ABOUT US: 

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. USP’s focus on global public health extends to lower and middle-income countries with work in over 20 countries through donor-funded programs. Our programs are focused on building the capacity of regulatory authorities and manufacturers in ensuring patient access to quality-assured essential medicines by providing: 1) Technical assistance to manufacturers to increase the supply of quality-assured priority medicines for malaria, HIV/AIDS, tuberculosis (TB), neglected tropical diseases (NTDs), and maternal, newborn, and child health (MNCH) products; and 2) capacity-building activities to regulatory authorities to fulfill their function in ensuring the supply of quality-assured medical products.

PQM+ & COVID-19

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, and dietary supplements manufactured, distributed, and consumed worldwide. In Pakistan, Promoting the Quality of Medicines Plus (PQM+) Program, is a Cooperative Agreement between the United States Agency for International Development (USAID) and USP. This cooperative relationship supports Drug Regulatory Authority of Pakistan (DRAP) for regulatory reforms, quality assurance systems and strengthening the quality control laboratories in Pakistan. Moreover, PQM+ also provides technical capacity building in close coordination with DRAP and provincial health authorities.

ACTIVITY OBECTIVE:

PQM+ team intends to hire a consulting firm to provide support for ISO 13485 certification for selected PPE manufacturing facilities (Lahore-Sialkot-Karachi-Faisalabad-Hyderabad) - from EOIs received under the current PQM+ COVID-19 project. The consulting firm is expected to perform the activities mentioned in the scope of work provided below:

1. To provide technical support and mentorship in the planning, implementation, and reporting of: assessments, audits, and accreditation-ready inspections of selected PPE manufacturing facilities against ISO 13485 standards.
2. To provide advisory services to the teams on the development and implementation of continuous improvement initiatives upon request, with reference to ISO 13485.
3. In close collaboration with the management team, lead the follow-up of needed corrective and preventive actions following audits, along with the application of root cause analysis principle and process.
4. To take an active role in developing Quality Manual, policies, procedures/SOPs, and operation guidelines with reference to ISO 13485 or any other applicable standards.
5. To prepare training materials on PQM+ format and deliver training to PPE manufacturers.
6. To prepare a step-wise approach for the development of a quality management system at the facility.
7. To develop a safety manual to ensure safe working practices and occupational health safety standards with reference to ISO 13485 standards in manufacturing facilities.
8. To conduct a mock audit for ISO 13485 and prepare CAPA Plan with implementation.
9. To follow up with management to meet CAPA timelines for preparation of final assessment/audit.
10. To prepare the manufacturing facility for successful pre-assessment and final assessment by PNAC or equivalent authority for ISO 13485.
11. To coordinate with accreditation body for final assessment/audit
12. To assist with preparation of CAPA for final assessment/audit observations.
13. To follow-up with management for completion and submission of CAPA in given timeframe
14. To obtain Certification/Accreditation of facilities

MANDATORY DELIVERABLES:

• Pre-assessment reports for PPE manufacturers
• Facility assessment reports for ISO 13485 Audit
• CAPA plans against pre-assessment & final assessment.
• List of all procedures/SOPs or any other document developed or reviewed.
• Training Materials
• ISO 13485 Certification of the facility

MINIMUM REQUIREMENTS 

1. At least 05 Years’ experience in relevant field.
2. Having experience of ISO 13485 certification of firms/organizations.
3. Hands-on experience and work, with an understanding of ISO certifications, preferably ISO 13485.
4. Have experience of auditing for ISO 13485 or any other ISO Certification/Accreditation
5. Demonstrated ability in developing policies, regulations, and guidelines related to ISO Requirements.
6. Demonstrated ability to collect and interpret quantitative/qualitative information, with analytical problem-solving.
7. Proven leadership skills in consulting, with demonstrated experience in training and mentoring staff and others.

PERIOD OF PERFORMANCE 

The scope of the work defined herein should be implemented before 30th June 2021. The assignment will be required 28 Working Days Level of Effort (LOE).

GEOGRAPHIC AREA

Selected firm/ individual will develop and work in consultation with the USP Pakistan team and deliver certification of selected PPE manufacturing facilities situated at Lahore, Sialkot, Faisalabad, Hyderabad, Karachi.

REPORTING

Selected firm/ individual will report to the PQM+ Deputy Chief of Party.

EVALUATION CRITERIA

1. Past Experience - 30% 
2. Qualification and Education - 30% 
3. Financial Proposal- 40% 

IMPORTANT NOTE

The Consultant (Firm/Individual) is required to have the aforementioned professional and technical qualifications. Only the applicants who hold these qualifications will be shortlisted and contacted.

Please send CV/Profile, 3-References, and Daily Rate by downloading the following ANNEX – D (Template):

https://drive.google.com/file/d/1SNQftPHB25vpRZTcznnsDrFRB8d2r7d1/view?usp=sharing

The Quoted Per Day Rate should be inclusive of all applicable taxes, traveling and any other associated costs.

Kindly send all Technical and Financial Proposal to ATTN:  USP Pakistan Procurement at [email protected] before the closing date April,14^th 2021. When submitting your application, write "ISO-13485 Certification for PPE Manufacturing Facilities - Pakistan" in the email Subject Line.