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Table 2 Current Surveillance Practices and Quality Control Trends

From: Global landscape assessment of screening technologies for medicine quality assurance: stakeholder perceptions and practices from ten countries

Region

Government Regulator

Quality Control (QC) Trends

Surveillance Practices

Africa

Nigeria

▪ Nigeria – NAFDAC

▪ Preliminary screening, spot checks, and audits are conducted after products are imported, registered, and placed in market circulation.

▪ SF medicines detected: antimalarials and paracetamol are often found to be falsified.

▪ NAFDAC quality control laboratories support surveillance functions; local pharmaceutical companies, distributors and pharmacies ensure medicines are procured from trusted sources and perform occasional supplier spot checks.

Zimbabwe

▪ Zimbabwe – MCAZ

▪ Manufacturers perform visual check of packaging only after products are released to the market.

▪ Interviewees noted difficulties sharing WHO alerts about poor quality medicines with other Southern African Development Community countries.

▪ MCAZ must purchase samples for analysis.

▪ MCAZ receives alerts, holds suspect product, and contacts the manufacturer, suppliers, and wholesalers; alerts pharmacies as to specific batch numbers.

Americas

Argentina

▪ Argentina – ANMAT

▪ Distributors and pharmacies rely on the National Traceability System for assuring product quality and deterring SF medical products.

▪ Some manufacturers request that quality control laboratories test their starting materials and finished products.

▪ A manufacturer performs packaging inspections via microscope and infrared to determine the authenticity of suspect products.

▪ ANMAT inspectors collect drug product samples at private and public hospital pharmacies, distributors, wholesalers, drug stores, and customs; and conduct inspections at manufacturers.

▪ The Traceability Resolution mandates, a national system for integrated, unique identifiers of specific medicines.

▪ Raw materials and finished products are bar coded, but PMS is not done on products after they are sent to a distributora.

▪ A manufacturer uses a two-dimensional data matrix system and product serial numbers to track batches to the wholesale supplier and pharmacy.

Mexico

▪ Mexico – COFEPRIS

▪ A lack of standard quality control equipment and a high volume of analysis are major challenges for laboratories.

▪ COFEPRIS’s OMCL analyzes manufacturer-produced raw materials and finished products classified as controlled medicines; and authorizes destructionof poor quality products.

▪ The monitoring division of the COFEPRIS sends inspectors to manufacturers, distributors, and point-of-sale drug stores to monitor their compliance with quality regulations.

▪ An operations division carries out enforcement actions related to non-conforming medicine samples.

United States of America

▪ USA – FDA

▪ Multinational drug manufacturers use detection technologies (e.g., handheld spectrometers) at their plants to identify counterfeit raw materials.

▪ Ion Mobility Spectrometers are used for screening dietary supplements; Counterfeit Detection Device Version 3 for suspect products.

▪ FDA performs surveillance and targeted testing of samples for product and package evaluation at importation locations and FDA laboratories.

▪ The Drug Enforcement Agency and Customs and Border Protection carry out screening activities on medicines and health products.

Eastern mediterranean

Egypt

▪ Egypt – NODCAR

▪ Active pharmaceutical ingredients are imported and are verified prior to production; excipients are not verified but rely on internal vendor qualification proceduresb.

▪ Pharmacies purchase products from trusted registered distributors and wholesalers.

▪ PMS focuses on medicine storage and stability.

▪ NODCAR conducts visual inspection of packaging in random market sampling; suspect products are sent for laboratory testing.

▪ The Directorate for Quality inspects imported products; samples are sent to quality control laboratories for testing.

Jordan

▪ Jordan – JFDA

▪ Lack of human, instrumental, and financial resources are major challenges for the JFDA laboratory.

▪ A manufacturer uses bar codes on packaging as the only PMS and security checks of its products on the market.

▪ JFDA leads PMS activities and performs sampling and analysis at a single quality control laboratory.

▪ Medicines deemed suspicious by customs are quarantined until JFDA laboratory test results confirm product quality.

Southeast Asia

India

▪ State FDAs

▪ State FDAs noted the following challenges:

▪ Acquiring reference standards and analyzing samples quickly.

▪ Acquiring, maintaining, and funding recurring costs associated with laboratory equipment.

▪ A manufacturer noted:

▪ Performing periodic tests on random samples from its warehouse.

▪ Monitoring temperatures for proper transportation and storage conditions throughout the supply chain.

▪ Using tamper-resistant seals, barcodes, and pharmaceutical codes on its products.

▪ Pharmacies noted:

▪ Using no STs to monitor shelved products.

▪ Using online inventory, bar code scanning, and checking tablet codes for product quality.

▪ Obtaining products from manufacturer to avoid SF products.

▪ Relying on local Food and Drug Control laboratory for testing products that receive complaints.

▪ State FDAs have primary responsibility for screening activities.

▪ Inspectors sample medicines from sites (e.g., retailers, wholesalers, hospitals, clinics) at various geographic locations.

▪ Each quarter, certain classes of medicines are earmarked for screening. Samples are tested for identity, potency, and disintegration; results trigger enforcement action.

▪ Some state FDAs use a public portal as part of its e-Governance platforms for pharmacovigilance, SF notices, and recalls.

▪ A pharmaceutical company with well-equipped laboratories performs PMS on its products prior to release to market.

Western Pacific

Philippines

▪ Philippines FDA

▪ Philippines FDA laboratory in Alabang typically performs quality control testing.

▪ Manufacturers in the Philippines do not perform PMS on their products.

▪ Equipment for testing products within the supply chain is lacking; however, visual inspection of packaging is performedc.

▪ Philippines FDA conducts surveillance and screening activities.

▪ Field inspectors visit and collect samples from drug stores, pharmacies, and distributors.

▪ FDA laboratory conducts compliance testing of medicines received by the Department of Health central warehouse from suppliers.

China

▪ The National Institutes for Food and Drug Control (NIFDC)

▪ Sample products are submitted to the China Food and Drug Administration to ensure adherence to current good manufacturing practices and guidelines from the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, according to a manufacturer.

▪ Pharmacies noted that pharmaceutical products are:

▪ Obtained from qualified suppliers

▪ Visually inspected and batch numbers checked for product quality

▪ Stored under recommended conditions;

▪ Consumers can check products for the manufacturer name, batch number, and China Food and Drug Administration certification number.

▪ NIFDC performs annual quality assurance including random checks of medicines and other medical products.

▪ Local NIFDC performs city-level PMS and checks for SF medicines by sampling products from rural hospitals and drug stores.

▪ Essential medicines obtained from the market are tested in mobile vans with instruments that can be linked to a laptop for data transfer.

▪ Manufacturers lack the resources or capability to carry out routine PMSd. Most SF products found at the pharmacy are damaged products, which are sent back to the suppliers and if this happens “too often” the supplier is changed.

  1. aAccording to a manufacturer
  2. bAccording to a manufacturer interviewed
  3. cAccording to a DOH provincial hospital pharmacy
  4. dAccording to a manufacturer interviewee