Quality Control
Our in-house state-of-the-art testing laboratory is fully equipped with the latest pharmaceutical lab apparatus. We have a highly qualified and experienced technical team, who use transparent, traceable and calibrated techniques to maintain high standards of quality at all stages of the manufacturing and delivery process.
Our quality control (QC) laboratory plays a critical role in pharmaceutical production, for both in-process and finished product testing. We at Halewood not only monitor and control the quality of incoming APIs (active pharmaceutical ingredients), but other supplies used in the manufacturing process; QC Labs are also instrumental in the batch release process.
We operate in total compliance with the GMP norms set by the WHO (World Health Organization) and the latest international guidelines set by the USFDA/ UKMHRA/ EUGMP. These norms are adhered by our laboratories listed below:
Chemical Laboratory: Has a highly-qualified technical team and well-laid out Standard Operating Procedures (SOPs) for operations.
Instrumentation Laboratory: The fully equipped QC department has the latest lab equipment, such as HPLCs, UVs, TOC, Walk in Stability Chambers & Incubators among other instruments.
Microbiology Laboratory: We have a dedicated Microbiology laboratory designed as per ISO 7 norms to ensure cleanliness and adherence to international standards.
The products are subjected to a series of microbial tests during production and post production. The environment and utilities are continuously monitored on a real-time basis here.
Quality Assurance
Our Quality Assurance (QA) Department adheres to strict operating procedures by maintaining the highest standards of safety and quality.
Our QA team follows clear and precise working instructions for each process activities and operations of equipment by adhering to the Standard Operating Procedures (SOPs) that are written and reviewed by technically qualified personnel. Approved SOPs are available for all critical activities carried out at our manufacturing facility. Implementation and compliance are the responsibilities of individual department heads and Quality Assurance Department.
A team of Trained Quality Assurance Chemists under the supervision of Senior Quality Assurance Chemists and the overall direction of the Head of Quality Assurance carries out these activities. Specification and Analytical test methods for Raw Materials, Packaging Components, In-Process and Finished Products are written by Qualified Personnel (Chemists).
Sampling of Raw Materials, In-Process, Bulk and Finished products are performed by the qualified and trained personnel from QA department.
Control at all stages of the manufacturing and packaging processes is maintained by the Quality Assurance Department through strict enforcement of cGMP’s standards. Similarly, all equipment and system qualification and validation are designed and reviewed by suitably trained and qualified personnel before the final approval by Quality Assurance Head.
All Procedures, Protocols and Reports must be approved, signed, and dated by our Quality Assurance Head.
Stability Studies & Documentation
We at Halewood Lab, have installed huge Walk in Stability Chambers along with other Stability chambers for conducting stability studies of the products by determining the stability of our products at different temperature and humidity conditions.
We have a seasoned Regulatory Department with qualified & experienced personnel who prepare dossiers as per the guidelines of the Ministry of Health of different countries and its regulatory bodies.