Quality control laboratories
Objectives
The objective is to ensure the accreditation and functioning of QC Laboratories in line with National, Regional and International standards for NMRAs handling the regulation of medicines in ECOWAS member states. This will include;
- Having a common QCL manual based on regional and international recognized standards developed and adopted by NMRAs’ in the ECOWAS member states e.g. WHO, ICH Guidelines, ISO and WAHO guidelines.
- QCL policies and manuals in each of the West African member states NMRAs implemented to ensure efficiency and transparency in the provision of regulatory services by the NMRs in the region
Documented Information on Quality Control Laboratory
Quality Control Laboratory: is a laboratory providing testing services that generates analytical data within a quality system framework to provide clients with an accurate and representative portrayal of a sample's constituents, enabling them to meet their regulatory and monitoring commitments. This includes medical diagnostic laboratories.
Purpose of Guideline
The purpose of this guideline is to strengthen systems for effective Post Marketing Surveillance of medicines, and regulated products including medical devices to ensure that only quality and safe medicines and other regulated products are distributed throughout the West African sub-region. Effective implementation of PMS Guidelines will enable NMRAs generate scientific evidence on the quality and safety of medicines and medical devices for improved health outcome. It is important that WAHO sustains a high quality and scientifically credible safety and efficacy data on these vital health commodities to enhance evidence based decision making that impacts public health.
Scope
The plan is designed to cover a wide range of medicines and regulated products marketed in West African sub-region in order to strengthen and improve their quality and safety. Ensuring that there is adequate funding is vital during the PMS planning.In a situation where resources are limited, the PMS program can focus on medicines and parameters that pose higher risk to patients by applying risk analysis during the planning phase.Collaboration with relevant partners and sharing of resources including testing capacities, experiences and information can enhance the effectiveness of PMS program.
SOPs
Setting up of a Regional Post-market Surveillance Strategy for the Quality of Medicines
Good Documentation Practices
Purpose
This procedure describes the activities to be carried out on relevant administrative processes to address the organization, management and control of data and information saved or being accessed on electronic or manual systems to ensure data integrity.
Scope
This procedure applies to all manual and electronic data and metadata generated in the laboratory.
Procedures:
Data and Information Policy:
All laboratory data and information must be stored, managed and control in such a way as to guaranty retention of its integrity in a secure manner that will ensure only authorised personnel have access at assigned level.
Data and Information Back-ups:
- All data on computers not attached to the server should be backed up into designated external drive at the end of every week.
- The external drive is immediately backed up on the server.
- All data and information residing in the server should be backed up on a weekly basis into a designated external hard drive precisely at the end of working hour of the week.
- The backed-up information should be transferred into the cloud account created for the laboratory.
- Retrieval can be done only by designated officers approved by the Head of Laboratory.
- The device should not be taken out of the approved storage area without prior written approval from the QA Manager and the HOL
Inter-laboratories Proficiency Test Management
Inter-laboratory Comparison (ILC): Organization, performance and evaluation of tests on the same or similar item by two or more laboratories in accordance with predetermined conditions.Purpose
This procedure describes the activities to be carried out on relevant administrative processes to address the organization, management and control of data and information saved or being accessed on electronic or manual systems to ensure data integrity.
Scope
This procedure applies to all manual and electronic data and metadata generated in the laboratory.
Procedures:
Registration
- The Head of Units of testing laboratory shall in consultation with the Head of Quality Assurance plan and register to participate in a PT /ILC scheme each year from a recognized service provider.
- Laboratories with 4 or less sub-disciplines on their scope are required to participate in at least one proficiency testing activity per year.
- Laboratories shall have a documented plan of how they intend to cover the applicable program requirements or the major sub-disciplines and materials/matrices/product types on their scope of accreditation over a four-year period. This plan shall cover any commercially available participation and any inter-laboratory organized studies, as applicable.
- The laboratory shall ensure to participate in relevant and commercially available proficiency testing at a frequency sufficient to ensure that all sub-disciplines and materials/matrices/product types on the scope(s) of accreditation are covered over a four-year period.
- All PT/ILC samples shall be received and registered in the Proficiency Testing Sample Register by the Quality Assurance Unit.
- There should be registration code for all samples
- Laboratories shall conduct proficiency tests in accordance with their normal testing and reporting procedures, unless otherwise specified in the instructions from the Proficiency Test Provider.
- Laboratories shall ensure that Proficiency Testing Sample (PTS) are equally distributed among trained and qualified personnel for the relevant tests.
