Four common compliance challenges faced by pharmaceutical wholesalers and distributors in Africa

April 11, 2018

In 2017, PFSCM embarked on a campaign to pre-qualify pharmaceutical distributors and wholesalers in Africa, ensuring that we and others procure only the best quality, compliant products close to the point of care.

Last year, PFSCM audited more than 58 suppliers in eight African countries. In total, 37 (63%) of the 58 vendors passed the pre-qualification audits.

PFSCM Product Quality Assurance Unit Manager Stephen Kimatu explains that vendors are pre-qualified in accordance with the World Health Organization’s (WHO’s) Model Quality Assurance System (MQAS) for Procurement Agencies.

Audit results show that the majority of vendors scored less than 80% on the WHO MQAS pre-qualification and re-assessment criteria and/or failed on the Quality Control (QC) criteria for testing products in an ISO/IEC 17025-certified or WHO-PQ quality control laboratory.

However, these vendors do comply with the various general requirements specified in the WHO MQAS. These include quality management, organization structure, documentation, self-inspection, product recalls, security, and record-keeping; as well as complaint handling, and the handling of recalled, rejected, or returned goods.

Most vendors also scored sufficiently on purchasing or procurement practices and complied with specifications pertaining to the receipt and storage of purchased products.

Through ongoing engagement with vendors, PFSCM identified four key challenges faced by distributors and wholesalers in Africa:

 

1. Lack of awareness of WHO MQAS standards and sustained enforcement of cGDP

 

Many African countries enforce WHO Good Distribution Practices (GDP) standards for the receipt, storage, and distribution of products, but they neglect to legally enforce the complete WHO MQAS standards, which address the pre-qualification and reassessment of the suppliers and manufacturers they buy from.

In some countries, regulators undertake pre-qualification and reassessment of suppliers to some extent, but this alone is not sufficient to ensure utmost product quality and safety is maintained throughout the supply chain.

There also tends to be a greater focus on developing and enforcing regulations such as current Good Manufacturing Practices (cGMP) for pharmaceutical manufacturers than on regulations such as GDP for distributors and wholesalers.

A lack of active regulatory surveillance has resulted in some wholesalers lagging behind on even the country-specific GDP standards.

Common observations include:

  • Failure of routine inspections by regulatory authorities.
  • Absence of registered pharmaceutical personnel on the premises.
  • Lack of compliance with the national drug authority’s storage requirements, especially for narcotics and psychotropics.

2. Lack of specific QA expertise

 

Many wholesalers and distributors do not have a qualified quality assurance (QA) manager on staff or a quality policy in place.

As a minimum requirement, most companies employ a pharmacist, pharmaceutical technician or technologist to oversee the intake and storage of medicines, but these individuals do not necessarily have the applicable training to also focus on QA matters.

Investing in a dedicated quality manager will enable vendors to develop quality procedures and policies to become more compliant with WHO MQAS and GDP, as well as the use of ISO/IEC 17025 QC labs for testing.

Common observations include:

  • No dedicated QA manager.
  • Quality manuals that require improvement.
  • Lack of laboratory testing and testing plans or strategies.
  • Lack of quarantine areas.

3. Lack of a QMS

 

Many distributors and wholesalers do not have enough knowledge about a Quality Management System (QMS) and its benefits.

Implementing a QMS can be a challenging task with quite a bit of theory, documentation, and details to be created and checked. Such a task requires a professional in the field to ensure that the QMS is practical for the business, the document management is effective, the level of detail is suitable for the operation, staff and management are involved, and customer satisfaction remains the main focus.

In addition, Kimatu notes that many operations may disregard QMS because they find it hard to justify the initial investment.

“The return on investment for implementing QMS is complex. Rather than trying to explain a monetary return at a specific point in time, one should rather focus on the fact that the implementation of QMS will reveal areas for improvement, streamline business, integrate processes, and guide employees. These almost always result in savings, as costly mistakes are kept to a minimum and profit is driven by increased productivity.”

