Syngene International, the contract research arm of Biocon, on Monday candidates using Syngene's platforms, the Bangalore-based company said. 4 Online Dating Sites that Actually Work for FreeTop US Dating Sites|. Committed to creating a globally competitive Biotech ecosystem in India through skill development, Biocon Ltd introduces Biocon Academy - a Center of. Biocon Ltd, Bangalore, India FDA Inspection History (October 1, to December 13, ) .. A map of the floor plan showing the sampling location is helpful. The use of expiration dating is probably unmanageable with.
No establishment of procedures designed to prevent microbiological contamination of sterile drug products. Validation of the effectiveness of disinfectants is not performed, there are no disposal records for expired cleanroom garments, and staff were observed picking up cleaning cloths that had been dropped on the floor. Data from the leak testing of sterile gloves is not documented. Deficient procedures for cleaning and maintaining equipment.
The firm lacks a scientific rationale for its disinfecting practices, numerous surfaces are not routinely disinfected, and inquiries into microorganisms found during previous investigations were delayed by months. Lack of authority in the quality control unit. The inspectors noted that vendor qualification procedures are not enforced for sterile gloves and that expired materials are in unrestricted use.
Lack of training for employees who manufacture and process drugs. Lack of scientifically sound laboratory controls.
The firm lacks procedures adequate to assure the identity, strength, quality, and purity of drug products. The pH testing protocol of samples is also deficient.
Labeling procedures are not followed. Rejected labels can be found in an unsecured waste bin, rather than under lock and key. The CSO has industry experience as a quality manager. The emphasis of the inspection was on aseptic filling and the supporting microbiology programs, which makes it interesting to pharmaceutical microbiologists. As we have come to expect, the FDA Form observations were often relatively poorly organized and so heavily redacted to be difficult to read and comprehend.
Redaction is considered necessary to eliminate confidential information, but it significantly reduces the usefulness of the FDA Form as a learning tool to outside interests. Division as to areas of non-compliance with the GMP regulations, which should be cited in each section as in a warning letter, would be helpful.
In terms of organization, the EMA policy of classifying the observations into critical, major and minor and listing them accordingly is preferred. It has been suggested that the observations are listed in order of importance, but we cannot be certain that is so in this case or any other case.
The inspection was conducted over seven days. Observation 1 - Investigations A. The extension of a failure investigation or a risk assessment to other batches within a specified time frame is a consistently cited issue during FDA inspections. What should that time frame be? How conservative should a company be in terms of extending their investigations, so as not to be secondguessed by future FDA investigators?
The EIR documents the investigation of visible particulates in long term and accelerated stability batches of a single product that went back to August The investigators determined that the investigation was protracted, poorly documented and inadequate.
The visual inspection reports prior to product release and customer complaints did not discover these particles outside of the stability samples.
Intrinsic particulates are difficult to eliminate as they are related to both the properties of the drug substance and the drug formulation and might only appear late in the product shelf life.
The FDA has taken an aggressive stance on foreign matter in injectable products, going as far as encouraging companies to recall batches with isolated customer complaints.
In the view of the author, this stance has led to drug shortages. Visual inspection is a probabilistic activity; so it is not possible to exclude every defect from a large-sized batch of product. Furthermore, the author believes that visible foreign matter particles occasionally found in individual vials, when injectable products have limits for subvisible particulates that may penetrate the vascular system, i.
However, they as extrinsic matter can be mitigated by attention to the procurement, cleaning, and sterilization of primary packaging components. Reviewing how an SOP update would affect marketed batches implicated in an investigation appears to be a new requirement.
This issue would be addressed during an investigation in terms of the change control documentation, which drives the SOP revisions, not the other way around.
However, SOPs must be current with compendial and regulatory changes and subject to periodic review and revision. Observation 2 - Sterilization Process Validation A. Participation in a media fill that is conducted periodically, i. However, the lack of participation due to scheduling contraints may define the range of activities of an operator are qualified to conduct in each area and their inclusion in a future media fill must be ensured by the company. The challenges in staffing an aseptic processing area may require some flexibility.
The EIR showed that the media fill participation of the operators was assumed and their involvement in media fills including critical interventions poorly documented. The company committed to define the requirement of the operators. The FDA investigators are correct.
The interventions conducted by an operator during a media fill should be defined in the media fill protocol and documented in the batch record.
