A well-functioning government drug control laboratory forms an important regulatory element of any QA system because it carries out the tests and assays required to establish whether drugs conform to the specifications claimed. In countries where such a laboratory exists, the NTP manager or his/her staff should take the lead in sending drug samples for quality testing. Samples of FDCs should be tested using accepted/adopted pharmacopoeial methods and techniques. Pharmacopoeial procedures usually involve:
• testing for uniformity of dosage units in terms of weight for tablets and volume for ampoules/vials;
• identification of active pharmaceutical ingredients (API) (for 4-drug FDCs: rifampicin, isoniazid, pyrazinamide, ethambutol);
• a dissolution test;
• assay for the content of each active ingredient.
The United States Pharmacopeia and National Formulary (USP 25/NF 20) has recently released test methods and procedures for the 4-drug FDC preparations containing rifampicin, isoniazid, pyrazinamide and ethambutol.
After each analytical testing, the laboratory issues a certificate of analysis indicating the quality of the FDC tested based on the test results. The certificate should state clearly whether or not the FDC sample tested is in compliance with the required specifications.