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Why Choose Medicines Quality Control and Surveillance Department

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:

ISO/IEC 17025 Accredited Testing Scope

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


Sample Submission

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


  1. Sample Submission Guidelines
  2. Request for Analysis Form
  3. Sample Submission Form

You may also contact the MQCSD directly for further information at carphajam@carpha.org

 

Customer Service and Performance Standards: Turnaround Times

Request for Analysis

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.


Analysis of Samples

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.



Customer Feedback and Complaints

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.