Pharmaceutical Products Quality Assurance Consultant (International)

Work   Assignments Overview

Deliverables/Outputs

Delivery Deadline

1. Local procurement of pharmaceutical products

Activity 1.1:

Identify the list of specific pharmaceutical products that need to be considered for local procurement.

1.1 List of pharmaceutical products selected for local procurement submitted.

31^st March 2024

Working Days: 5

Activity 1.2:

Conduct product specific market survey and evaluate the potential suppliers of pharmaceutical products, and check their National regulatory registration status, and conduct a thorough evaluation of their capabilities and compliance with the regulatory requirements.

1.2 Product specific market survey conducted for potential local suppliers, and report submitted.

30^th June 2024

Working Days: 30

Activity 1.3:

Collaborate with National Regulatory Authority and WHO: Work closely with National Regulatory Authority and WHO to gather all the necessary documents and information required for the product assessment for local procurement.

1.3 All the necessary document and information related to the product assessment collected and submitted.

30^th June 2024

Working Days: 9

Activity 1.4:

Prepare Documentation and Application: Prepare all the required documentation, including product registration certificates, quality control documentation, and any other necessary paperwork. Accurately fill out the application form provided by UNICEF-SD to request for local procurement authorization for the selected pharmaceutical products.

1.4 Application document that filled correctly prepared and submitted with all the required documents.

31^st August 2024

Working Days: 30

2. Pharmaceutical products procured by UNICEF Implementing partners meet the required quality standards.

Activity 2.1:

Identify and outline the quality requirements and standards set by National Regulatory Authority, WHO/UNICEF for the local procurement of quality pharmaceutical products

2.1 The requirements and standards set by National Regulatory Authority, WHO/UNICEF for the quality assurance and control of the local procurement of pharmaceutical products described and submitted.

30^th March 2024

Working Days: 10

Activity 2.2:

Ensure that all pharmaceutical products procured locally by UNICEF Afghanistan Country Office and/or implementing partner meet the required standards and specifications set by National Regulatory Authority, WHO/UNICEF.

2.2 Submission of assessment report with the detail specifications that aligned with the standards for all pharmaceutical products procured by UNICEF implementing partner.

From April 2024 up to the end of the contract

Working Days: 15

Activity 2.3:

Monitor the compliance of UNICEF Implementing partners with National Regulatory Authority and WHO/UNICEF requirements, as well as their adherence to the UNICEF Standard Operating Procedure (SoP) outline the quality requirement for the pharmaceutical procurement.

2.3 Submission of report on the verification of compliance of UNICEF Implementing partners with the requirements of the National Regulatory Authority and WHO/UNICEF as well as the UNICEF Standard Operating Procedure (SoP).

From April 2024 up to the end of the contract

Working Days: 15

Activity 2.4:

Maintain a copy of all documentation for the registration and importation of all pharmaceutical products procured locally by UNICEF and UNICEF Implementing Partners.

2.4 A soft and hard copies of registration and importation documents submitted by suppliers are kept at UNICEF Afghanistan Country Office for all pharmaceutical products procured by UNICEF and UNICEF Implementing Partners.

From April 2024 up to the end of the contract

Working Days: 14

Activity 2.5:

Verify that the documents submitted by the local supplier for the specific pharmaceutical products adhere to the requirement of the National Regulatory Authority and WHO and the local suppliers are registered in Afghanistan. Additionally, ensure that these documents are authenticated by the National Regulatory Authority.   

2.4   2.5 (a). All documents submitted by the local suppliers are verified and authenticated by National regulatory authority.

(b) All local suppliers from whom the UNICEF implementing partners procure pharmaceutical products are registered by National Regulatory Authority.   

From April 2024 up to the end of the contract

Working Days: 10

3. Monitoring

Activity 3.1:

Conduct regular monitoring at central, provincial and health facility levels of UNICEF implementing partners to ensure compliance with quality assurance and Good Storage and Distribution Practice (GSDP) using the UNICEF Pharmaceutical products management and quality assurance check list which is attached to the Standard Operating Procedure (SoP).

3.1 Submission of Monitoring report.

From April 2024 up to the end of the contract

Working Days: 60

Activity 3.2:

Conduct routine sample evaluation (physical quality check including assessing the package, physical appearance, and batch numbers) for pharmaceutical products delivered from different suppliers and asses the handling, storage, distribution, and proper recorded in the inventory control system.

3.2 Develop a tracking tool and submit reports for the sample evaluation of selected pharmaceutical products.

From April 2024 up to the end of the contract

Working Days: 30

4. Capacity building

Activity 4.1:

Develop a training program in collaboration with WHO and local partners focused on pharmaceutical quality assurance system for Service providers and organize and provide the training sessions.

4.1 Training program developed and provided on pharmaceutical quality assurance system for UNICEF implementing partners.

Quarterly: From April 2024 up to the end of the contract

Working Days: 15

Activity 4.2:

Provide on the job training to UNICEF implementing partners staff members, specifically on pharmaceutical products management and quality assurance.

4.2 Customized on-the-job training provided for the specific implementing partner.

From April 2024 up to the end of the contract

Working Days: 0

Activity 4.3:

Organize experiences and best practices sharing sessions between SPs.

4.3 Facilitation of knowledge sharing and submission of report on best practices sharing sessions conducted among UNICEF implementing partners.

Quarterly: From April 2024 up to the end of the contract

Working Days: 10

5. Coordination with National Regulatory Authority and WHO.

Activity 5.1:

Establish regular communication with the National Regulatory Authority for updated procedures and requirement and closely work with them to ensure the quality assurance of pharmaceutical products procured locally.

5.1 Regular communications, meetings, and sessions with the National Regulatory Authority, WHO and other local partners are established in relation to quality assurance of local procurement.

From April 2024 up to the end of the contract

Working Days: 9

Activity 5.2:

Collaborate with WHO on the capacity building initiatives aimed to enhance National Regulatory Authorities capabilities in quality assurance.

5.2 Report on capacity building activities conducted in collaboration with WHO.

Quarterly: From April 2024 up to the end of the contract

Working Days: 9