Capsules:
Manufacturing is done under class 100,000 area with Brine Air technology for control of Humidity and have the capabilities to manufacture the capsules in powder form and in Pellet form. The operation is Automatic and has uni-flow direction of the materials.
External preparations:
Company is manufacturing various types of preparations for external use such as Ointments, Creams, Gel, Lotions, etc. The manufacturing is done in a complete enclosed manufacturing system and is totally automated at every step of manufacturing. The area is designed to make sterile preparations.
Parenteral Preparations including Eye and Ear drops:
Britannia Biological LLP is expanding its position in Parenteral with state-of-the-art facility in clean rooms application. Britannia Biological LLP has the most advanced manufacturing capabilities in Parenteral manufacturing the area ranges from class 100,000, class 10,000 to class 100 under LF spread over 25,000 sq ft. The production is divided into three grades according to the clean room class and is classified as ‘O’ Open Products Area, ‘E’ Closed Product Area and “F” Non Production Area. The machines are among the best in the industry and have huge capacity to manufacture quality products.
Manufacturing of Ampoules with Eight head automatic Ampoule filling machine and 16 head Dry powder filling machine both capable to manufacture 12,000 units per hour. The operation is online and has uni-flow direction for the movement of the materials.
Manufacturing of Ampoules, Liquid vials and dry powder injection in all sizes.
Long acting parenteral preparations, Sensitive products manufacturing, Aseptic filling, Terminal sterilization, Lyophilization and others.
Packing capability includes: Automatic visual checking machine for vials and Ampoules, Blistering of Ampoules, Online labeling and packing system.
At Britannia Biological LLP we have a high regards for Environment, Occupational Safety and health hazards, the company is entirely dedicated to this commitment. We not only meet the government’s norms but are surpassing such regulatory requirements.
PRODUCTION CAPACITY
Injectable Production Unit | Yearly Production Capacity |
Liquid Vials | 48 Million |
Ampoules | 120 Million |
Powder For Injections | 120 Million |
Lyophized products | 1.5 Million |
Productions Unit | Yearly Production Capacity |
Tablets | 480 Million |
Capsules | 12 Million |
Liquid Syrups | 12 Million |
Dry Syrups | 12 Million |
External Preparations | 12 Million |
Sachets | 24 Million |
Powders | 6 Million |
CRAMS – Custom Research And Manufacturing Services
Britannia Biological LLP offers the complete package; right from development of drug intermediate stages moving up to developing API’s and finally the formulation dosage forms, commercial manufacturing and packaging.
Our R&D team constantly strives towards cost reduction by adopting new methods, process simplification, standardization and technology upgradation.
An intelligent team of scientists, R&D and manufacturing chemists are committed to a policy of continuous product and process improvement for the benefit of the customers.
We offer services for :
- Process development of Pharma dosage forms, API’s & Drug intermediates.
- Formulation development in different dosage forms
- Synthesis route development and optimization.
- Impurities synthesis and identification.
- Developing environmentally friendly processes
- Technology transfer
- IPR
- Bio equivalence studies
- Stability studies
- Dossier compilation
- Private labeling
- Commercial manufacturing in large volumes
Regulatory
Right from its inception’s objective remained to provide drugs of the highest quality and purity for the common man that is zealously persuade till date. ‘Excellence in quality’ is a commitment and the entire staff is dedicated towards this common goal. The quality did not start but was there from the beginning of the unit when the FDA, India, granted the GMP certificate. The regulatory body in India has the most stringent laws comparable to any international body and is fairly similar to the US FDA. As a result, from the continued efforts to upgrade the existing facility and technology with much hard work, the company’s major achievement was when it was granted the WHO GMP certificate for 99 products. We proud our self to be among the best generic and branded generics companies in India for the quality product we produce.
The manufacturing process is being disposed off as per the industrial norms and guidelines. Strict compliance to the rules and regulations set forth by the pollution control board are being adhered to. Britannia Biological LLP looks for the stronger support of its people to adhere to cGMP requirements. Britannia Biological LLP is continuously upgrading its facility not only in quality but also its management & administration control.
Quality control
The company has self-sufficient laboratories inside all 4 plants in place and have some most dedicated personnel’s who are highly motivated to lead this organization. Apart from the Pharmacopoeia requirements the laboratory is equipped to conduct various tests that are required to make a quality product. Capability to identify the impurities and to study the degradation of the products helps to improve the product quality and improves the general understanding of the products.
Quality Assurance
Britannia Biological LLP has ever since strived to improve its existing facilities by carrying out regular inspection and updating of technology for its products and processes and thus adhere to cGMP. To ensure that the cGMP standards are met and products comply with international quality standards, quality control measures having been imbibed at various stages of productions-from approval of raw materials to goods in-process as well as monitoring of the manufacturing process and extends up-to checking of finished goods. Quality assurance in the production is adhered by strict in-process controls and by validation and optimization of the process to improve quality and production.
CAPA: Corrective and Preventive actions
The company has in place a complete written program under CAPA and the procedure is well defined
Britannia Biological LLP under CAPA is analyzing processes, work operations, quality audit reports, quality records, service records complaints, returned product and other sources of quality data to identify existing and potential causes of nonconforming product and other quality problems. Appropriate statistical methodology is employed where necessary to detect recurring quality problems.
Investigation is done for the cause of nonconformities relating to product, processes and the quality system.
Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems.
Verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished product.
Recording changes in methods and procedures needed to correct and prevent identified quality problems.
Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product for the prevention of such problems.
Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.
