What criteria is used to inspect? What is the reference standard/reference guidelines used for ZaZiBoNa inspections?

The World Health Organization’s technical reporting series guidelines are used as standards / reference guidelines for ZaZiBoNa inspections. However other guidelines like PIC(s) can be referred to. The collaborative initiative has also developed guidelines which can be located under the Guidelines section of the website.

What is the frequency for a routine inspection?

Routine inspection frequency is determined using a risk-based approach. The approach considers the nature of the dosage forms, complexity of the manufacturing process, previous inspection history and the number and nature of the noted shortcomings among other issues. The inspection frequency is therefore determined at the end of the previous inspection and may vary from 1 to 3years, based on risk.

Does ZaZiBoNa cover routine inspections?

ZaZiBoNa conducts routine inspections for sites that receive approval of their products through the collaborative process, for sites that were previously inspected under the initiative.

What is the validity period for a ZaZiBoNa inspection outcome?

The period of validity of a ZaZiBoNa inspection ranges from 1 to 3 years depending on the assigned risk. A risk-based approach which considers the nature of the dosage forms, complexity of the manufacturing process, previous inspection history and the number and nature of the noted shortcomings among other issues is used to determine the validity on a case-by-case basis

Do I get a GMP approval certificate from ZaZiBoNa?

GMP recognition and certification of a manufacturing facility after a ZaZiBoNa inspection is at a country level. After the inspection, each country is responsible for issuing GMP approval or certification in line with the recommended outcome and in line with national processes.

If I was inspected by another SRA would ZaZiBoNa accept that inspection as sufficient?

Facilities inspected by SRAs are subjected to desk reviews and this encompasses the review of the inspection report and compliance report, among other documents that should be submitted.

If I was inspected by one of the member states and not a joint ZaZiBoNa inspection, do I become eligible for a desk review by ZaZiBoNa?

Currently ZaZiBoNa only considers desk reviews for sites that would have been inspected by Stringent Regulatory Authorities. This position is anticipated to be in force until such a time when the ZaZiBoNa initiative reaches mutual recognition

If I was inspected by a ZaZiBoNa member state, will I be inspected again?

It should be noted that the ZaZiBoNa initiative is still at work sharing and capacity building stage, therefore inspections conducted by individual member states are not yet being considered for approval of products being considered jointly under the initiative. The facility will therefore be subjected to a ZaZiBoNa inspection, where two or three member states participate regardless of the previous inspection history by any of the ZaZiBoNa member states.

If I was inspected by one member state, does ZaZiBoNa or the other member states recognize the inspection/my cGMP approval?

Currently no, only joint inspections done under the ZaZiBoNa initiative can be recognized. However, the individual national agencies may consider the scope and outcome of these other inspections.

What are the benefits of participating in ZaZiBoNa joint inspections?

Joint inspections reduce the number of inspections performed at a facility resulting in potential saving in time and resources ordinarily incurred when a facility is subjected to multiple inspections by different regulatory Authorities. The outcomes of the inspections are generally accepted by all SADC Member States though each retains the right on the final approval decision.

What is the waiting period after requesting for an inspection?

The initiative conducts product-based inspections to support product registration, generally facilities are inspected within 6 months from the time of initial dossier review. However, it should be noted that ZaZiBoNa inspections are scheduled quarterly with 3-4 facilities being considered in each inspection schedule.

How is an inspection triggered?

As a manufacturer or applicant, you will receive a List of Queries after the initial review of your product. If the outstanding issues to be addressed include confirmation of GMP compliance through a site GMP inspection or a GMP Desk Review you need to contact the Joint Inspections Coordinator on SMutyavaviri@mcaz.co.zw and gmp@mcaz.co.zw. Correspondence on official manufacturer’s or applicant’s letterhead should indicate the following;

  1. Product name
  2. Manufacturing site, indicating manufacturing block
  3. Dosage forms manufactured on site
  4. The site contact person and email.

On receipt of the correspondence, a proforma invoice is issued by the Implementing Agency, MCAZ, indicating the Banking details and the fees to be paid.

What are the inspection fees? How and where do I pay?

The inspection fees are as follows;

  FACILITY TYPE  FEE (US$) Envisaged inspection days
1 Non-Sterile plant

(<3 dosage forms i.e. tablets & capsules and one other))

8,000 3

 

 

2 Sterile and special plant*

(NB: plant with svp and powders treated as 2 different plants)

10,000 3
3 Plant with 3 dosage forms 10,500 3 / 4
4 Plant with more than 3 dosage forms 12,000 4
5 Contract research organizations (CRO) 8,000 3

 

Inspection fees are paid to the coordinating agency, MCAZ, against a proforma issued by MCAZ.

