Documents to be submitted
Submission of an application for evaluation for prequalification of a quality control laboratory (QCL) involves preparation and submission of the:
- covering letter expressing interest in participating in the prequaliﬁcation procedure
- laboratory information file (LIF) including details of services offered, as well as those proposed for prequalification, or the laboratory’s quality manual if this contains all the information that would be included in a Laboratory Information File.
All of the information should be submitted in English. Submissions that are not made in English must be accompanied by a certified English translation.
Preparation and presentation of laboratory information
The information that should be included in the LIF is described in the relevant WHO guidelines.
Alternatively, if the laboratory has documented its quality system as a quality manual, this can be submitted instead of an LIF, provided that it is supplemented with any information required for the LIF, but not included in the quality manual.
The information that be included in the LIF is as follows:
- the laboratory, including the activities proposed for prequaliﬁcation
- the quality management system implemented by the QCL
- inspections and external audits performed at the QCL
- the QCL’s participation in proﬁciency testing schemes and/or collaborative trials
- internal audits
- control of documentation and records
- reagents, reference substances and reference materials
- subcontracting of testing (where applicable)
- handling of samples
- validation of analytical procedures
- investigation of out-of-speciﬁcation results;
- stability testing (where applicable)
- microbiological testing (where applicable).
Screening of submitted laboratory information
The information submitted by the laboratory will be screened for completeness. Incomplete information cannot be considered for evaluation.
Where to send an application for product evaluation of an API and responses to requests for further information
An application for evaluation for QCL prequalification and subsequent responses to questions raised by WHO assessors should be sent to:
World Health Organization
WHO Prequalification Team: technical assistance and laboratories
HIS/EMP/RHT/PQT Room 613
20, Avenue Appia
1211 Geneva 27