Standard Operating Procedures

Procedures set out in the standard operating procedures (SOPs) are followed by the PQS Secretariat, the 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.

Current SOPs are as follows:

SOP 001: How to develop and publish a PQS product performance specification (1 April 2020)

SOP 002: How to review and revise a PQS product performance specification (1 April 2020)

SOP 003: How to withdraw a PQS product performance specification (1 April 2020)

SOP 004: How to develop and publish a a PQS product verification protocol (1 April 2020)

SOP 005: How to review and revise a PQS product verification protocol (1 April 2020)

SOP 006: How to withdraw a PQS product verification protocol (1 April 2020)

SOP 007: How to assess a laboratory for PQS accreditation (1 April 2020)

SOP 008: How to re-evaluate a WHO PQS-accredited test laboratory (1 April 2020)

SOP 009: How to evaluate applications for product prequalification (1 April 2020)

SOP 010: How to re-evaluate a prequalified PQS product (1 April 2020)

SOP 011: How to remove a prequalified product from the PQS database (1 April2020)

SOP 012: How to field test a PQS product (1 April 2020)

SOP 013: How to obtain feedback on the performance of a PQS product (1 April 2020)

SOP 14: How to audit a laboratory for PQS accreditation (1 April 2020)