Lot Release Department (LR)
Is the department responsible for the process of reviewing each individual batch of biological products such as vaccines, plasma –derived products and recombinant therapeutic proteins before giving approval for its release onto the market. This process provides NORCB with a real-time system to continuously monitor product quality, safety and efficacy. The release involves the review of manufacturer’s production data and quality control test results by the national regulatory authority, and may or may not include laboratory testing by the national control laboratory, or by an agency or contracted laboratory performing tests for the NRA.
Lot release was especially important for high risk biological products such as vaccines. for vaccines if strength of active components in a lot is sub-optimal, impact of using such a sub-optimal lot will not be known for a very long period (years), because benefits from vaccination not visible immediately. Similarly if there are safety issues with a particular lot, the impact will be devastating as a large no of healthy normal populations receive it.
The reliability of the lot release process was vital to ensure that poor quality / unsafe lots were detected and to avoid appropriate rejection of good quality product and disruption of supply.
- Receiving all biological products for evaluation of documents and testing by all relevant NCLs.
- Verifying all NCL testing results and summary protocol evaluation.
- Trend analysis evaluation for manufacturer results before the release of batches.
- Establish policies that organize lot release process to guarantee the availability of biological products in the Egyptian market at a reasonable time frame.
- Solving all problems and obstacles that occur throughout the time frame of products evaluation.
- Risk benefits analysis to take the decision for release of batches into the market.
- Issuing batch release certificates and notice of non-compliance.
Blood products (Albumins , Immunoglobulins , Factor VIII…)
Products made by recombinant DNA technology ( Insulins , Monoclonal antibodies ,…)
Lot release department has a quality management system certified by TUV according to ISO 9001/2015 that responsible for establishing the following regulations:
- Lot release policy for vaccines.
- Lot release policy for blood products.
- Lot release policy for recombinant products.
- Standard operating procedure (SOP) for release in case of emergency.
- Standard operating procedure (SOP) for risk benefit analysis.
- Standard operating procedure (SOP) for trend analysis evaluation.
The submitted product batch folder should contain the following documents:
- CAPA request form for sample analysis.
- Cold chain assurance report from CAPA.
- Batch release certificate from the National Regulatory Authority (NRA) of the country of origin for the imported products.
- Manufacturer certificate of analysis for the finished product.
- Manufacturer certificate of analysis for the solvent (if present).
- Complete summary protocol for each batch according to the international guidelines (for of vaccines and plasma derivatives only)
- Plasma release certificate from the National Regulatory Authority (NRA) of the country of origin for the imported products (for plasma derivatives only).
- n case that human albumin is used as a stabilizer, the company is committed to provide the following additional documents:
- Human albumin batch release certificate from NRA of country of origin.
- The document that proves the use of the same human albumin batch for which a release certificate is submitted in the manufacture of the final product of the batch in release request.
- The sufficient number of samples required for testing to ensure product quality, safety and efficacy.
- Reference material and other testing requirements.
Our Creative Team
Ch/Shaimaa Hamdy Shaded
Ch/Radwa Abd Ellah
Bacterial Vaccine deputy Safety monitor & evaluator
Viral Vaccine deputy
Blood & Extractable products deputy
Ph/Mostafa Abdel Moniem