We provide caring attention through expertise and knowledge—backed by state-of-the-art technology and quality systems
CAPTEK has developed a comprehensive understanding of the challenging nuances distinct to softgel manufacturing. Since inception, we have been focused on delivering the commercial capability of producing softgels in an ICH Q10 Part 210/211 environment 210/211-compliant GMP infrastructure. We are able to support customers on new product development and/or ANDA or 505(b)(2).
Our validation master plan covered the entire scope of facility construction and commissioning which included the operational equipment as well as process and product validation. All developed methods, method transfers, and method validations are validated per current pharmaceutical standards. Instruments are calibrated IQ, OQ, PQ. CAPTEK’s quality control has the capacity to conduct all IQ, OQ, and DQ necessary for all pharmaceutical applications.
Our facility and our end-to-end process flows were designed to maximize segregation to minimize cross-contamination, thereby creating and optimizing a natural propensity of SOP compliance. Our stream-lined workflows are complemented by our manufacturing strategy of using commercial equipment -even during research and development- which allows our customers to scale up quickly as we do not have to validate two different process streams.
Our Commitment To Quality Is An Ongoing Process
CAPTEK’s quality control ensures that our SOPs meet the CFRs and that appropriate action is executed following regulatory or customer audit and internal observation. Maintaining compliance requires ongoing systematic training and strict adherence to updates in regulations, new regulations, document control, and effective dates.
Our QC is aligned to foster rich working relationships with local authorities from LA county to San Diego county such as CUPA, CUPA’s fire department, and the water board. We work with them on a daily basis. We also have a long successful history of working with USDA and USDC. CAPTEK is also capable of providing international logistic expertise in getting permits for markets such as the EU and China and registrations in Latin America, Canada, Taiwan, and Korea.
Robust Experience With Regulatory Bodies
We’re always looking at what is best industry practice, what is the industry moving towards, and how we can stay current and innovate. There is an ongoing collaborative discussion with industrial groups such as Asq, Nia, NPA, NSF. CAPTEK is unique in that we have robust experience with the regulatory bodies because we’ve worked with them before. We know their procedural nuances allowing us to be very thorough overcoming challenges that would be difficult for companies that are not as knowledgeable.
CAPTEK has the capability to provide documentation directly to an FDA inspector, on behalf of the customer, and communicate directly with the FDA as the designated subject matter expert. Because of our deep understanding of the manufacturing process, we thereby avoid potential negative observations during registration for brand owners who bear the responsibility of registration. We can also help them with the requisite documentation, statements, and authorizations. We assist as much as possible including communicating directly with the US State Department.
At CAPTEK, your project is out top priority. Benefitting from the technical competence that CAPTEK Softgels as an organization brings to the pharmaceutical industry, we are unmatched in our ability to service our customer’s needs.
Speak With An Expert
Quality & Validation Specialist
Hiren offers 28 years of pharmaceutical development and manufacturing experience with emphasis on product/process development, validation and quality. Hiren also leads the quality unit and CAPTEK’s product development/validation team. With his oversight of product development, validation and quality at Captek Pharma, Hiren is prepared to discuss any challenges on your upcoming project.