP compendium.
However GMP Inspection of Hospitals and Pharmacies compounding Medicinal Products will be based on minimum GMP requirements which are detailed in the respective guidelines Click here. Hospitals and Pharmacies are required to submit their applications for compounding to TMDA in writing. After being permitted to compound, the annual GMP inspections are conducted without receiving any application.
The procedure for overseas GMP inspections, begin with Inspectors courtesy call (where it is possible) to the Tanzania High Commission and National Drug Regulatory Authority (NDRA) The inspection is expected to conducted in the presence of an observer from NDRA of the country where inspection is done.
For domestic facilities, inspection begins with paying courtesy call to Regional Medical Officer and/or TMDA Zone Manager.
Upon arrival to the inspection site, the Inspectors (must be minimum of two) identify themselves at the entrance of the site before entering the site.
All inspections are started with an opening meeting. Inspectors convene a pre-inspection meeting with the inspectee and highlight important issues of the inspection. Then they circulate the attendance record form Click here to see the form to enable all persons present to record names, positions in the company and email address.
Inspectors then confirm the inspection plan provided. The plan is to be agreed by both parties prior to inspection. Adjustment of the inspection plan can be made if necessary. The lead inspector should preside the meeting.
The inspectors ask the inspectee documents for review Click here to see list, to be gathered in one central location for subsequent review. The inspectors also walk through every section of the plant and carefully review record and areas of the manufacturing sites.
During walk through the inspectors adheres to the EAC GMP Guidelines and take notes whenever necessary. Emphasis is placed on specific areas based on a risk approach and time allocated accordingly. Inspectors observe and document the actual status of the facility and not according to the intent or the future plan. The inspectors also verify selected source data where possible by requesting documentation, records and raw data.
Under the observations/comments sections, notes shall be recorded of status of conditions as a guide for improvements to be recommended.
Inspectors ask questions where appropriate (not necessarily as written in the checklist) and carefully listen to answers. Make observations of work-in-progress.
Inspectors cross-check with SOPs and records available for adherence, promptly record all observations and comments in a legible and retrievable manner in the checklist. Inspectors may also take photographs (upon permission of Inspectees) to support their observations.
After inspection the GMP inspectors shall convene a closing meeting and highlight issues as provided in Appendix IV and sign a memorandum form with the inspectee. The inspectors shall list down all non-compliance findings in the memorandum form Click here to see the memorandum.
Inspectors then prepare GMP inspection report as per approved format. Inspectors shall ensure that critical and major observations included in the inspection report are cross referenced to EAC GMP Guidelines whenever possible.
Where more than one observation relates to the same basic quality system failure, the inspectors shall group and list them as a single observation, under the heading that reflect the basic system failure. Compliance observations shall be written first followed by non-compliance observations under each heading/sub-heading in a report.
Non-compliance observations shall be classified into ‘critical’, ‘major’ and ‘minor’ non-compliances depending on the criteria for classifying non-compliances as provided in the GMP Manual and GMP Guidelines. Click here to see the criteria for classifying non- conformance observations.
The typed and signed report attached with GMP inspection memorandum forms are then submitted to TMDA not later than 14 calendar days from the last date of inspection of the foreign and 7 calendar days for domestic plants. The report is submitted with its executive summary report written.
Upon receiving of the reports, a review meeting is prepared that involves Director of Medicines and Medical Devices and Managers (chairperson) from this directorate. Managers, may submit their comments on the inspection report before the review meeting.
In case any member is among the inspectors of the respective facilities under discussion he/she shall be a presenter of the inspection findings and appoint someone from his/her section to attend on his/her behalf.
The GMP inspection reports are reviewed on report clarity and classification of observations only. After the meeting, minutes are prepared and filed in the respective file. Inspectors revise and correct the reports as agreed in the meeting, print and sign the final reports for submission.
Within one month after inspection, the signed full inspection report is submitted to the inspectee along with the GMP certificate Click here to see the format of the Certificate and the covering letter to inform them about the outcome of the inspection. Validity for GMP certificate is three (3) years of which will call for re-application.
A summary of the findings for the facility is then submitted to the medicines registration department so that appropriate regulatory actions are taken on the application for registration or already registered medicinal product.
Recommended Regulatory Action(s) after GMP Inspection
Below is a table showing a set of regulatory actions that can be recommended by inspectors when making decisions on the outcome of inspections.
|S/N||Category of non- compliances||Regulatory action(s)|