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Semler Research Cgmp Consultancy, Audit Services

Posted at: Offers to Sell and Export | Posted on: Tue 23 Mar, 2010 5:03 am |
 
semler research cgmp audit
Products Photos CatalogSemler Research Cgmp Photos Catalog



We provide consultancy services on cGMP compliance to a pharmaceutical organization. Our expert team



will review and upgrade the Quality Management Systems with respect to current Good Manufacturing Practices and Regulatory Requirements.

Our approach :

- To perform GAP analysis to identify the weaknesses of the systems

- To make a master plan to plug the identified gaps

- To review and upgrade the Quality Management Systems

- To train and increase the competency levels of employees

- To review and compare the improvements at stipulated timelines and update the Management

- Implementation of ICH Q8, ICH Q9 and ICH Q10

- Qualification and validation of facility, equipment, HVAC and water system

- To establish Quality Management System

- Training on GMP / GLP / GCP

Third Party audit services

We provide the following services

- Auditing of Vendors such as Raw Material manufacturers for API and excipients; Packaging Materials

- Auditing of Contract Manufacturing Sites

- Auditing Contract Analytical Laboratories

- Market complaint investigation of the third party manufacturer’s

- Providing troubleshooting of process / analytical problems

- Monitoring of Exhibit Batch and Concurrent Validation Activities.

Generic Formulations:

At SRC, we provide facility for contract manufacturing with the following approach.

- State-of-the art facilities for soft gelatin capsules, which adhere to stringent specifications of cGMP and the facility is ready for International regulatory approvals.

- Qualified and experienced technical team in the areas of manufacturing, quality control, quality assurance, research and development, for all range of products.

- Experienced professionals and highly qualified management and staff, with SAP ERP and Economic Value of Strategic Alliance

Contract Manufacturing with SRC enables pharmaceutical companies to:

- Reliable supply of quality products - Validated and approved processes and in compliance with the registration file.

- Minimize investments in capital-intensive facilities.

- Improve net earning and cash flow.

- Divert resources to focus on their core competencies – R&D and marketing.

- All products are analyzed and released by our quality control staff before shipment.

- Monitor and optimize the timeliness of our delivery and keep it up to our customer’s full satisfaction



Company Contact:

semler photo
Contact Name: Mr. Subbaiah Md
Company Name: Semler Research Centre
Email: Email
Tel: 91-80-26640681
Fax: 91-80-26640683
Street Address: #75A, 15th Cross,
1st Phase, J.P.Nagar, Bangalore 560078
India
Website: http://www.semlerresearch.com
Member name: semler
Country: India-IN India
Member Since: 22 March 2010
Total Leads: 10 semler Import Export Business Leads
Business focus: Contract Research, Clinical Research, Formulation and Pre-Formulation Services
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