Controlling the quality of drugs before and after a marketing authorization has been issued is critical for ensuring the quality and safety of drugs. The DRA must therefore have access to a QC laboratory. Indeed, the capacity of a national DRA to undertake quality surveillance is directly related to the operational capability of the QC laboratory. The results of a laboratory assessment of samples of marketed drugs permit the regulatory authority to evaluate the actual quality of products used in the country and to identify problems pertaining to drug quality. In doing so, it minimizes the amount of sub-standard drugs and raw materials in circulation. In general, even a small, simple laboratory may be a sufficient deterrent against unscrupulous or negligent manufacturing and trading practices. It may also encourage improvements in the standard of local manufacture, since manufacturers may be encouraged to upgrade their production sites, for example, by the prospect of an independent assessment of the quality of their products.

This section compares the structures and functions of QC laboratories in the 10 countries.

10.1.1. Quality control capability

The requirement for drug analysis by the government or an independent laboratory is an integral part of the legal provisions of drug regulation in all 10 countries. In each of the countries, the government has established laboratory facilities to perform this function. Most countries have organized a QC laboratory within the DRA. In a few countries, the organizational arrangement is slightly different. Cyprus has two QC laboratories: the General Laboratory is an agency outside the DRA, but which operates under the Ministry of Health, and the Pharmaceutical Laboratory comes under Pharmaceutical Services, which constitutes the DRA. Each of these laboratories performs testing for drug regulation, as well as undertaking analysis for other purposes. The Ugandan NDA, in collaboration with the Department of Pharmacy of Makerere University, uses the laboratory facilities at the university to carry out QC testing, although it has plans to build its own laboratory.

All the laboratories carrying out QC of drugs have the capacity to perform physicochemical testing. Those in Australia, Cuba, Cyprus, the Netherlands and Venezuela are also equipped for testing biological products. In Cyprus, however, the biological products tested are mainly human plasma derivatives and insulin products. Drug regulatory authorities in some countries also make use of external facilities to perform testing for regulation purposes. However, no countries contract out their QC functions to other institutions. Table 10.1 summarizes the key structural features of drug control capacity in these 10 countries.

Table 10.1 Features of the quality control laboratories

• = Yes = No - = data or information not available.

* Official Medicines Control Laboratories (OMCL) survey, collaborative assays on behalf of WHO, International Organization for Standardization (ISO), etc., to set standards.

** General Lab. and Pharma. Lab. participate in proficiency-testing studies and market surveillance studies organised by European Department for Quality of Medicines for Official Medicines Control Laboratories

*** European Network of Official Medicines Control Laboratories.

**** ASEAN Regional Training Centre for QCL and WHO Collaborating Centre in the Regulatory Control of Pharmaceuticals.

***** INHRR laboratories are Centres for International Reference on Biological Products, diagnosis kits for Andean area, and are part of the network of quality labs for Pan- American Sanitary Office (OPS) coordinated by the USP. They also participate in OMCL survey.

To be able to perform their tasks effectively, QC facilities must have enough qualified personnel and the necessary equipment and materials, and operate according to established standards.

As indicated in Table 10.1, all the laboratories have access to a variety of pharmacopoeia, and usually the latest editions. The laboratories in the majority of countries follow SOPs and guidelines. Reference standards are available in all the countries, albeit at varying levels. Small laboratories sometimes have difficulty acquiring enough, and the right type, of reference standards to perform the required analysis. With the exception of Estonia and Uganda, laboratories in all the countries prepare their own working standards for drug analysis.

10.1.2 Multiple functions of QC laboratories

Most QC laboratories working for the drug regulatory authorities carry out functions in addition to laboratory analysis (Table 10.2). First and foremost, they all participate in drug analysis for registration purposes. Some of them also analyse samples submitted for post-marketing surveillance. A number of these laboratories also perform tests on other products, such as medical devices, condoms and drinking water. Personnel from the QC laboratories in Australia, Malaysia, Venezuela and Zimbabwe take part in inspecting the QC laboratories of the pharmaceutical industry. This helps to improve the industry’s ability to perform QC, eventually leading to better-quality drugs on the market. Most laboratories also conduct research and train analysts. The drug control laboratories of Australia, Malaysia, Tunisia and Zimbabwe provide training for both local and international analysts.

10.1.3 Post-marketing surveillance

In addition to testing for pre-marketing QC, the DRA laboratories in Australia, Cuba, Cyprus, Malaysia, Venezuela and Zimbabwe also collect drug samples for testing as part of post-marketing quality surveillance. Post-marketing surveillance is conducted differently in each country. Planned sampling is carried out in Australia, Cyprus, Estonia, Malaysia and Venezuela. In Australia, sampling is targeted on complementary medicines and non-prescription drugs, while in Malaysia all types of products are sampled. In Cyprus, the emphasis is on products containing sensitive substances, products used for serious diseases and generic products posing interchangeability problems. Quality surveillance in Cuba focuses on samples collected from manufacturers in connection with GMP inspection, rather than on samples collected from the “market”, i.e. retailers.

Table 10.2 Functions of QC laboratories

• = Yes = No N/A = not applicable