They may be routine interventions like refilling a stopper bowl or non-routine like responding to a power outage. The media fill batch record should capture any stop-start times not just the total duration of the media fill. Media fills must be fully documented.Biocon Academy Corporate Film
As the integrity of sterile gloves is critical in preventing microbial contamination, the glove integrity testing should be validated to its effectiveness.
Investigations into environmental monitoring EM excursions should trigger a review of environmental controls, batch record review, result in the implementation of corrective actions, and in limited cases revalidation of the aseptic processing.
Observation 3 - Environmental Monitoring A,B. This would include operators who mainly work in the surrounding ISO 7 area but conduct any interventions in the ISO 5 aseptic processing areas such as EM and removing rejected vials. GMP cleanliness classifications, i. EM locations should be risk based and defined in the environmental monitoring procedures. A map of the floor plan showing the sampling location is helpful. Swab sampling conducted in the aseptic filling areas must comply with the procedure found in the SOP.
The location of the particle counter when monitoring the filling operation should be based on the risk of product exposure.
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Smoke studies may be helpful in determining the location of the particle counter, however, their capacity to distort laminar airflow during routine monitoring should be considered. Companies should be able to establish sampling locations based on practical considerations. Observation 4 - Aseptic Process Procedures A. The rationale for an in-process bioburden program should be available for regulatory review. This would include sampling after each critical processing step and the bioburden limits adopted.
Conducting disinfectant validations inside a cleanroom, as recommended in the EIR makes no sense, if they involve taking live organisms into critical areas in the facility. Sampling surfaces prior to and after sanitization is unlikely to demonstrate adequate log reductions expected for validation purposes because of the low counts on these surfaces but will demonstrate the overall sanitization effectiveness.
The ability of a disinfectant to eliminate representative microorganisms, including spore-former, from different surfaces found in the facility can be determined in laboratory studies.
Observation 4, B is a very questionable observation. Cleanroom garments must be managed to control microbial contamination originating from operators. Multiple uses of the same garments in an aseptic processing area should be discouraged. If they are clean, sterilized and reused when they should be inspected for damage prior to cleaning and, if practical, repaired.
The use of expiration dating is probably unmanageable with cleanroom garments, but first in, first out inventory control is recommended. AxiCorp is now an autonomous subsidiary of Biocon and the most successful Indian owned German pharmaceutical company.
It is a It also launched Abraxane in the UAE. Amylin provides expertise in peptide hormone development, particularly in the area of phybrid technology and metabolic disease therapeutics. Biocon will utilise its expertise in recombinant microbial expression and experience in preclinical and clinical development of diabetes products to manufacture the compound.
The companies are co-developing candidate products based upon IATRICa's technology platform and Biocon's expertise in drug development, biologics manufacturing, and clinical research.
The goal of this collaboration is to develop a therapeutic vaccine where the T cell mediated immunity is enhanced and maintained against a tumor which otherwise evades immune responses. Methods of developing, characterising and scaling up of conjugated monoclonal antibody production are being currently studied.
Mylan and Biocon will share development, capital and other costs to bring products to market.
The partnership was initiated in Biocon's strategic partnership with Vaccinex allows access to their proprietary human antibody platform technology, thereby providing a strong IP protection to Biocon's antibody pipeline. Biocon receives an upfront licensing fee and, following approval in the licensed territories, royalties from Abraxis BioScience. The partnership has also helped Biocon's Oncotherapeutics division add another frontline anti-cancer drug—Abraxane—to its portfolio.
In-licensed from Abraxis BioScience, Biocon has obtained the rights to market Abraxane in India for the treatment of breast cancer. Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products, and will have a cost and profit share arrangement globally. It also researches and develops a range of microbial-derived pharmaceutical products for diseases spanning the cardiovascular, diabetes, nephrology, inflammatory and oncology areas.
Non-clinical research[ edit ] Biocon scientists take up toxicology and pharmacology studies to establish proof-of-concept and provide assurance of safety in molecules under investigation.
They plan, develop and execute studies that meet global regulatory requirements. Clinical research[ edit ] Biocon develops clinical protocols for several novel drugs.
It conducts studies like assessment of novel biomarkers to understand the safety and efficacy of molecules in clinical trials. Till date Biocon has filed nearly 1, patent applications and hold over 1, patents and trademark registrations globally, covering technology areas of fermentation, protein purification, drug delivery systems and bio-therapeutic molecules.