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International quality standards : GMP, USFDA, REACH, Six Sigma, ISO etc

Features

Benefits

• Guiding the organization to establish documentation to meet regulatory requirements and filing the required documents like DMFs till the audit and approvals for the following international standards.
• [ISO 9001:2008, ISO14001:2000, ISO18000, National GMP, WHO GMP , EU GMP, USFDA, COS/CEP (EUROPE), TGA Australia and other regulatory approvals]
• Third party audits for vendor qualifications.
• Validations/Qualifications important tool for Quality Management System and mandatory to meet regulatory requirements.
• Trainings on ISO, GMP, Quality Assurance (all types of validations) & internal auditors to develop and improve competency level of personnel.
• Develop Audit systems for continuous monitoring of Quality Management System implementation
• Taking up Annual maintenance contracts for QA & RA.
• Project management for MSMEs - planning the facility as per cGMP compliances, execution, facility qualifications. These can be for APIS, formulations - sterile and non-sterile.
• Development of QMS for manufacturers of excipients, primary packaging and secondary packaging materials manufacturers.

• Well established documented system to meet regulatory requirements.
• Very good culture.
• System oriented organization.
• Cost effective.
• Well validated procedures and qualified systems.
• Develops competitive and skilled personnel in an ongoing manner.
• Meets regulatory requirements.
• Facilitates Quality Management system.
• Cost effective implementation of QA & RA activities without disturbances due to personnel attrition.
• Due to significant experience of the consultants, the compliance as per GMY norms becomes easier. Due to the networking ability of consultants, this can be cost effective.
• The awareness of such manufacturers is low and consultants will make a world of difference and bring these manufacturers into the mainstream

Focus Verticals : Pharmaceutical Industries both bulk and Formulations. (SIX SIGMA and ISO  for all sectors)