RHYDBURG has been known for its supreme quality and product stability. It has a dedicated team to ensure that the drugs are manufactured in strong compliance to the WHO-cGMP standards. Maintenance of SOPs, process validation, upgrading analytical procedures, monitoring protocols, sampling surveillance and master formulae maintenance is carried out by the team headed under the guidance of eminent professionals both from with-in the highly qualified staff at the unit and other organizations comprising of consultancy firms and quality management systems providers. Involvement of educational institutions and researchers has also proven to be beneficial in the quality process of the company.
The site is away from open drainage and sewages and is free from environmental pollution. It is perfectly maintained to avoid entry of insects, pests, birds, vermin & rodents inside the manufacturing premises. Hence, the environment of the firm is absolutely free from all type of contamination. No toxic or hazardous substances are processed or evolved during the process. A separate ETP (Effluent Treatment Plant) is present at the unit to take care of the waste disposal and to prevent harm to the environment. All the activities carried at the unit are under constant vigilance of highly qualified personnel and are followed according to the SOPs.
Sixteen separate Air Handling Units (AHU) are provided for the production area of Tablets, Capsules, Ointments, Liquid orals and Q.C. Lab. The air handling systems have been provided with the pressure balancing arrangement to eliminate any possible cross contamination of the products. Along with this an online de-humidification system is provided for the Capsule section. The site has a centralized utilities section with Boiler, Generators & Compressed air system, which is located on the top floor. AHUs and Air washers are placed on the service floor.
All the Critical Areas have been provided with Class–100000 systems to control contamination. They have .3 micron filters in place to prevent any kindd of contamination. Similarly, sterile room of Q.C. Lab has been provided Class-10000. 5 micron filtered air has been provided in all secondary packing and all corridor.
Specifications and Standard Testing Procedures are prepared by Quality Control and finally reviewed and issued by Quality Assurance department. In case of regulatory specifications and testing protocols external agencies are consulted. Specifications and STP are written in prescribed format with identification no., effective date and approval signatures. These are updated if there is any change in regulatory requirements or pharmacopoeias or change in specifications, by the completely automated document management system that integrates the complete unit. All documentation changes are made prior to the applicability and physical effect of the action is observed.
Quality control & assurance are both supervised by approved and experienced staff directly reporting to the management but independent of the other departments. It controls all the incoming raw materials, packing materials, in-process manufacturing and stability of finished products. It has complete authority to review the production to assure that no errors have occurred. Apart from the quality control and quality assurance team, a specialized and independently functioning team of quality management is operational headed by the technical director in close consultation with the Managing Director which constantly gazes the entire processes and activities carried out in the premises. Audit and approval of vendors and contract manufacturers, evaluating and analyzing market complaints and batch recalls, if any, are investigated by the quality team and have been nullified to negligible in the past years.