Standard Operating Procedures
Procedures set out in the standard operating procedures (SOPs) are followed by the IMD-PQS Secretariat, the IMD-PQS Working Group and by all technical specialists commissioned by the Secretariat. They are a useful source of information for manufacturers seeking prequalification of an immunization product since they describe and illustrate with examples the steps of a procedure, making it transparent for all stakeholders. They also indicate key responsibilities among those implementing the procedures.
SOP 009 How to evaluate applications for product prequalification
IMD-TP-09a Standard letter A - Invitation to apply for prequalification
IMD-TP-09b Standard letter B - Prequalification information pack
IMD-TP-09c Standard letter C - Request for missing information
IMD-TP-09d Standard letter D - Evaluation notification
IMD-TP-09e Standard letter E - Rejection
IMD-TP-09f Standard letter F - Acceptance
SOP 010 How to re-evaluate an IMD-PQS prequalified product
UPDATED VERSION COMING SOON
SOP 011 How to remove a prequalified product from the IMD-PQS database
UPDATED VERSION COMING SOON
SOP 012 How to field test an IMD-PQS product
UPDATED VERSION COMING SOON
SOP 013 How to obtain feedback on the performance of an IMD-PQS product
UPDATED VERSION COMING SOON
SOP 14 How to audit a laboratory for IMD-PQS accreditation
UPDATED VERSION COMING SOON