Technical Consultant
1. Technical Consultant
2. Contract Manufacturing
3. Trading
4.Seminars / Workshops
Current Good Manufacturing Practice (cGMP)
Quality Management, covering all aspects of Good Laboratory Practice    (GLP)
Internal and External Audits
Validation and Qualification
Regulatory Agency Documentation for DMF’s and formulation dossiers
  Good Manufacturing Practice (GMP)  
  Reviews, development and implementation of plans for new facilities and proposed facility upgrades to ensure cGMP requirements are met, for example covering:  
Buildings layout and internal construction/surface finishes
Materials flow and personnel movement
Product and materials storage and sampling
HVAC Systems
Water Systems

Preparation of documentation, such as Standard Operating Procedures (SOPs), manufacturing and packaging records, Quality Control specifications and test methods and validation protocols

Assessment of GMP compliance to International Regulatory Standards, covering the manufacture of :

Nonsterile formulations, such as tablets, capsules, creams, ointments, external and internal liquids.
Active Pharmaceutical Ingredients (API's)

As a technical consultant, Training should be regularly conducted by qualified individuals to the organizations and should cover (i.e. GMP and GLP), at a minimum, the particular operations that the employee performs and GMP as it relates to the employee's functions. 

Quality Management
Reviews of Quality Control sampling and testing programs to maximize use of resources
Analytical method validation
Development of analytical equipment calibration programs
Reviews and implementation of Good Laboratory Practice (GLP)
The preparation of laboratory documentation covering, for example:
Standard Operating Procedures
Test methods
Sampling plans
Internal and External Audits
Conducting mock GMP audits, prior to the customers and regulatory authority audits, to assess the level of GMP compliance
Participation in GMP audits by regulatory agencies and post audit follow up activities, such as the preparation of a response to any issued audit report
Validation and Qualification

The preparation of: :

Validation of Master Plans (VMPs)
Process Validation Protocols and Reports including review of data
Validation Protocols (covering DQ, IQ, OQ and PQ)
Validation reports including reviews of data
Analytical method validation protocols
Analytical method validation reports including reviews of data
Regulatory Agency Documentation

The preparation of: :

Drug Master Files for submission to the United States FDA and
the European Community, EDQM, MCC, TGA , Canadian Authorities and other semi regulated market
Drug Product Dossiers for  US , European Authorities and semi regulated market
Responses to audit reports and follow up activities
Site Master Files

Home  |  About us  |  Services  |  Products  |  Enquiry Form   |   Photo Gallery  |   Contact Us

Copyright @ 2009          Powered by Infowave Internet Solutions