It is a specialized directorate responsible for Lot Release function and quality control of vaccines, biological products, and medical devices to ensure safety, quality, and efficacy
Quality control ensures these products meet safety, quality and efficacy standards before public use
Vaccines are biological preparations that stimulate the body’s immune system to protect against specific infectious diseases
Biological products are medicines derived from living organisms, such as vaccines, blood products, antibodies, insulin, and gene therapies
Medical devices are instruments, apparatus, appliances, materials, reagents, or other articles including software intended by the manufacturer to be used for the diagnosis, prevention, monitoring, treatment, or alleviation of diseases or injury, investigation or replacement of anatomy, or control of conception
They are medical Devices, whether used alone or in combination, intended by the manufacturer for the invitro examination of specimen derived from the human body solely or principally to provide information for diagnostic, monitoring, or compatibility purpose
It is the regulatory process of independently evaluating an individual batch or lot of a licensed vaccine to ensure its safety, potency, and quality before it is distributed to the public.
Document review: The review of the manufacturer’s Summary Lot Protocol, which details all production steps, quality control test results, and ingredient specifications for that specific batch.
Independent testing: Tests is carried out on samples from the batch to confirm its identity, potency and efficacy.
Certificate of Lot Release: Issued to every satisfactory lot of product tested.
Summary Lot Protocol
Vaccine Arrival Report
Certificate of Analysis
Temperature excursion Report
Packing List
Certificate of Release from country of origin.
It is an official form issued to the customer to document and specify the precise test parameters being requested for analysis.
The timeline for analysis is 60 working days.
Yes, samples can be rejected.
Samples will be rejected based on the following conditions:
- Compromised cold chain system during transport or delivery.
- Submission of insufficient sample quantities (failing to meet the approved sample guide).
- Non-availability of required documentation.
- Poor or illegible labelling on the products.
- Disparities between the product information and the provided documentation.
- Products with less than six (6) months of remaining shelf life from the expiry date (unless it is a specialty product natively designed with a very short shelf life).
No.
Samples are submitted through technical directorates based on the regulatory requirement for the product (Registration, Compliance or investigation) with a memo signed by the Director or a designate.
Yes.
No.
The samples are received at the Director-General’s Office and sent to the Laboratory with a memo signed by the DG.
Enquiries are made at the Liaison office of the Director.
No, the result of analysis for your samples are submitted to the directorate that submitted the samples for analysis.
