GMP Quality Consultant Services
RAISING SUN also serving of quality systems of cGMP for small, start up and middle level companies of manufacturing of Bulk intermediates and API’s (Active Pharmaceutical Ingredients) companies to establish Quality, efficacy and cost effectiveness that will be approved the Audits / inspections and to deliver high quality products.
We provide consulting and training on regulatory cGMP compliance, validations and Qualifications continuous improvement of manufacturing processes.
Quality Systems: We can create, review, implement or improve current Quality Management Systems (QMS), for all departments in an organization
Training: We can conduct the training programs at your site and we offer several courses a year at various international sites.
Auditing: We perform all types of GMP and GLP Audits and provide a very detailed, specific report of recommended actions, including full references to the pertinent regulations and guidance documents
We also offer audit-readiness assessments (mock audits) of your facility
Management: We can assist with management strategies, especially for small, start up and middle level companies that want to set up the most cost effective and efficient compliance team possible with limited resources.
Facility Monitoring: We can review your current Facility Monitoring program to ensure it is robust enough to approve the audits.
We can help you to analyze the locations that show frequent excursions for how to correct and handle the situations.
We can also analyze the data, create trend reports, and prepare, review and handling the validation and qualification protocols and reports.
Supplier / Vendor audits: We can conduct on-site supplier audits on your behalf to ensure that their manufacturing activities are being executed according to your specifications and the applicable regulations.
We have experienced and professional GMP auditors available to conduct supplier audits
Additionally, if your products are being manufactured by a contract manufacturer then the PIC/S GMP code specifies as follows:
“The Contract Giver is responsible for assessing the competence of the Contract Acceptor to carry out successfully the work required and for ensuring by means of the contract that the principles and Guidelines of GMP as interpreted in this Guide are followed.”
It is your responsibility to ensure that your suppliers’ manufacturing processes meet the appropriate standards and regulations.
International supplier audit tours: We often audit overseas suppliers for our clients – suppliers who may also supply you. You can register your interest in a shared audit for a specific supplier. This will allow you to share the costs of the audit with other customers of that supplier (with confidentiality preserved between all parties).