Some benefits of QMS include:

  • Better process control and integration.
  • Cost savings and reduced wastage.
  • Streamlined operations for business growth.
  • Increased market share.
  • More engaged staff and increased morale.
  • More effective marketing to exploit new sectors.
  • Continuous improvement of products, processes and systems.

Altogether, QMS increases consumer confidence and ensures safer products.

Common observations include:

  • Lack of standard operating procedures (SOPs) for key processes.
  • No review dates for SOPs.
  • Lack of self-inspection reports.
  • Lack of quality manuals.
  • Lack of designated quality managers.

4. Ambiguity in understanding the benefits of investing in infrastructure and other improvements

 

Even though many operations and infrastructure, such as warehouses, comply with local regulations and pass routine inspections, they still lack in compliance with global standards.

These businesses are sustained by local buyers (buying in compliance with local regulations), and therefore the businesses find the benefits of investing in improved infrastructure to gain international business ambiguous. Without upfront international procurement contracts, many local vendors are not easily persuaded to make the often significant investments required to upgrade systems and facilities.

This quandary continues, as global demand will not be stimulated without the availability of enough globally compliant local sources, while local resources will not invest in becoming compliant without the demand already existing.

Kimatu explains that even though this challenge remains extremely difficult, some industry-wide initiatives could set the ball rolling for improvement.

“A more standardized global approach to harmonizing standards may reduce the level of dissimilarity between regulations, systems, and procedures, thereby reducing the level of repeat effort and investment needed by each vendor to comply with various clients’ quality expectations. This could go a long way in helping vendors realize the benefits of international best practices.”

Further, the continued efforts of pooled procurement to aggregate demand may also aid in breaking down barriers.

Common observations include:

  • Lack of space, causing overstacking and hampering cleaning and inspections.
  • Lack of quarantine areas for received products or products awaiting a QA determination.
  • Lack of adequate warehouse to enable temperature mapping.
  • Lack of professional pest control services.
  • Lack of designated areas for damaged, recalled, returned, or expired goods.
  • Poor storage and distribution of some product categories, particularly cold chain products.
  • The importance of pre-qualifying in Africa

By pre-qualifying vendors in Africa, PFSCM is developing reliable sources of supply closer to the point of care, ensuring affordable, quality medicines are readily available to vulnerable communities. Through world-class audits, we are creating awareness and educating vendors about the benefits of quality compliance, opening their service to a wider network of international buyers.

“By expanding local compliant sources, we are developing local supply chains and local communities, while saving costs, reducing lead times, meeting our clients’ needs, and minimizing the environmental impact of international cargo shipment,” said Kimatu.

Through pre-qualifying vendors in Africa, we are:

 

  • Strengthening supply chains by expanding the pool of quality compliant and reputable distributors, wholesalers, and manufacturers.
  • Educating vendors about the global standards for procurement and distribution.
  • Helping vendors to identify opportunities for improvement.
  • Inspiring vendors to achieve compliance in order to expand their market share and aid in developing local economies and public health supply chains.
  • Ensuring that PFSCM and its clients have access to more vendors in Africa, minimizing the challenges of global procurement and distribution, which include production delays, shipping lead times, funds spent offshore, and carbon footprint.
  • Ensuring lifesaving commodities are readily available to some of the most vulnerable and hard-to-reach communities in Africa.

PFSCM’s experience in pre-qualifying vendors

 

PFSCM participated in the working group that collaborated with the committee to review and develop the WHO MQAS.

We gained vast experience in pre-qualifying vendors during the 10 years we managed the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) Supply Chain Management System (SCMS) project. During this period, PFSCM pre-qualified 57 manufacturers, 10 of which were based on the African continent.

PFSCM’s Quality Assurance unit operates under our stringent QMS, which is ISO 9001:2015 certified by one of the world’s most reputable certification bodies for management systems, DQS Management Systems Solutions.

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