Do I need to have submitted a DOSSIER to be eligible for ZaZiBoNa inspection?

Yes, a dossier should have been submitted for an applicant to be eligible for a ZaZiBoNa inspection. This is because ZaZiBoNa GMP inspections are done to support product registration.

How do ZaZiBoNa joint inspections work?

A ZaZiBoNa GMP inspection is conducted to support product registration.  A manufacturer to be considered for an inspection should have submitted dossiers for product registration in any two of the Active ZaZiBoNa countries. Currently product-based inspections are conducted.

Any two of the ZaZiBoNa countries and a third observing country will come for the onsite inspection.

How do I contact ZaZiBoNa and where are their offices?

The ZaZiBoNa project implementing agency is the Medicines Control Authority of Zimbabwe (MCAZ). Their address is;

106 Baines Avenue

Harare

Zimbabwe

All general correspondences are directed to the Director General-MCAZ, email address, mcaz@mcaz.co.zw;

Products evaluations and registration are directed to the Joint Assessments Coordinator, Mr F. Masekela on the following email address:

fmasekela@mcaz.co.zw;

GMP specific issues are directed to the Joint Inspections Coordinator, Mr S. Mutyavaviri on the following email address:

SMutyavaviri@mcaz.co.zw; gmp@mcaz.co.zw;

General project queries are directed to the SADC MRH Project Coordinator, Mrs S. Dube-Mwedzi on the following email addresses:

sakhi.vee@gmail.com; sadcproject@mcaz.co.zw

Country specific coordinators are as follows;

Country Inspections focal person
Botswana sphetlhu@bomra.co.bw
Democratic Republic of Congo jpbitilon2005@yahoo.fr
Malawi chrissychulu@gmail.com
Mozambique aossufo@gmail.com
Namibia Ester.Mvula@mhss.gov.na
South Africa karen.ford@sahpra.org.za
Zambia bkabaso@zamra.co.zm
Zimbabwe cdandira@mcaz.co.zw
Tanzania maganga.maganga@tmda.go.tz

Which countries are part of the ZaZiBoNa collaborative initiative?

The SADC Member States are involved at differing levels.

Active Member States (Countries that can apply a registration and inspection system by virtue of having in place national requirements and processes. They participate in product evaluation and manufacturing site inspection in accordance with agreed standards). These are:

  • Botswana
  • Democratic Republic of Congo
  • Malawi
  • Mozambique
  • Namibia
  • South Africa
  • Zambia
  • Zimbabwe
  • Tanzania

Non-active Members (Countries that do not actively participate in the joint assessment of products or the joint inspections). These are:

  • Angola
  • Eswatini
  • Comoros
  • Madagascar

Observers

  • Lesotho
  • Mauritius

What is ZaZiBoNa?

ZaZiBoNa is the collaborative medicines registration initiative for the 16 SADC Member States. ZaZiBoNa was established in 2013 by four countries, Zambia, Zimbabwe, Botswana and Namibia. Although the initiative has expanded beyond these four countries, the name ZaZiBoNa has been maintained because of its special meaning in Nyanja, one of the local Zambian languages: “look to the future”. More information including the background and objectives of the initiative can be found under “About us”. 

Q. Which products are considered under the ZAZIBONA collaborative procedure?

Products used in the treatment of the following conditions; HIV/AIDS, tuberculosis, malaria, acute respiratory infections, diarrhoea, diabetes, pneumonia, cardiovascular, cancer, obstetrics, gastroenteritis and colic, reproductive health products and products included in the list of United Nations Commission for Life-Saving Commodities for Women and Children Final UN Commission Report_14sept2012.pdf (unfpa.org)

Q. Can post registration variations be assessed via ZAZIBONA?

No. Variations are currently not being considered under ZaZiBoNa. Applications for variations are considered in the individual countries.

Q. What is the application cost?

The application cost varies with participating country requirements since the applicant is required to submit separate applications and pay the applicable fees to each member state that they intend to market their products.

Q. Is there a centralised application submission procedure?

No. It is currently not possible to submit applications centrally to ZAZIBONA. To be eligible for the ZAZIBONA collaborative process an application should have been lodged with at least to two (2) ZAZIBONA participating countries in line with national requirements

Q. How long does it take to register a product under the ZAZIBONA collaborative procedure?

ZAZIBONA does not register products but provides a recommendation for implementation by the countries. The products are registered in the respective member countries. The process of dossier assessment takes up to 12 months from when an application is submitted to when a recommendation is made. The time to registration is subject to the fulfilment of country specific requirements by the applicant and may vary however a target of not more than 90 days has been set.