COMMITTED TO EXCELLENCE
reliable, safe and affordable
QUALITY
At Britannia Biological LLP we are deeply committed to excellence and quality. Our team is committed and works hard to deliver the best for the cause of life. The only way we can make our commitment of healthier and happier world come true is by providing better and even better quality of products.
If one were to seek out a single word that embodies the spirit of the company, It is apparent right from the moment you step into the premises, in the numerous facets ingrained and internalized into the company’s ethos.
The Company develops products that deliver value to customers, meet health needs of patients and improve their lives. In pursuit of this concern, Invision has substantially invested in becoming a technology-driven best pcd pharma companies in India.
Our patient-centric approach extends to our quality policy as well. Our focus on quality helps to ensure product safety and efficacy, regardless of the drug form. We believe that quality is the mainstay of competitiveness. We thus constantly create an environment of Quality and Compliance in line with the global best practices. Our dedication to quality in everything we do is uncompromising, and covers every stage of the development, production and marketing of our medicines.
Our commitment to implementing a robust global quality management system to sustain a culture of operational excellence, meeting and exceeding the expectations of all stakeholders, including patients, customers and regulators.
Corporate Quality & Compliance (CQC) team regularly updates sites as per the requirement for continual improvement. The Corporate Quality & Compliance (CQC) team ensuring to follow a standardized global quality system procedures ensuring consistency, effectiveness and efficiency during the manufacture of APIs and formulations at all sites. CQC monitors effectiveness of quality systems of manufacturing sites and Contract Manufacturing sites through periodic quality reviews, periodic audits and review of compliance to regulatory inspections. Quality reviews focus on review of batch failures, batch rejections, market complaints, deviations, various Corrective and Preventive actions planned, etc.
We are having world class & robust quality systems to ensure that all the products manufactured are consistently safe and of good quality. Our aim is to deliver highest quality products at affordable prices. The company has well qualified and trained personnel in quality department to ensure GMP compliance.
We are committed for the delivery of Affordable and Quality Products to Patients, a fundamental element of our Company’s Mission and Vision.
- Company shall establish compliance with applicable quality regulations, codes and standards for its manufacturing site, including contract manufacturing sites.
- Deliver high quality products that patients can trust.
- Continuous improvement and innovation to improve our Facilities, Products, Processes and Procedures.
- All employees have the appropriate education, training, skills and experience to carry out their work competently.
This policy will set the framework for driving our quality programmes to create a sustainable quality culture for continual improvement
Quality Control
At Britannia Biological LLP, our mission is to provide reliable, safe and affordable medicines to patients worldwide, thus helping people to live healthier lives. Right from the procurement to the completed formulations, our stringent procedures ensure that the products are safe, effective and compliant with the International standards.
Efforts are underway to get our fully equipped laboratories accredited as the Research & Development Center by the Government of India.
Our quality policy stands committed to maintaining the good manufacturing practices, conform to the International standards and ensure a timely supply of goods with cost-effectiveness. We believe in achieving the highest level of customer satisfaction and market leadership in domestic, as well as overseas markets, by implementing the Quality Management Systems (QMS) on a continual basis.
Quality Assurance
Britannia Biological LLP is committed to total quality management. The manufacturing process is carried out under strict supervision of our technically competent staff as per the pre-defined processes and procedures. To ensure that the cGMP standards are met and products comply with international quality standards; quality control measures have been imbibed at various stages of production starting from approval of raw materials, in-process materials and extends to checking of finished products. The Batch Manufacturing Records and Batch Packaging Records are maintained for all manufactured products. The Final products are tested to the strictest of the available international pharmacopeial standards and norms. Stability studies are conducted on all our manufactured products.
We have well equipped chemical and instrumental laboratories with modern and sophisticated instruments such as H.P.L.C., H.P.T.L.C., L.C.M.S., G.C., I.R., U.V. Spectrophotometer, Polarimeter, Karl Fischer Titrators, etc. All equipment used in manufacturing, testing and packaging of the materials are regularly maintained and calibrated both at our in-house and by third party laboratories.
High quality performance standards are achieved through qualified and experienced staff, modern equipment, documented procedures and an established quality assurance system. The Quality Assurance team functions independently for monitoring & controlling the various activities of each functional department as pre defined in the S.O.P.’s and authenticated guidelines.
Regulatory compliance
Britannia Biological LLP is ISO 9001-2000 and WHO GMP certified.
The practices at Britannia Biological LLP are adherence to latest quality & safety standards. We ensure the implementation of cGMP standards, follow our in-house S.O.P’s, and pharmacopeial specifications. Most of our products are supported by the technical packages comprising of Drug Master files, Product Dossiers, Free sale certificates, Certificate of Pharmaceutical Products, etc.
Environmental Compliance
The intermediates, wastes and effluents are treated effectively so as to ensure compliance with environmental norms. Our environmental policy is to produce highest quality products in harmony with the ecological system and to minimize the damage to the environment by complying with all the statutory regulations and ISO-14001 standards.
Manufacturing Facilities
Britannia Biological LLP has 3 cGMP compliance manufacturing facilities located in Assam, Gujarat and Madhya Pradesh, India.
Each of our manufacturing facilities is designed, equipped and operated to deliver high quality products within defined cost and delivery schedules. We have capabilities in wide range of pharmaceutical products and have handled varied process reactions and reactor volumes up to 12KL.
Our commitment to quality and productivity is reflected in the implementation of total quality management processes at every stage of the manufacturing life cycle which is acknowledged by our ever expanding list of clientele globally
Production Capabilities
- Production Capabilities
- Production Units
- Total reactors volume of ~465 KL (Reactor capacity ranging from 100 liter to 12 KL).
- Clean rooms of 8 modules available for manufacture of APIs, compliant to c GMP standards.