The stipulated time for analysis of Vaccines/biologicals is 8 weeks (working days only)
CONDITIONS FOR REJECTION OF PRODUCTS
- Products with compromised cold chain system
- Submission of insufficient products as per sample guide
- Non-availability of required documents
- Poor Labelling of products
- Disparity in product information and required documents information.
- Products with shelf life less than six (6) months from expiry date (except for products with short shelf life).
All enquiries concerning sample submitted for analysis is made at the Directorate sample was submitted, which can then be forwarded to the Director or office of the Head of Laboratory.
The Head of Laboratory receives all complaints and ensures the resolution of all complainants related to laboratory activity. Complaints should be resolved within 45 working days.
Documents submitted during sampling of vaccines are
- Certificate of Analysis (COA)
- Certificate of Release (COR) from NRA of country of Origin (Vaccine)
- Summary Lot Protocol for production and testing (vaccines).
TRF stands for Test Request Form. It is a form issued to the customer to documents samples submitted to the laboratory and also to indicate test parameters being requested for the sample submitted by customers.
Vaccines should be stored and transported to the laboratory as stipulated on the product label by the manufacturer.
No, except when there are issues of controversy after going through the appropriate channel.
In the event an issued laboratory report needs to be changed, amended, or re-Issued, amendments to a laboratory report after issue shall be made only in the form of a further document and changes will be defined and shall be clearly identified.
The laboratory ensures customer satisfaction by analysis of samples as per stipulated timeline, Prompt handling of complaint, Continuous seeking and analysis of feedback (both positive and negative) feedback from customers and continuous communication of customers’ requirements to personnel of the laboratory.
When content of documents submitted are insufficient and the lab is awaiting response for more documents to be submitted by company.
Based on the approved sampling guide.
Laboratory Risk-Based Testing & Categorization.
