Medicine quality, efficacy and safety are critical to Ministries of Health, national medicines regulatory authorities/procurement bodies, manufacturers, distributors, healthcare professionals and consumers. Confirmation of the good quality of a medicine by competent and accredited laboratories is an international regulatory requirement. Our Department provides the following benefits:
Confirmation of Medicine Quality: Minimised risk of producing or supplying a substandard/ falsified medicine
Reduce Testing Costs: Avoidance of retesting by another laboratory to confirm medicine quality
Global Acceptance of Test Results: Certificates of analysis are more readily accepted worldwide
Chemical/ Physicochemical Analysis of Finished Pharmaceutical Products for the United States Pharmacopeia and British Pharmacopoeia
High Performance Liquid Chromatography(HPLC)
UltravioletVisible Spectroscopy (UV/Vis)
Dissolution
Disintegration
pH
Uniformity of Weight
Fourier-Transform Infrared Spectrophotometry
The Department also offers Non-accredited Chemical / Physicochemical Testing
Loss on drying
Water / Moisture Content
Thin Layer Chromatography
Potentiometric and Volumetric Titration
Specific Gravity/Weight per mL
Samples are submitted to the MQCSD by CARPHA Member States by the responsible focal points in national medicines regulatory authorities/ procurement bodies. Further guidance is available here:
MQCSD Documents for Submission of Samples for Testing
You may also contact the MQCSD directly for further information at carphajam@carpha.org
A technical review of customer's requests for analysis is performed to determine the Department's capability (facilities, instruments and equipment, reference standards, reagents and personnel expertise) to conduct testing. A response will be sent within five (5) business days of receipt of the Request for Analysis.
Certificates of Analysis will be issued for testing at request of a CARPHA Member State within 30 - 45 working days (time taken from receipt of the sample to issuance of a Certificate of Analysis). Certificates of Analysis for the Post Market Surveillance programme are issued within the programme’s testing schedule.
Customers can submit general feedback on the quality of testing service provided by MQCSD using the Customer Feedback Form. MQCSD also accepts feedback from clients by means such as email and telephone. Complaints are assessed by MQCSD to determine how they should be investigated and resolved. The customer is notified verbally and/or in writing on the investigation and resolution of the complaint. Corrective actions are decided on a case by case basis. If the complaint relates to out-of-specification test results, a re-examination of the relevant data and records shall be made. If the Head of MQCSD deems it necessary, re-testing is undertaken. If investigation of the complaint reveals a non-conformance in the Department's quality system, the corrective action process is initiated.
Copyright 2022 by The Caribbean Public Health Agency