Quality
Our commitment to Quality is uncompromising and we demonstrate it by:
Document & Data Control
Vendor Qualification
Self-Inspection
Recall Procedure
Training & Development of Personnel
Change Control/Deviation/CAPA
SOPs
IPQA
Annual Product Review
Validation/Qualification
Quality Policy
Bueno Saludcare is committed to the delivery of safe and effective products to patients and consumers, a fundamental element of our company’s purpose and mission.
To meet this commitment, Bueno Saludcare maintains a quality-focused culture to ensure the highest priority is placed on the safety, efficacy and reliability of our products, and the safety of our patients and consumers.
Bueno Saludcare leaders are committed to maintaining a quality culture with appropriate systems and processes in place to drive quality-focused behavior and ensure decision making based on what is best for product quality, patient and consumer safety, and protection of bueno saludcare’s reputation and business.
Each person in bueno saludcare is accountable for ensuring product quality, and patient and consumer safety. all colleagues and contingent workers have the appropriate education, training, skills and experience to carry out their work competently, in accordance with applicable regulations and bueno saludcare policies and procedures.
Bueno Saludcare’s business is conducted in compliance with applicable quality regulations, codes and standards.
Records, documentation and data are managed in accordance with applicable regulations.
Processes for escalating issues to ensure product integrity and patient and consumer safety are in place and consistently used.
Bueno Saludcare’s quality policy is implemented through a comprehensive quality management system. our performance is monitored and regularly reviewed to ensure our standards of conduct meet our high expectations of quality for our patients, customers, and stakeholders.
Regulatory Affairs
We pride ourselves on having a top-notch regulatory team. Our in-house regulatory affairs professionals bring a wealth of experience in regulatory, clinical, and Quality Assurance fields, combining scientific and management expertise to drive the organization’s critical commercial objectives.
Our highly skilled team excels in all stages of drug development, adeptly implementing strategies for regulatory compliance throughout the drug approval and commercialization processes. We have a proven track record in preparing dossiers in eCTD/ CTD, ACTD, and various country-specific formats, adhering to the registration guidelines of both semi-regulated and regulated markets.
Our dedicated team is well-versed in the regulatory requirements for Pharmaceuticals, Nutritional products, and Cosmoceutical products, ensuring that these products are developed, manufactured, and controlled to meet the highest standards of quality, safety, and efficacy throughout their entire lifecycle.
We have a good data bank of dossiers which we keep upgrading as per the changing regulatory policies and procedures
Regulatory Affairs
Dossiers Products
Products
Country Marketing
Facility Highlights
A WHO-GMP approved facility located in Gallop Industrial location of Ahmedabad. It is pleasantly surrounded by an entire pharma ecosystem with many accessory industries in the near vicinity. The plant has following separate dedicated blocks section for production of :
Penicillin
Tablet
Capsule
Oral Suspension
Cephalosparin Oral
Tablet
Oral Suspension
Cephalosparin Parentral
Dry Powder for Injection
General
Tablet
Capsule
Sachet
Liquid
Ointment
We are enthusiastic about positioning our site as a premier manufacturing hub for Amoxiclav range of products. With the support of our highly skilled team, access to premium raw materials, and state-of-the-art facilities specifically designed for handling this sensitive product, we are confident in our ability to achieve this goal. Our unwavering commitment to excellence in formulation and manufacturing drives us to continually improve our processes, bringing us closer to our vision of being a leading Beta lactam formulation producer.
Facility Features
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Build up area of Approx 2064 sq meter
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Advance Quality Area of 750 sq meter
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Formulation and Development Unit along with ADL
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Dedicated Beta Lactam Block
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Raw Material procurement from Internationally Accredited Manufacturing facilities
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Low RH Facility with Dedicated AHUs & Dehumidifiers
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Processing of Raw Material to Control the Inherent Water Content
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Highly Effective Machines
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Advance Autocoaters
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Highly efficient and dedicated utility systems
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The Manufacturing operations are throughout monitored by Quality Assurance department with effective QMS
Manufacturing Blocks
Employees Across Country
Billion Tablet Annually
Million Bottles
Million Sterile Injections
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