Quality
‘Quality’ is one of the core philosophies of ‘Business’ at HLL Biotech. Ltd. (HBL)
Our Basis for achieving Quality
HBL management vision is to drive and build its quality team to ensure that each and every vial of vaccine product/s manufactured and distributed are of consistent high quality and complies with all internationally accepted good practices and standards of quality, purity, efficacy and safety.
Towards this objective of quality, the quality department are in the phase of developing systems to advocate quality through continuous improvement in all activities by ongoing development work, by defining quality policy & strategy, training of personnel and relevant standard operational procedures for manufacturing of vaccines and meeting the quality standards.
HBL remain committed to the highest levels of quality and will ensure that all our facilities, offices and legal entities continue to meet the exemplary standards that are expected of a global vaccine company.
Infrastructure Support
The Quality control and Quality Assurance sections at IVC are distinctly constructed in a separate block, away from the production facility and connected through spine.
The QC labs are independent and designed appropriately for operations to cater all the requirements of analytical support required for IVC product mix of vaccine/s. concerned with sampling, storage, testing, and documentation and release procedures covering raw materials, package components, in-process materials, labelling and finished products. To handle the operations QC has further following laboratories/ areas:
Media Preparation and Washing Area
Microbiology Lab/s
Virology Lab/s
Cell culture Lab/s
Sterility Lab/s
Chemistry/Biochemistry Lab
Immunochemistry Lab
Instrumentation Lab
RM/Packing material Lab
Retention/ Control Sample Storage Area/s
Stability area
Vivarium (Animal House) – The biological nature of vaccines necessitates that each batch is evaluated for its safety and efficacy. The Vivarium at HBL is a state-of-art standalone independent facility encompassing both breeding and testing on laboratory animals. The facility is designed as per CPCSEA norms and will cater to both the quality evaluation of commercial vaccine batches and process optimization / R&D activities. All the protocols will be taken for in-vivo evaluation only after the approval of IAEC committee.
Apart from core quality testing laboratories, a dedicated mycoplasma lab is designed to cater the testing requirement/s.
These labs are supported by on-campus utility systems and services for power, water, HVAC and gases.